Advertisement

Pharmaceutical Medicine

, Volume 31, Issue 1, pp 13–20 | Cite as

Factors that Motivate Healthcare Professionals to Report Adverse Drug Events: A Systematic Review

  • Samir Antonio Rodrigues Abjaude
  • Stephania Furlanetto Mieli
  • Zídia Rocha Magalhães
  • Leonardo Régis Leira PereiraEmail author
Systematic Review
  • 113 Downloads

Abstract

Introduction

The underreporting of adverse drug events (ADEs) is an important issue that affects the evaluation of the risk/benefit profile of drugs, with the potential for major impact on public health, such as undermining market regulation of drugs and reducing patient safety.

Objectives

The objective of this systematic review was to identify and categorize the factors that motivate ADE reporting by healthcare professionals.

Methods

A systematic review was conducted, based on the PRISMA guidelines, in the PubMed, Scopus, LILACS and SciELO databases, for studies published up to 30 November 2015. A search strategy was designed to identify published studies that evaluated factors that motivate professionals to report adverse events. Factors that were identified as influencing ADE reporting were subsequently categorized by the authors, to reveal common themes that might be used to improve ADE reporting rates.

Results

There were 410 potentially relevant studies identified, of which 133 were duplicates and 234 did not meet the inclusion criteria at initial screening. After reading in full, a further 15 articles were eliminated and 28 articles were included in the systematic review. It was observed that the majority of studies mainly contemplated pharmacists (n = 16) and physicians (n = 16). The seven major categories that motivate ADE reporting by health professionals are: knowledge of the ADE, incentives, notification methods, educational intervention, risk management, educational materials, and professional responsibility.

Conclusions

Factors that motivate healthcare professional to report ADEs can be classified into seven common themes. It is likely that multiple categories will need to be addressed as part of ongoing continuing education programs to increase motivation for ADE reporting by healthcare professionals.

Keywords

Electronic Supplementary Material Healthcare Professional Patient Safety Educational Intervention Adverse Drug Event 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

We thank Marilia Silveira de Almeida Campos for statistical cooperation and revision of the text.

Compliance with Ethical Standards

Funding

No sources of funding were used to assist in the preparation of this systematic review.

Conflict of interest

Samir Antonio Rodrigues Abjaude, Stephania Furlanetto Mieli, Zídia Rocha Magalhães and Leonardo Régis Leira Pereira have no conflicts of interest that are directly relevant to the content of this systematic review.

Supplementary material

40290_2016_174_MOESM1_ESM.pdf (40 kb)
Supplementary material 1 (PDF 40 kb)
40290_2016_174_MOESM2_ESM.pdf (92 kb)
Supplementary material 2 (PDF 91 kb)

References

  1. 1.
    Souza TT, Godoy RR, Rotta I, Pontarolo R, Fernandez-Llimos F, Correr CJ. Morbidade e mortalidade relacionadas a medicamentos no Brasil: revisão sistemática de estudos observacionais. Rev Ciênc Farm Básica Apl. 2014;35(4):519–32.Google Scholar
  2. 2.
    Camargo AL, Ferreira MBC, Heineck I. Adverse Drug reactions: a cohort study in internal medicine units at a university hospital. Eur J Clin Pharmacol. 2006;62(2):143–9.CrossRefPubMedGoogle Scholar
  3. 3.
    Pirmohamed M, James S, Meakin S, Verde C, Scott AK, Walley TJ, Farrar K, Parque BK, Breckenridge AM. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ. 2004;329(7456):15–9.CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. excess length of stay, extra costs, and attributable mortality. JAMA. 1997;277(4):301–6.CrossRefPubMedGoogle Scholar
  5. 5.
    Pal SN, Duncombe C, Falzon D, Olsson S. WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems. Drug Saf. 2013;36(2):75–81.CrossRefPubMedPubMedCentralGoogle Scholar
  6. 6.
    Baldoni AO, Pereira LRL. O impacto do envelhecimento populacional brasileiro para o sistema de saúde sob a óptica da farmacoepidemiologia: uma revisão narrativa. Rev Ciênc Farm Básica e Apl. 2011;32(3):313–21.Google Scholar
  7. 7.
    Abjaude SAR, Zanetti ACB, Marques LAM, Rascado RR. Omission in reporting: result of ignorance in pharmacovigilance. Revista da Universidade do Vale do Rio Verde Três Corações. 2013;10(1):267–76.CrossRefGoogle Scholar
  8. 8.
    Gavaza P, Brown CM, Lawson KA, Rascati KL, Wilson JP, Steinhardt M. Influence of attitudes on pharmacist’ intention to report serious adverse drug events to the Food and Drug Administration. Br J Clin Pharmacol. 2011;72(1):143–52.CrossRefPubMedPubMedCentralGoogle Scholar
  9. 9.
    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.CrossRefPubMedGoogle Scholar
  10. 10.
    Ribeiro-Vaz I, Herdeiro MT, Polónia J, Figueiras A. Strategies to increase the sensitivity of pharmacovigilance in Portugal. Rev Saúde Pública. 2011;45(1):129–35.CrossRefPubMedGoogle Scholar
  11. 11.
    Primo LP, Capucho HC. Educational interventions for stimulating voluntary reporting in a university hospital sentinel. R Bras Farm Hosp Serv Saúde São Paulo. 2011;2(2):26–30.Google Scholar
  12. 12.
    Gavaza P, Brown CM, Khoza S. Texas pharmacists’ opinions on reporting serious adverse drug events to the Food and Drug Administration: a qualitative study. Pharm World Sci. 2010;32:651–7.CrossRefPubMedGoogle Scholar
  13. 13.
    Su C, Ji H, Su Y. Hospital pharmacists’ knowledge and opinions regarding adverse drug reaction reporting in Northern China. Pharmacoepidemiol Drug Saf. 2010;19(3):217–22.CrossRefPubMedGoogle Scholar
  14. 14.
    Moher D, Liberati A, Tetzlaff J, Altman DG, the PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. J Clin Epidemiol. 2009;151(4):264–70.Google Scholar
  15. 15.
    Downs SH, Black N. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. J Epidemiol Commun Health. 1998;52:377–84.CrossRefGoogle Scholar
  16. 16.
    Vincent C, Stanhope N, Crowley-Murphy M. Reasons for not reporting adverse incidents: an empirical study. J Eval Clin Pract. 1999;5(1):13–21.CrossRefPubMedGoogle Scholar
  17. 17.
    Herdeiro MT, Polonia J, Gestal-Otero JJ, Figueiras A. Factors that influence spontaneous reporting of adverse drug reactions: a model centralized in the medical professional. J Eval Clin Pract. 2004;10(4):483–9.CrossRefPubMedGoogle Scholar
  18. 18.
    Smith DS, Haig K. Reduction of adverse drug events and medication errors in a community hospital setting. Nurs Clin N Am. 2005;40(1):25–32.CrossRefGoogle Scholar
  19. 19.
    Chaikoolvatana A, Chanakit T, Juengrakpong A. The evaluation of a recurrent adverse drug reaction prevention program in the North-East region of Thailand. J Med Assoc Thai. 2006;89(5):699–705.PubMedGoogle Scholar
  20. 20.
    Olmsted SS, Grabenstein JD, Jain AK, Lurie N. Patient experience with, and use of, an electronic monitoring system to assess vaccination responses. Health Expect. 2006;9(2):110–7.CrossRefPubMedPubMedCentralGoogle Scholar
  21. 21.
    Nichols V, Thériault-Duhé I, Touzin J, Delisle JF, Lebel D, Bussières JF, Bailey B, Collin J. Risk perception and reasons for noncompliance in pharmacovigilance: a qualitative study conducted in Canada. Drug Saf. 2009;32(7):579–90.CrossRefPubMedGoogle Scholar
  22. 22.
    Passier A, ten Napel M, van Grootheest K, van Puijenbroek E. Reporting of adverse drug reactions by general practitioners: a questionnaire-based study in the Netherlands. Drug Saf. 2009;32(10):851–8.CrossRefPubMedGoogle Scholar
  23. 23.
    Chopra D, Wardhan N, Rehan HS. Knowledge, attitude and practices associated with adverse drug reaction reporting amongst doctors in a teaching hospital. Int J Risk Saf Med. 2011;23(4):227–32.PubMedGoogle Scholar
  24. 24.
    Arnott J, Hesselgreaves H, Nunn AJ, Peak M, Pirmohamed M, Smyth RL, Mark A, Turner MA, Young B. What can we learn from parents about enhancing participation in pharmacovigilance? Brit J Clin Pharmacol. 2012;75(4):1109–17.CrossRefGoogle Scholar
  25. 25.
    Gavaza P, Bui B. Pharmacy students’ attitudes toward reporting serious adverse drug events. Am J Pharm Educ. 2012;76(10):194.CrossRefPubMedPubMedCentralGoogle Scholar
  26. 26.
    Baysari MT, Westbrook JL, Egan B, Day RO. Identification of strategies to reduce computerized alerts in an electronic prescribing system using a Delphi approach. Stud Health Technol Inform. 2013;192:8–12.PubMedGoogle Scholar
  27. 27.
    Stewart D, MacLure K, Paudyal V, Hughes C, Courtenay M, McLay J. Non-medical prescribers and pharmacovigilance: participation, competence and future needs. Int J Clin Pharm. 2013;35(2):268–74.CrossRefPubMedGoogle Scholar
  28. 28.
    Yip J, Radford DR, Brown D. Summary of: How do UK dentists deal with adverse drug reaction reporting? Brit Dental J. 2013;214(8):412–4.CrossRefGoogle Scholar
  29. 29.
    Abubakar AR, Simbak NB, Haque M. Pharmacovigilance study: awareness among medical students of a new medical school of Malaysia. Int J Pharm Res. 2015;7(1):83–8.Google Scholar
  30. 30.
    Matos C, Van Hunsel F, Joaquim J. Are consumers ready to take part in the Pharmacovigilance System? A Portuguese preliminary study concerning ADR reporting. Eur J Clin Plarmacol. 2015;71:883–90.CrossRefGoogle Scholar
  31. 31.
    Mcgettigan P, Golden J, Conroy RM, Arthur N, Felly J. Reporting of adverse drug reactions by hospital doctors and the response to intervention. Brit J Clin Pharmacol. 1997;44:98–100.CrossRefGoogle Scholar
  32. 32.
    Cosentino M, Leoni O, Oria C, Michielotto D, Massimo E, Lecchini S, Frigo G. Hospital-based survey of doctor’s attitudes to adverse drug reactions and perception of drug-related risk for adverse reaction occurrence. Pharmacoepidemiol Drug Saf. 1999;8:S27–35.CrossRefPubMedGoogle Scholar
  33. 33.
    Castel JM, Figueras A, Pedrós C, Laporte JR, Capellà D. Stimulating adverse drug reaction reporting: effect of a drug safety bulletin and of including yellow cards in prescription pads. Drug Saf. 2003;26(14):1049–55.CrossRefPubMedGoogle Scholar
  34. 34.
    Bäckström M, Mjörndal T. A small economic inducement to stimulate increased reporting of adverse drug reactions—a way of dealing with an old problem? Eur J Clin Pharmacol. 2006;62:381–5.CrossRefPubMedGoogle Scholar
  35. 35.
    Wallerstedt SM, Brunlöf G, Johansson ML, Tukukino C, Ny L. Reporting of adverse drug reactions may be influenced by feedback to the reporting doctor. Eur J Clin Pharmacol. 2007;63(5):505–8.CrossRefPubMedGoogle Scholar
  36. 36.
    Granas AG, Buajordet M, Stenberg-Nilsen H, Harg P, Horn AM. Pharmacists’ attitudes towards the reporting of suspected adverse drug reactions in Norway. Pharmacoepidemiol Drug Saf. 2007;16:429–34.CrossRefPubMedGoogle Scholar
  37. 37.
    Irujo M, Bietia G, Bes-Rastrollo M, Figueiras A, Hernandez-Díaz S, Lasheras B. Factors that influence under-reporting of suspected adverse drug reactions among community pharmacists in a Spanish region. Drug Saf. 2007;30(11):1073–82.CrossRefPubMedGoogle Scholar
  38. 38.
    Cornelissen L, Puijenbroek E, Grootheest K. Expectations of general practitioners and specialist doctors regarding the feedback received after reporting an adverse drug reaction. Pharmacoepidemiol Drug Saf. 2008;17:76–81.CrossRefPubMedGoogle Scholar
  39. 39.
    Wu JH, Shen WS, Lin LM, Greenes RA, Bates DW. Testing the technology acceptance model for evaluating healthcare professionals’ intention to use an adverse event reporting system. Int J Qual Health Care. 2008;20(2):123–9.CrossRefPubMedGoogle Scholar
  40. 40.
    Ekman E, Bäckström M. Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden. Eur J Clin Pharmacol. 2009;65:43–6.CrossRefPubMedGoogle Scholar
  41. 41.
    Polimeni G, Russo A, Catania MA, Aiello A, Oteri A, Trifirò G, Calapai G, Sautebin L, Iacobelli M, Caputi AP. Drug safety information through the internet the experience of an Italian website. Drug Saf. 2009;32(3):245–53.CrossRefPubMedGoogle Scholar
  42. 42.
    Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin Pharmacol. 2009;9(14):1–8.Google Scholar
  43. 43.
    Vessal G, Mardani Z, Mollai M. Knowledge, attitudes, and perceptions of pharmacists to adverse drug reaction reporting in Iran. Pharm World Sci. 2009;31(2):183–7.CrossRefPubMedGoogle Scholar
  44. 44.
    Weingart SN, Massagli M, Cyrulik A, Isaac T, Morway L, Sands DZ, Weissman JS. Assessing the value of electronic prescribing in ambulatory care: a focus group study. Int J Med Inform. 2009;78(9):571–8.CrossRefPubMedGoogle Scholar
  45. 45.
    Kozamernik B. Spontaneous adverse drug reaction reporting: attitudes and practice of health care professionals and distributors in South East European region. Farm Vestn. 2010;61:271–81.Google Scholar
  46. 46.
    Ting KN, Stratton-Powell DM, Anderson C. Community pharmacists’ views on adverse drug reactions reporting in Malaysia: a pilot study. Pharm World Sci. 2010;32(3):339–42.CrossRefPubMedGoogle Scholar
  47. 47.
    Tobaiqy M, Stewart D, Helms PJ, Bond CM, Lee AJ, McLay J. Views of parents and pharmacists following participation in a paediatric pharmacovigilance study. Pharm World Sci. 2010;32(3):334–8.CrossRefPubMedGoogle Scholar
  48. 48.
    Gavaza P, Brown CM, Lawson KA, Rascati KL, Wilson JP, Steinhardt M. Examination of pharmacists’ intention to report serious adverse drug events (ADEs) to the FDA using the theory of planned behavior. Res Soc Admin Pharm. 2011;7(4):369–82.CrossRefGoogle Scholar
  49. 49.
    Gavaza P, Brown CM, Lawson KA, Rascati KL, Steinhardt M, Wilson JP. Effect of social influences on pharmacists’ intention to report adverse drug events. J Am Pharm Assoc. 2012;52(5):622–9.CrossRefGoogle Scholar
  50. 50.
    Gavaza P, Brown CM, Lawson KA, Rascati KL, Steinhardt M, Wilson JP. Pharmacist reporting of serious adverse drug events to the Food and Drug Administration. J Am Pharm Assoc. 2012;52(5):109–12.CrossRefGoogle Scholar
  51. 51.
    Oosterhuis I, Hunsef FPAM, Puijenbroek EP. Expectations for feedback in adverse drug reporting by healthcare professionals in the Netherlands. Drug Saf. 2012;35(3):221–32.PubMedGoogle Scholar
  52. 52.
    Santosh KC, Tragulpiankit P, Gorsanan S, Edwards IR. Attitudes among healthcare professionals to the reporting of adverse drug reactions in Nepal. BMC Pharmacol Toxicol. 2013;14(16):1–7.Google Scholar
  53. 53.
    Sanghavi DR, Dhande PP, Pandit VA. Perception of pharmacovigilance among doctors in a tertiary care hospital: influence of an interventional lecture. Int J Risk Saf Med. 2013;25(4):197–204.PubMedGoogle Scholar
  54. 54.
    Elkalmi RM, Hassali MA, Ibrahim MI, Jamshed SQ, Al-Lela OQ. Community pharmacists’ attitudes, perceptions, and barriers toward adverse drug reaction reporting in Malaysia: a quantitative insight. J Patient Saf. 2014;10(2):81–7.CrossRefPubMedGoogle Scholar
  55. 55.
    Al-Arifi MN, Mayet AY, Wajid S, Al-Saadi M, Babelghaith AEMISD, Al Ayoubi FZ. Knowledge, attitude and perception of physicians towards adverse drug reaction reporting at King Khalid University Hospital, Riyadh, Saudi Arabia. Trop J Pharm Res. 2015;14(5):907–11.CrossRefGoogle Scholar
  56. 56.
    Inman WHW. Assessment drug safety problems. In: Gent M, Shigmatsu I, editors. Epidemiological issues in reported drug-induced illnesses. Honolulu: McMaster University Library Press; 1976. p. 17–24.Google Scholar
  57. 57.
    Varallo FR, Guimarães SOP, Abjaude SAR, Mastroianni PC. Causes for the underreporting of adverse drug events by health professionals: a systematic review. Rev Esc Enferm USP. 2014;48(4):739–47.CrossRefPubMedGoogle Scholar
  58. 58.
    Gonzalez-Gonzalez C, Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Strategies to improve adverse drug reaction reporting: a critical and systematic review. Drug Saf. 2013;36(5):317–28.CrossRefPubMedGoogle Scholar
  59. 59.
    Pagotto C, Varallo FR, Mastroianni PC. Impact of educational interventions on adverse drug events reporting. Int J Technol Assess Health Care. 2013;29(4):410–41.CrossRefPubMedGoogle Scholar
  60. 60.
    Hopf YM, Bond C, Francis J, Haughney J, Helms PJ. Views of healthcare professionals to linkage of routinely collected healthcare data: a systematic literature review. J Am Med Inform Assoc. 2014;21(e1):e6–10.CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  • Samir Antonio Rodrigues Abjaude
    • 1
  • Stephania Furlanetto Mieli
    • 2
  • Zídia Rocha Magalhães
    • 3
  • Leonardo Régis Leira Pereira
    • 4
    Email author
  1. 1.School of Pharmaceutical Sciences of Ribeirão PretoUniversity of São PauloRibeirão PretoBrazil
  2. 2.Activa-CROSão PauloBrazil
  3. 3.School of NursingUniversidade Federal de Minas GeraisBelo HorizonteBrazil
  4. 4.Pharmaceutical Assistance and Clinical Pharmacy Research Center, Department of Pharmaceutical Sciences, School of Pharmaceutical Sciences of Ribeirão PretoUniversity of São Paulo (USP)Ribeirão PretoBrazil

Personalised recommendations