SciELO - Scientific Electronic Library Online

vol.48 issue4Virtual Environment: assistance in nursing care for the deaf based on the protocol of Primary CarePerceived self-image in adolescent idiopathic scoliosis: an integrative review of the literature author indexsubject indexarticles search
Home Pagealphabetic serial listing  

Services on Demand




Related links


Revista da Escola de Enfermagem da USP

Print version ISSN 0080-6234

Rev. esc. enferm. USP vol.48 no.4 São Paulo Aug. 2014 

Critical Review

Causes for the underreporting of adverse drug events by health professionals: a systematic review

Causas de subnotificação de eventos adversos a medicamentos por profissionais da saúde: revisão sistemática

Fabiana Rossi Varallo1 

Synara de Oliveira Paim Guimarães2 

Samir Antonio Rodrigues Abjaude3 

Patricia de Carvalho Mastroianni4 

1PhD Student in Pharmaceutical Sciences, Faculty of Pharmaceutical Sciences, São Paulo State University “Júlio de Mesquita Filho”, Araraquara, SP, Brazil

2Pharmacist Specialized in Public Health, Faculty of Pharmaceutical Sciences, São Paulo State University “Júlio de Mesquita Filho”, Araraquara, SP, Brazil

3Master Student in Pharmaceutical Sciences, Faculty of Pharmaceutical Sciences, São Paulo State University “Júlio de Mesquita Filho”, Araraquara, SP, Brazil

4Professor, PhD, Faculty of Pharmaceutical Sciences, São Paulo State University “Júlio de Mesquita Filho”, Araraquara, SP, Brazil


Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR) by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed in the period between 1992 and 2012. Descriptors were used in the search for articles, and the identified causes of underreporting were analyzed according to the classification of Inman. Results: In total, were identified 149 articles, among which 29 were selected. Most studies were carried out in hospitals (24/29) for physicians (22/29), and pharmacists (10/29). The main causes related to underreporting were ignorance (24/29), insecurity (24/29) and indifference (23/29). Conclusion: The data show the eighth sin in underreporting, which is the lack of training in pharmacovigilance. Therefore, continuing education can increase adherence of professionals to the service and improve knowledge and communication of risks due to drug use.

Key words: Adverse Drug Reaction Reporting Systems; Health personnel; Pharmacovigilance; Product surveillance, postmarketing; Education, continuing; Review


Objetivo: Identificar as causas de subnotificação de Reação Adversa a Medicamento (RAM) por profissionais da saúde. Método: Revisão sistemática realizada nas bases de dados LILACS, PAHO, SciELO, EMBASE e PubMed, cujo período de abrangência foi de 1992 a 2012. Foram utilizados descritores para buscar os artigos. As causas de subnotificação de RAM identificadas foram analisadas de acordo com a classificação de Inman. Resultados: Identificaram-se 149 artigos, dos quais 29 foram considerados elegíveis. A maioria dos estudos foi conduzida em hospitais (24/29), para médicos (22/29) e farmacêuticos (10/29). As principais causas relacionadas à subnotificação observadas foram: a ignorância (24/29), a insegurança (24/29) e a indiferença (23/29). Conclusão: Os dados evidenciam o oitavo pecado da subnotificação, que é a falta de formação em farmacovigilância. Assim, a educação permanente pode aumentar a adesão dos profissionais ao serviço e melhorar o conhecimento e a comunicação dos riscos associados ao uso de medicamentos.

Palavras-Chave: Sistemas de Notificação de Reações Adversas a Medicamentos; Pessoal de saúde; Farmacovigilância; Vigilância de produtos comercializados; Educação continuada; Revisão


Objetivo: Identificar las causas de la subnotificación de la Reacción Adversa a Medicamento (RAM) por profesionales de la salud. Método: Revisión sistemática realizada en las bases de datos LILACS, PAHO, SciELO, EMBASE y PubMed, cuyo período de revisión fue de 1992 a 2012. Se utilizaron descriptores para buscar los artículos. Las causas de subnotificación identificadas fueron analizadas de acuerdo con la clasificación de Inman. Resultados: Se identificaron 149 artículos, de los cuales 29 fueron seleccionados. La mayoría de los estudios fueron realizados en hospitales (24/29) para médicos (22/29) y farmacéuticos (10/29). Las principales causas relacionadas a la subnotificación observadas fueron: la ignorancia (24/29), la inseguridad (24/29) y la indiferencia (23/29). Conclusión: Los datos evidencian el octavo pecado de la subnotificación, que es la falta de formación en farmacovigilancia. Por lo tanto, la educación continua puede aumentar la adhesión de los profesionales al servicio y mejorar el conocimiento y la comunicación de riesgos del uso de medicamentos.

Palabras-clave: Sistemas de Registro de Reacción Adversa a Medicamentos; Personal de la salud; Farmacovigilancia; Vigilancia de Productos Comercializados; Educación continua; Revisión


Spontaneous reporting of adverse drug events (ADEs) comprise the primary method for detecting signs in pharmacovigilance, because they are effective for identifying serious unexpected adverse drug reactions (ADRs), medication errors, therapeutic ineffectiveness and inconsistencies in drug quality, besides its low cost(1).

It is estimated that between 5% and 10% of ADR are reported(2-4). Thus, the main limitation of the passive method of analysis of drug safety is cases underreporting(5), which decreases the sensitivity for detecting ADE, making it difficult to estimate the frequency of occurrence, as well as assessing the severity and impact on the health of drug users(6).

For improving the voluntary adhesion of health professionals in the assessment of drug safety, and to increase rates of ADR reporting, some actions are necessary. It is important to identify the causes that lead to underreporting of problems related to the use of drugs by health professionals, in order to establish strategies that will be developed for encouraging the communication of risks associated with drug use and provide safety guarantees for patients. In this context, the objectives of this study were: 1) identifying the manuscripts that analyzed the causes associated with poor adherence of health professionals to the passive method of pharmacovigilance service and, 2) proposing strategies designed to improve the rates of spontaneous reporting of ADR.


The systematic review was carried out in the databases of LILACS, PAHO, SciELO, EMBASE and PubMed, looking for items to answer the guiding question: What causes that health professionals do not realize the pharmacovigilance notification?

The search strategy used was based on the PRISMA Statment(7), using the following health descriptors: Surveillance of Marketed Products AND Adverse Drug Reaction Reporting Systems AND Attitude of Health Staff. The following keywords were also used to complement the search: ADR, underreporting of ADRs, notification rate of ADRs, adverse drug reactions (ADRs), under-reporting of ADRs and attitudes and reporting behavior.

The technique of content analysis was used for selecting the articles(8). The initial reading of all articles identified by the elaborate search technique was done (N=149), covering the period between 1992 and 2012. The goal was to eliminate the articles that were not in English, Portuguese or Spanish; unavailable manuscripts; reviews; educational interventions; editorials; letters to the editor; news; comments; as well as results that were dissertations, thesis or abstracts published in conference proceedings or scientific journals.

The selected articles were subjected to content analysis and those not assessing the causes related to the underreporting of ADR by health professionals were eliminated. The analysis of the articles were developed by two reviewers (FRV and SGP), with eventual disagreements resolved through discussion.

The variables of interest were defined through a content analysis involving the following criteria: year of publication, country in which the study was carried out, the study method (epidemiological approach), instruments and methodology used for assessing the cause of underreporting, level of health care, professional category included in the study, adherence to the survey (response of professionals participating in the study), and the causes of underreporting according to the criteria described by Inman WHW(9). He was the first to present a list of seven attitudes related to the causes of underreporting, calling them the seven deadly sins:

  1. complacency (believing that serious ADRs are well documented when the drug is released in the market);

  2. fear of getting involved in a lawsuit (legal process);

  3. guilt for having been responsible for the damage observed in the patient;

  4. ambition of group and publish case series or financial benefit;

  5. ignorance on how to describe the notification (believing that only serious and unexpected ADRs must be reported);

  6. insecurity about reporting suspicions of ADR (belief that there should be notification only if there is certainty that the damage was caused by the use of specific medication);

  7. indifference, that is, lack of interest, time or other excuses related to postponing the notification of damage due to drug use.


In total, 149 potentially relevant articles were identified on the evaluated database. After reading the abstracts, 117 articles were eliminated for not fitting the inclusion criteria. After content analysis, four articles were eliminated (Chart 1) and 29 were considered eligible for the study (Chart 2).

Chart 1 Studies excluded of the review after content analysis and rationale for not meeting the inclusion criteria 

Chart 2 Studies that analyzed the causes related to underreporting of adverse drug events 

It was observed that most of the studies (N=16) were carried out in the European continent, especially at tertiary level of health care (N=24) for physicians (N=22) and pharmacists (N=10). The experimental method most widely used for identifying the causes was the cross-sectional, observational (N=24), with the questionnaire as the most used instrument (N=26). The response rate of the study subjects was greater than 50% in 21 studies, although three studies did not report these data. The main causes related to underreporting of adverse drug reaction were ignorance (N=24), insecurity (N=24) and indifference (N=23). No causes different than those established by Inman WHW have been identified(9). However, the data show the eighth sin of underreporting, which is the lack of training in pharmacovigilance.


The pharmacovigilance underreporting is a global reality evidenced by the identified studies, which were carried out in 17 different countries, and a multicenter study conducted in the European Union. However, it was observed that most of the analyzed publications (N = 17) were carried out in Europe (Germany, Spain, Holland, England, Ireland, Italy, Portugal, UK, Sweden). Such fact can be explained based on the tradition of these countries in the Program for International Drug Monitoring of the World Health Organization. In 1968, due to the presence of national ADR registration systems in Ireland, Holland, Sweden and the UK, these nations were invited to send ADR records for the WHO, in order to assess the safety of drugs available in the pharmaceutical market(43).

However, most of the countries in America, Africa and Asia joined the program afterwards (in the 1990s and 2000), which leads to the assumption that pharmacovigilance activities are more recent hence, only few studies were identified. For this reason, there is a need to better understand the factors associated with underreporting of problems related to drug use, and encourage voluntary reports by health professionals in these countries or Latin American countries.

The main epidemiological method and technique of data collection verified in this review was the cross-sectional, observational study (N = 24), and use of self-reported questionnaires (N = 15). These are relevant strategies to encourage surveys of this nature, especially in developing countries such as those from Latin America, where only one study was identified. This is justified based on the benefits of cross-sectional studies, which are inexpensive, can be made in a short time frame, and are capable of creating research hypotheses to be investigated with more robust methodologies. Moreover, the identified papers that used this method obtained similar results in relation to the authors who carried out studies with larger level of evidence (case-control). A study(44) carried out the analysis of the characteristics of ADR recorded in the WHO-ADR database (Vigibase), correlating this information with the income profile of registrars countries. The authors found that the rates of notification are lower in low-income countries, probably due to lack of knowledge and experience(11,13). This corroborates the necessity of encouraging studies in these countries with the use of cheaper methods.

Considering the application of self-reported questionnaires, the literature points the low rate of return of these instruments by study participants (mostly doctors) as the main limitation of this technique(45). The loss of more than 20% of the sample hampers conclusions with data for other populations, in addition to other factors such as convenience and sample size, method of study and biased results, considering that professionals who voluntarily answered the questionnaire possibly showed greater interest in the area of pharmacovigilance. However, the application of questionnaire by mail or email facilitates data collection, especially when respondents are geographically spread. Given this, a search(46) proposed sending stamps for the responses and reminders of the return period to encourage subjects’ adherence to the survey.

Despite the limitations of collection methods and techniques, the main causes of ADR underreporting found in the included studies were ignorance and insecurity. This has a strong correlation with professionals’ low knowledge about the activities of analysis of drug safety. Such fact was the most common cause for non-adherence of professionals to pharmacovigilance service, confirming a study hypothesis that evaluated the condition of notifications.

Thus, the notifications of professionals may be encouraged by promoting educational interventions aimed at clarifying the importance of the practice. As well as the concepts and processes involved in these activities, namely: which ones should be recorded (any suspected adverse drug events), who can register, and the return to society (patient safety), health facilities (reduction of unnecessary costs) and the pharmaceutical market (control and regulation). Studies show that continuing education for health professionals are effective in changing attitudes and behavior in relation to registration of adverse drug events, notably ADR(47-48). Hence, economic costs are optimized due to the incentive on rates of voluntary registration of ADR(20).

Another cause of underreporting frequently reported by physicians and pharmacists included in the study is indifference, mainly associated with the lack of interest in registration, lack of time for too many activities in the clinical routine, among others. As an attempt to solve this problem, the ADR reporting by the own users of drugs is a positive perspective(49). In addition, making the access to registration forms easier and simplifying documents(1), would contribute to improve the notification rates of problems related to medication, as well as facilitating communication between registrars and pharmacovigilance centers (such as the Rede Sentinela, a project developed in Brazil that encourages pharmacovigilance activities in hospitals, aimed at enabling the analysis of safety, quality and effectiveness of medicines), and encouraging feedback from the results of reports (26,31,35).

Studies evaluating the attitudes of nursing staff(24,42) found that the lack of knowledge in completing the notification form, and the lack of time to report ADRs are the main causes of underreporting in this class. Therefore, strategies must be developed to improve the adhesion of these professionals to the pharmacovigilance service. As these professionals are responsible for administering medications and assisting by the bedside, they can contribute to identify suspected problems of safety and effectiveness of drugs(50), especially serious ADR(51) that are unexpected. Thus, the training and qualifications of nursing staff may allow the development of competencies and skills for behavior change in relation to the spontaneous reporting. A study(52) verified that the completion of training by nurses is essential to optimize their roles in pharmacovigilance actions. In addition, health institutions should strengthen nonpunitive management for the administration of risks associated with drug therapy.

Health institutions are changing the way they manage risk (from personal to systemic)(53), and encouraging the notification of adverse events to drugs by health professionals, in order to improve processes and not to identify the author, causing fear of punishment and retaliation in these professionals, which is a major barrier to promote the reporting of drug related problems. Thus, ensuring the confidentiality and secrecy of people reporting the data avoids their exposure and encourages their participation in the analysis of drug safety(54).

The great interest in compiling and publishing case series was one of the causes of underreporting less frequently mentioned by professionals, perhaps because this is more related to the interests of researchers associated with universities. However, all records resulting from scientific investigations should not be dissociated from the regulatory acts. Therefore, they should be given to regulatory health agencies for feeding the database, contributing to signal generation in pharmacovigilance and improving communication of the risks associated with drug use. Considering financial benefits, such as encouraging registration of ADR through salary increases or bonuses for example, is a questionable strategy, since no impact of this incentive was found on ADR reporting in a study carried out in a Spanish hospital(55).

Finally, it is necessary to know the causes that lead to non-compliance with pharmacovigilance service in order to strongly encourage the reporting of ADR by health professionals, because many strategies can be used and developed for reducing this problem to a minimum. Thus, the best action plan may be designed, considering the needs and aspirations of the people who report the cases, the available resources for strategies implementation and the frequency with which they should applied. Therefore, studies of this nature should be carried out primarily in the American continent to indirectly contribute with the harmonization of patient safety plans.

Finally, the underreporting causes often informed by health professionals are related mainly to the low knowledge of concepts and processes related to pharmacovigilance and to indifference regarding this service. Continuing education, easy access to the registration form and its simplification are strategies that can be developed to increase the registration rates of ADR by health professionals. Furthermore, low cost epidemiological methods (cross-sectional, observational type) are able to detect similar underreporting causes when compared with methods of higher levels of evidence. This allows that developing countries like those of Latin America carry out studies aimed at investigating the reasons associated with low adherence of health professionals to pharmacovigilance service and demystify prejudices about the consequences of underreporting.

The limitation of the study was that the data obtained may be underestimated because of the selection strategy. Five databases were consulted and the only articles considered eligible were those written in Portuguese, English and Spanish, plus eight articles not available to consultation, which were then eliminated from the review. In addition to that, every author had an own interpretation of the seven sins of Inman, which can have been different from those considered in this review.


This study allowed adding the eighth deadly sin in underreporting: the lack of training in pharmacovigilance for health professionals. However, qualitative studies are needed to better understand this phenomenon.


1.Organización Panamericana de la Salud; Grupo de Trabajo en Farmacovigilancia. Buenas prácticas de farmacovigilancia para las Américas. Washington; 2010 [ Links ]

2.Cullen DJ, Bates DW, Small SD, Cooper JB, Nemeskal AR, Leape LL, et al. The incident reporting system does not detect adverse drug events: a problem for quality improvement. Jt Comm J Qual Improv. 1995;21(10):541-8 [ Links ]

3.Hazell L, Shaki SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385-6 [ Links ]

4.Romero AV, Malone DC. Accuracy of adverse­drug­event reports collected using an automated dispensing system. Am J Health Syst Pharm. 2005;62(13):1375­80 [ Links ]

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 [ Links ]

6.Biagi C, Montanaro N, Buccellato E, Roberto G, Vaccheri A, Motola D, et al. Under-reporting in pharmacovigilance: an intervention for Italian GPs (Emilia-Romagna region).Eur J Clin Pharmacol. 2013;69(2):237-44 [ Links ]

1.Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol. 2009;62(10):1006-12 [ Links ]

8.Bardin L. Análise de conteúdo. Lisboa: Edições 70; 1977 [ Links ]

9.Inman WHW. Assessment drug safety problems. In: Gent M, Shigmatsu I, editors. Epidemiological issues in reported drug-induced illnesses. Honolulu, Ontario: McMaster University Library Press; 1976. p. 17-24 [ Links ]

10.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(5):381-5 [ Links ]

11.Granas AG, Buajordet M, Sterberg-Nilsen H, Harg P, Horn AM. Pharmacists’ attitudes towards the reporting of suspected adverse drug reactions in Norway. Pharmacoepidemiol. Drug Saf. 2007;16(4):429-34 [ Links ]

12.Matamoros P, Alvarez-Diaz MM, Ramos-Acetero JM. Role of nurses from Extremadura in the Spanish drug surveillance system (2000-2005). Enferm Clin. 2007;17(6):318-21 [ Links ]

13.González‐Rubio F, Calderón‐Larrañaga A, Poblador-Plou B, Navarro‐Pemán C, López‐Cabañas A, Prados‐Torres, et al. Under-reporting of recognized adverse drug reactions by primary care physicians: an exploratory study. Pharmacoepidemiol Drug Saf. 2011;20(12):1287-94 [ Links ]

14.Bateman DN, Sander GLS, Rawlins MD. Attitudes to adverse drug reaction reporting in the Northern Region. Br J Clin Pharmacol. 1992;34(5):421-6 [ Links ]

15.Belton KJ, Lewis SC, Payne S, Rawlins MD, Wood SM. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Br J Clin Pharmacol. 1995;39(3):223-6 [ Links ]

16.Belton KJ; European Pharmacovigilance Research Group. Attitude survey of adverse drug- reaction reporting by health care professionals across the European Union. Eur J Clin Pharmacol. 1997;52(6):423-7 [ Links ]

17.Cosentino M, Leoni O, Banfi F, Lecchini S, Frigo G. Attitudes to adverse drug reaction reporting by medical practitioners in Northern Italian district. Pharmacol Res. 1997;35(2):85-8 [ Links ]

18.Eland IA, Belton KJ, Grootheest AP, Meiners AP, Rawlins MD, Stricker BH. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol. 1999; 48(4):623-7 [ Links ]

19.Williams D, Feely J. Under-reporting of adverse drug reactions: attitudes of Irish doctors. Ir J Med Sci. 1999;168(4):257-61 [ Links ]

20.Bäckström M, Mjörndal T, Dahlqvist R, Nordkvist-Olsson T. Attitudes to reporting adverse drug reactions in northern Sweden. Eur J Clin Pharmacol. 2000;56(9-10):729-32 [ Links ]

21.Figueiras A, Tato F, Fontaiñas J, Takkouche B, Gestal-Otero JJ. Physicans’ attitudes towards voluntary reporting of adverse drug events. J Eval Clin Pract. 2001;7(4):347-54 [ Links ]

22.Green CF, Mottram DR, Rowe PH, Pirmohamed M. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol. 2001;51(1):81-6 [ Links ]

23.Hasford J, Goettler M, Munter-Oerlinghausen B. Physicans’ knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol. 2002;55(9):945-50 [ Links ]

24.Li Q, Zhang SM, Chen HT, Fang SP, Yu X, Liu D, et al. Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions. Chin Med J. 2004;117(6):856-61 [ Links ]

25.Herdeiro MT, Figueiras A, Polónia J, Gestal-Otero JJ. Pysicans’ attitudes and adverse drug reaction reporting: a case-control study in Portugal. Drug Saf. 2005;28(9):825-83 [ Links ]

26.Vallano A, Cereza G, Pedròs C, Agustí A, Danés I, Aguilera C, et al. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital. Br J Clin. Pharmacol. 2005;60(6):653-8 [ Links ]

27.Herdeiro MT, Figueiras A, Polónia J, Gestal-Otero JJ. Influence of pharmacists’ attitudes on adverse drug reaction reporting: a case- control study in Portugal. Drug Saf. 2006;29(4):331-40 [ Links ]

28.Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: predictors of under-reporting in Malaysia. Pharmacoepidemiol. Drug Saf. 2007;16(2):223-8 [ Links ]

29.Okezie EO, Olufunmilayo F. Adverse drug reactions reporting by physicans in Ibadan, Nigeria. Pharmacoepidemiol. Drug Saf. 2008;17(5):517-22 [ Links ]

30.Ekman E, Bäckström M. Attitudes among hospital physicans to the reporting of adverse drug reactions in Sweden. Eur J Clin Pharmacol. 2009;65(1):43-6 [ Links ]

31.Nichols V, Thériault-Dubé I, Touzin J, Delisle JF, Lebel D, Bussières JF, et al. Risk perception and reasons for noncompliance in pharmacovigilance: a qualitative study conducted in Canadá. Drug Saf. 2009;32(7):579-90 [ Links ]

32.Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigéria. BMC Clin Pharmacol. 2009;9:14 [ Links ]

33.Passier A, Napel M, 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 [ Links ]

34.Vessal G, Mardani Z, Mollai M. Knowledge, attitudes, and perceptions of pharmacists to adverse drug reaction reporting in Iran. Pharm. World Sci. 2008;31(2):183-7 [ Links ]

35.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(5):651-7 [ Links ]

36.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 [ Links ]

37.Bello SO, Umar MT. Knowledge and attitudes of physicans relating of adverse drug reactions in Sokoto, north- western Nigéria. Ann Afr Med. 2011;10(1):13-8 [ Links ]

38.Desai CK, Iyey G, Panchal J, Shah S, Dikshit RK. An evalution of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital. Perspect Clin Res. 2011;2(4):129-36 [ Links ]

39.Gravaza 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 [ Links ]

40.Oreagba IA, Ogunleye OJ, Olayemi SO. The knowledge, perceptions and practice of pharmacovigilance amongst community pharmacists in Lagos state, south west Nigeria. Pharmacoepidemiol Drug Saf. 2011;20(1):30-5 [ Links ]

41.García MP, Figueras A. The lack of knowledge about the voluntary reporting system of adverse drug reactions as a major cause of under-reporting: direct survey among health professionals. Pharmacoepidemiol Drug Saf. 2011;20(12):1295-305 [ Links ]

42.Pernas SIS, Herdeiro MT, Lopez-Gonzalez E, da Cruz e Silva OA, Figueiras A. Attitudes of Portuguese health professionals toward adverse drug reaction reporting. Int J Clin Pharm. 2012;34(5):693-8 [ Links ]

43.World Health Organization. WHO Programme for International Drug Monitoring [Internet]. Geneva; 2013 [cited 2013 Nov 18]. Available from: [ Links ]

44.Aagaard L, Strandell J, Melskens L, Petersen PS, Holme Hansen E. Global patterns of adverse drug reactions over a decade: analyses of spontaneous reports to VigiBase™. Drug Saf. 2012;35(12):1171-82 [ Links ]

45.Guadagnoli E, Cunningham S. The effects of nonresponse and late response on a survey of physician attitudes. Eval Health Prof. 1989;12(3):318-28 [ Links ]

46.Castro LLC, organizador. Fundamentos de farmacoepidemiologia. 3ª ed. Campo Grande: Vida e Consciência; 2006 [ Links ]

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 [ Links ]

48.Pagotto C, Varallo FR, Mastroianni PC. Impact of educational interventions on adverse drug events reporting. Int J Technol Assess Health Care. 2013;29(4):410-7 [ Links ]

49.Avery AJ, Anderson C, Bond CM, Fortnum H, Gifford A, Hannaford PC, et al. Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess. 2011;15(20):1-234 [ Links ]

50.Conforti A, Opri S, D’Incau P, Sottosanti L, Moretti U, Ferrazin F, et al. Adverse drug reaction reporting by nurses: analysis of Italian pharmacovigilance database. Pharmacoepidemiol Drug Saf. 2012;21(6):597-602 [ Links ]

51.Bäckström M, Ekman E, Mjörndal T. Adverse drug reaction by nurses in Sweden. Eur J Clin Pharmacol. 2007;63(6):613-8 [ Links ]

52.Stewart D, Maclure K, Paudual B, Hughes C, Courtenay M, McLay J. Non-medical prescribers and pharmacovigilance: participation, competence and future need. Int J Clin Pharm. 2013; 35(2):268-74 [ Links ]

53.Reason J. Human error: models and management. BMJ. 2000;320(7237):768-70 [ Links ]

54.Aranaz Andrés JM. Acerca de los sistemas de notificación y registro de sucesos adversos [editorial]. Rev Calidad Asistencial. 2009;24(1):1-2 [ Links ]

55.Pedrós C, Vallano A, Cereza G, Mendoza-Aran G, Agustí A, Aguilera C, et al. An intervention tom improve spontaneous adverse drug reaction reporting by hospital physicians. Drug Saf. 2009;32(1):77-83 [ Links ]

Received: December 02, 2013; Accepted: May 18, 2014

Correspondence: Patrícia de Carvalho Mastroainni. 
Depto de Fármacos e Medicamentos, Fac de Ciências Farmacêuticas. Universidade Estadual Paulista “Júlio de Mesquita Filho”. 
Rodovia Araraquara – Jaú, Km 1 
CEP 14801-902 - Araraquara, SP, Brazil
. E-mail:

Creative Commons License This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.