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Paediatr Drugs. 2014 Aug;16(4):321-30. doi: 10.1007/s40272-014-0075-3.

Awareness and utilization of reporting pathways for adverse events following immunization: online survey among pediatricians in Russia and Germany.

Author information

1
Division of Pneumonology, Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353, Berlin, Germany.

Abstract

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.

PMID:
24849291
DOI:
10.1007/s40272-014-0075-3
[Indexed for MEDLINE]

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