Skip to main content

Awareness and Utilization of Reporting Pathways for Adverse Events Following Immunization: Online Survey Among Pediatricians in Russia and 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.

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2

Abbreviations

ACIP:

Advisory Committee on Immunization Practices

AE:

Adverse Event

AEFI:

Adverse Event Following Immunization

ADR:

Adverse Drug Reaction

BC:

Brighton Collaboration

BVKJ:

German Professional Association for Pediatricians (association for pediatricians in private practice in Germany; Berufsverband der Kinder- und Jugendärzte e.V.)

CDC:

US Centers for Disease Control

DCGMA:

Drug Commission of the German Medical Association (Ärztekammer der Deutschen Ärzteschaft)

DOH:

Department of Health

ECDC:

European Center for Disease Prevention and Control

EMA:

European Medicines Agency

HCP:

Health care professional

MOH:

Ministry of Health

OSCE:

Objective structured clinical examination

PEI:

Paul Ehrlich Institute

PHAC:

Public Health Agency of Canada

PROSPER:

Patient-Reported Outcomes Safety Event Reporting

UN:

United Nations

UPR:

Union of Pediatricians of Russia

VAERS:

Vaccine Adverse Event Reporting System

WHO:

World Health Organization

ГИCК им Tapaceвичa:

Russian Federal State Institution for Scientific Research, the Institute for Standardization and Control of Medical and Biological Preparations “L. A. Tarasevich”

CЭЗ:

Sanitary-Epidemiological Commission

ΦГУЗ:

Federal Centre of Hygiene and Epidemiology

References

  1. UNICEF. Global Immunization Data. 2012. http://www.who.int/immunization_monitoring/Global_Immunization_Data.pdf. Accessed April 4 2013.

  2. Collet JP, MacDonald N, Cashman N, Pless R. Monitoring signals for vaccine safety: the assessment of individual adverse event reports by an expert advisory committee. Advisory Committee on Causality Assessment. Bull World Health Organ. 2000;78(2):178–85.

    CAS  PubMed Central  PubMed  Google Scholar 

  3. Gust DA, Darling N, Kennedy A, Schwartz B. Parents with doubts about vaccines: which vaccines and reasons why. Pediatrics. 2008;122(4):718–25. doi:10.1542/peds.2007-0538.

    PubMed  Article  Google Scholar 

  4. Jo DS, Kim JS. Perspectives on vaccine injury compensation program in Korea: the pediatricians’ view. ClinExp Vaccine Res. 2013;2(1):53–7. doi:10.7774/cevr.2013.2.1.53.

    Article  Google Scholar 

  5. Graham JE, Borda-Rodriguez A, Huzair F, Zinck E. Capacity for a global vaccine safety system: the perspective of national regulatory authorities. Vaccine. 2012;30(33):4953–9. doi:10.1016/j.vaccine.2012.05.045.

    PubMed  Article  Google Scholar 

  6. Keller-Stanislawski B, Heuss N, Meyer C. Adverse events following immunisation in Germany from 1.1.2001 to 31.12.2003. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2004;47(12):1151–64. doi:10.1007/s00103-004-0946-9.

    CAS  PubMed  Article  Google Scholar 

  7. Tapiainen T, Prevots R, Izurieta HS, Abramson J, Bilynsky R, Bonhoeffer J, et al. Aseptic meningitis: case definition and guidelines for collection, analysis and presentation of immunization safety data. Vaccine. 2007;25(31):5793–802. doi:10.1016/j.vaccine.2007.04.058.

    CAS  PubMed  Article  Google Scholar 

  8. Rath B, Magnus M, Heininger U. Evaluating the Brighton Collaboration case definitions, aseptic meningitis, encephalitis, myelitis, and acute disseminated encephalomyelitis, by systematic analysis of 255 clinical cases. Vaccine. 2010;28(19):3488–95. doi:10.1016/j.vaccine.2010.02.053.

    PubMed  Article  Google Scholar 

  9. Muehlhans S, Richard G, Ali M, Codarini G, Elemuwa C, Khamesipour A, et al. Safety reporting in developing country vaccine clinical trials—a systematic review. Vaccine. 2012;30(22):3255–65. doi:10.1016/j.vaccine.2012.02.059.

    PubMed  Article  Google Scholar 

  10. Meranus D, Stergachis A, Arnold J, Duchin J. Assessing vaccine safety communication with healthcare providers in a large urban county. Pharmacoepidemiol Drug Saf. 2012;21(3):269–75. doi:10.1002/pds.2245.

    PubMed  Article  Google Scholar 

  11. Flood M. Medical Education in Russia. 2008. http://ezinearticles.com/?Medical-Education-in-Russia&id=2172157. Accessed 10 Dec 2012.

  12. Bundesministerium der Justiz Deutschland. Infektionsschutzgesetz - IfSG. 2013. http://www.gesetze-im-internet.de/ifsg/index.html#BJNR104510000BJNE001706116. Accessed 3 Oct 2013.

  13. WHO. Primary health care: International Conference on Primary Health Care, Alma-Ata, USSR, 6–12 September 1978. Nurs J India. 1979;70(11):285–95.

  14. Marcy S, Kohl KS, Dagan R, Nalin D, Blum M, Jones MC, et al. Fever as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation. Vaccine. 2004;22(5–6):551–6.

    Article  Google Scholar 

  15. Bines JE, Kohl KS, Forster J, Zanardi LR, Davis RL, Hansen J, et al. Acute intussusception in infants and children as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation. Vaccine. 2004;22(5–6):569–74.

    PubMed  Article  Google Scholar 

  16. Beigel J, Kohl KS, Khuri-Bulos N, Bravo L, Nell P, Marcy SM, et al. Rash including mucosal involvement: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5697–706. doi:10.1016/j.vaccine.2007.02.066.

    CAS  PubMed  Article  Google Scholar 

  17. Bonhoeffer J, Menkes J, Gold MS, de Souza-Brito G, Fisher MC, Halsey N, et al. Generalized convulsive seizure as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine. 2004;22(5–6):557–62.

    PubMed  Article  Google Scholar 

  18. Ruggeberg JU, Gold MS, Bayas JM, Blum MD, Bonhoeffer J, Friedlander S, et al. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5675–84. doi:10.1016/j.vaccine.2007.02.064.

    PubMed  Article  Google Scholar 

  19. Olson LM, Inkelas M, Halfon N, Schuster MA, O’Connor KG, Mistry R. Overview of the content of health supervision for young children: reports from parents and pediatricians. Pediatrics. 2004;113(6 Suppl):1907–16.

    PubMed  Google Scholar 

  20. Davis TC, Fredrickson DD, Arnold CL, Cross JT, Humiston SG, Green KW, et al. Childhood vaccine risk/benefit communication in private practice office settings: a national survey. Pediatrics. 2001;107(2):E17.

    CAS  PubMed  Article  Google Scholar 

  21. Sax LJ, Gilmartin SK, Bryant AN. Assessing response rates and nonresponse bias in web and paper surveys. Res High Educ. 2003; 44(4):409–31.

    Article  Google Scholar 

  22. Nulty DD. The adequacy of response rates for online and paper surveys: what can be done? Assess Veal High Educ. 2008; 33(3):301–314.

  23. Weisser K, Meyer C, Petzold D, Mentzer D, Keller-Stanislawski B. Adverse drug reactions following immunization in Germany pursuant to the German Infection Protection Act and the German Medicinal Products Act from January 1, 2004 to December 31, 2005. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2007;50(11):1404–17. doi:10.1007/s00103-007-0368-6.

    CAS  PubMed  Article  Google Scholar 

  24. McNeil MM, Li R, Pickering S, Real TM, Smith PJ, Pemberton MR. Who is unlikely to report adverse events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS)? Vaccine. 2013;31(24):2673–9. doi:10.1016/j.vaccine.2013.04.009.

    PubMed  Article  Google Scholar 

  25. Parrella A, Gold M, Marshall H, Braunack-Mayer A, Baghurst P. Parental perspectives of vaccine safety and experience of adverse events following immunisation. Vaccine. 2013;31(16):2067–74. doi:10.1016/j.vaccine.2013.02.011.

    PubMed  Article  Google Scholar 

  26. Parrella A, Braunack-Mayer A, Gold M, Marshall H, Baghurst P. Healthcare providers’ knowledge, experience and challenges of reporting adverse events following immunisation: a qualitative study. BMC Health Serv Res. 2013;13:313. doi:10.1186/1472-6963-13-313.

    PubMed Central  PubMed  Article  Google Scholar 

  27. Paveliu MS, Bengea-Luculescu S, Toma M, Paveliu SF. Perception on adverse drug reaction reporting by physicians working in southern Romania. Maedica (Buchar). 2013;8(1):17–25.

    Google Scholar 

  28. Stoynova V, Getov I, Naseva E, Lebanova H, Grigorov E. Physicians’ knowledge and attitude towards adverse event reporting system and result to intervention – randomized nested trial among Bulgarian physicians. Med Glas (Zenica). 2013;10(2):365–72.

    Google Scholar 

  29. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2009;32(1):19–31. doi:10.2165/00002018-200932010-00002.

    CAS  PubMed  Article  Google Scholar 

  30. Paul-Ehrlich-Institut. Meldeformulare zur Arzneimittelsicherheit. 2012. http://www.pei.de/DE/arzneimittelsicherheit-vigilanz/meldeformulare-online-meldung/meldeformulare-arzneimittelsicherheit-node.html;jsessionid=187867A5C55ED4CFB79D6CB7F9C5018B.1_cid344. Accessed 3 Oct 2013.

  31. Iskander JK, Miller ER, Chen RT. The role of the Vaccine Adverse Event Reporting system (VAERS) in monitoring vaccine safety. Pediatr Ann. 2004;33(9):599–606.

    PubMed  Article  Google Scholar 

  32. PHAC. Report of adverse events following immunization (AEFI). 2004. http://www.phac-aspc.gc.ca/im/aefi-essi-form-desc-eng.php. Accessed 31 Jan 2013.

  33. Letourneau M, Wells G, Walop W, Duclos P. Improving global monitoring of vaccine safety: a quantitative analysis of adverse event reports in the WHO Adverse Reactions Database. Vaccine. 2008;26(9):1185–94. doi:10.1016/j.vaccine.2007.12.033.

    PubMed  Article  Google Scholar 

  34. Haber P, Iskander J, Walton K, Campbell SR, Kohl KS. Internet-based reporting to the Vaccine Adverse Event Reporting System: a more timely and complete way for providers to support vaccine safety. Pediatrics. 2011;127(Suppl 1):S39–44. doi:10.1542/peds.2010-1722G.

    PubMed  Article  Google Scholar 

  35. Hinrichsen VL, Kruskal B, O’Brien MA, Lieu TA, Platt R. Using electronic medical records to enhance detection and reporting of vaccine adverse events. J Am Med Inform Assoc. 2007;14(6):731–5. doi:10.1197/jamia.M2232.

    PubMed Central  PubMed  Article  Google Scholar 

  36. Harpaz R, DuMouchel W, Shah NH, Madigan D, Ryan P, Friedman C. Novel data-mining methodologies for adverse drug event discovery and analysis. Clin Pharmacol Ther. 2012;91(6):1010–21. doi:10.1038/clpt.2012.50.

    CAS  PubMed Central  PubMed  Article  Google Scholar 

  37. Banerjee AK, Okun S, Edwards IR, Wicks P, Smith MY, Mayall SJ, et al. Patient-reported outcome measures in safety event reporting: PROSPER Consortium Guidance. Drug Saf. 2013;. doi:10.1007/s40264-013-0113-z.

    PubMed Central  PubMed  Google Scholar 

  38. CIOMS. Definitions and applications of terms for vaccine pharmacovigilance. 2012. http://whqlibdoc.who.int/publications/2012/9789290360834_eng.pdf. Accessed March 31 2013.

  39. Naessens JM, Campbell CR, Huddleston JM, Berg BP, Lefante JJ, Williams AR, et al. A comparison of hospital adverse events identified by three widely used detection methods. Int J Qual Health Care. 2009;21(4):301–7. doi:10.1093/intqhc/mzp027.

    PubMed  Article  Google Scholar 

  40. Planchamp F, Nguyen KA, Vial T, Nasri S, Javouhey E, Gillet Y, et al. Active drug monitoring of adverse drug reactions in pediatric emergency department. Arch Pediatr. 2009;16(2):106–11. doi:10.1016/j.arcped.2008.11.013.

    CAS  PubMed  Article  Google Scholar 

  41. Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, et al. Surveillance for safety after immunization: vaccine Adverse Event Reporting System (VAERS)—United States, 1991–2001. MMWR Surveill Summ. 2003;52(1):1–24.

    PubMed  Google Scholar 

  42. Feng JY, Chang YT, Chang HY, Erdley WS, Lin CH, Chang YJ. Systematic review of effectiveness of situated e-learning on medical and nursing education. Worldviews Evid Based Nurs. 2013;. doi:10.1111/wvn.12005.

    PubMed  Google Scholar 

  43. Smith PJ, Kennedy AM, Wooten K, Gust DA, Pickering LK. Association between health care providers’ influence on parents who have concerns about vaccine safety and vaccination coverage. Pediatrics. 2006;118(5):e1287–92. doi:10.1542/peds.2006-0923.

    PubMed  Article  Google Scholar 

  44. Hutchins SS, Jansen HA, Robertson SE, Evans P, Kim-Farley RJ. Studies of missed opportunities for immunization in developing and industrialized countries. Bull World Health Organ. 1993;71(5):549–60.

    CAS  PubMed Central  PubMed  Google Scholar 

  45. Maurer W, Seeber L, Rundblad G, Kochar S, Trusko B, Kisler B, et al. Standardization and simplification of vaccination records. Expert Rev Vaccines. 2014;13(4):545–59. doi:10.1586/14760584.2014.892833.

    CAS  PubMed  Article  Google Scholar 

  46. Rudiger M, Muller S, Neuwirth A, Kordonouri O, Guthmann F. Integrating problem-based learning into traditional medical courses: the PBL approach to pediatrics in Berlin. Z Arztl Fortbild Qualitatssich. 2003;97(4–5):339–41.

    PubMed  Google Scholar 

  47. Sarnquist C, Sawyer M, Calvin K, Mason W, Blumberg D, Luther J, et al. Communicating about vaccines and vaccine safety: what are medical residents learning and what do they want to learn? J Public Health Manag Pract. 2013;19(1):40–6. doi:10.1097/PHH.0b013e3182495776.

    PubMed  Article  Google Scholar 

  48. Poland CM, Poland GA. Vaccine education spectrum disorder: the importance of incorporating psychological and cognitive models into vaccine education. Vaccine. 2011;29(37):6145–8. doi:10.1016/j.vaccine.2011.07.131.

    PubMed  Article  Google Scholar 

  49. He Y, Rappuoli R, De Groot AS, Chen RT. Emerging vaccine informatics. J Biomed Biotechnol. 2010;2010:218590. doi:10.1155/2010/218590.

    PubMed Central  PubMed  Google Scholar 

  50. Davies EC, Chandler CI, Innocent SH, Kalumuna C, Terlouw DJ, Lalloo DG, et al. Designing adverse event forms for real-world reporting: participatory research in Uganda. PLoS One. 2012;7(3):e32704. doi:10.1371/journal.pone.0032704.

    CAS  PubMed Central  PubMed  Article  Google Scholar 

  51. WHO. Vaccine safety basics. 2013. http://www.vaccine-safety-training.org/. Accessed 3 May 2013.

Download references

Acknowledgments

The authors kindly thank the participating pediatric professional societies as well as their members for their participation in the online survey. The authors also express their gratitude to Olga Komarova for organizing the survey in Russia and to members of the Vienna Vaccine Safety Initiative Think Tank (www.vi-vi.org), who provided feedback to the concept and design of the survey.

L. Namazova-Baranova has received grant funding from Pfizer, payment for board activities from Pfizer and GSK, and payment for lectures from MSD, GSK, Pfizer and sanofi-pasteur. S. Muehlhans, M. von Kleist, T. Gretchukha, M. Terhardt, U. Fegeler, W. Maurer, G. Gaedicke, A.A. Baranov, and B.A. Rath declare that they have no conflicts of interest.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Barbara Rath.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Muehlhans, S., von Kleist, M., Gretchukha, T. et al. Awareness and Utilization of Reporting Pathways for Adverse Events Following Immunization: Online Survey Among Pediatricians in Russia and Germany. Pediatr Drugs 16, 321–330 (2014). https://doi.org/10.1007/s40272-014-0075-3

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40272-014-0075-3

Keywords

  • Aseptic Meningitis
  • Objective Structure Clinical Examination
  • Vaccine Safety
  • Vaccine Adverse Event Reporting System
  • Adverse Event Follow Immunization