OBJECTIVES: Vaccine safety surveillance is highly dependent on accurate reporting of adverse events following immunization (AEFI). An online survey was conducted to assess the utilization of AEFI reporting standards and pathways among pediatricians in Germany, and in Russia where pediatric specialization begins in medical school. METHODS: In May 2011, a 31-item online questionnaire was sent to members of the German Professional Association for Pediatricians (BVKJ) and the Union of Pediatricians of Russia (UPR), capturing information on vaccine safety training, awareness of AEFI reporting pathways, and use of standardized case definitions for the ascertainment of AEFI. A convenience sample of 1,632 completed online surveys was analyzed. RESULTS: Participating pediatricians reported spending approximately 50 min per 8-hour workday on vaccine safety consultations, but only 42 % (56 % UPR, 26 % BVKJ) have ever received any formal vaccine safety training. Two-thirds reported having observed AEFI in their practice, but only one-third utilized standardized case definitions for case ascertainment. Only 35 % of participants named accurate AEFI reporting pathways. Every second pediatrician would report AEFI to institutions that are not primarily in charge of vaccine safety surveillance; the remaining reports would either be lost or delayed. Pediatricians who had received formal vaccine safety training were significantly more likely to apply international safety standards and to report adequately, both at the p < 0.05 level. CONCLUSION: Pediatricians play a key role in the post-marketing surveillance of vaccine safety. The lack of training represents a missed opportunity. There may be a role for professional societies to improve vaccine safety training.
OBJECTIVES: Vaccine safety surveillance is highly dependent on accurate reporting of adverse events following immunization (AEFI). An online survey was conducted to assess the utilization of AEFI reporting standards and pathways among pediatricians in Germany, and in Russia where pediatric specialization begins in medical school. METHODS: In May 2011, a 31-item online questionnaire was sent to members of the German Professional Association for Pediatricians (BVKJ) and the Union of Pediatricians of Russia (UPR), capturing information on vaccine safety training, awareness of AEFI reporting pathways, and use of standardized case definitions for the ascertainment of AEFI. A convenience sample of 1,632 completed online surveys was analyzed. RESULTS: Participating pediatricians reported spending approximately 50 min per 8-hour workday on vaccine safety consultations, but only 42 % (56 % UPR, 26 % BVKJ) have ever received any formal vaccine safety training. Two-thirds reported having observed AEFI in their practice, but only one-third utilized standardized case definitions for case ascertainment. Only 35 % of participants named accurate AEFI reporting pathways. Every second pediatrician would report AEFI to institutions that are not primarily in charge of vaccine safety surveillance; the remaining reports would either be lost or delayed. Pediatricians who had received formal vaccine safety training were significantly more likely to apply international safety standards and to report adequately, both at the p < 0.05 level. CONCLUSION: Pediatricians play a key role in the post-marketing surveillance of vaccine safety. The lack of training represents a missed opportunity. There may be a role for professional societies to improve vaccine safety training.
Authors: Jens U Rüggeberg; Michael S Gold; José-Maria Bayas; Michael D Blum; Jan Bonhoeffer; Sheila Friedlander; Glacus de Souza Brito; Ulrich Heininger; Babatunde Imoukhuede; Ali Khamesipour; Michel Erlewyn-Lajeunesse; Susana Martin; Mika Mäkelä; Patricia Nell; Vitali Pool; Nick Simpson Journal: Vaccine Date: 2007-03-12 Impact factor: 3.641
Authors: Michael M McNeil; Rongxia Li; Susanne Pickering; Theresa M Real; Philip J Smith; Michael R Pemberton Journal: Vaccine Date: 2013-04-16 Impact factor: 3.641
Authors: Emma C Davies; Clare I R Chandler; Simeon H S Innocent; Charles Kalumuna; Dianne J Terlouw; David G Lalloo; Sarah G Staedke; Ane Haaland Journal: PLoS One Date: 2012-03-29 Impact factor: 3.240
Authors: Adriana Parrella; Annette Braunack-Mayer; Michael Gold; Helen Marshall; Peter Baghurst Journal: BMC Health Serv Res Date: 2013-08-15 Impact factor: 2.655
Authors: Christian Hoppe; Patrick Obermeier; Susann Muehlhans; Maren Alchikh; Lea Seeber; Franziska Tief; Katharina Karsch; Xi Chen; Sindy Boettcher; Sabine Diedrich; Tim Conrad; Bron Kisler; Barbara Rath Journal: Drug Saf Date: 2016-10 Impact factor: 5.606