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.
Similar content being viewed by others
References
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Gavaza P, Bui B. Pharmacy students’ attitudes toward reporting serious adverse drug events. Am J Pharm Educ. 2012;76(10):194.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Acknowledgements
We thank Marilia Silveira de Almeida Campos for statistical cooperation and revision of the text.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
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.
Electronic supplementary material
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
Abjaude, S.A.R., Mieli, S.F., Magalhães, Z.R. et al. Factors that Motivate Healthcare Professionals to Report Adverse Drug Events: A Systematic Review. Pharm Med 31, 13–20 (2017). https://doi.org/10.1007/s40290-016-0174-2
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40290-016-0174-2