Factors associated with underreporting of adverse drug reactions by patients: a systematic review

Montané E, Santesmases J. Reacciones adversas a medicamentos. Med Clin. 2020;154(5):178–84.

Article  Google Scholar 

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta- analysis of prospective studies. J Am Med Assoc. 1998;279(15):1200–5.

Article  CAS  Google Scholar 

Bouvy JC, de Bruin ML, Koopmanschap MA. Epidemiology of adverse drug reactions in Europe: a review of recent observational studies. Drug Saf. 2015;38(5):437–53.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Oscanoa TJ, Lizaraso F, Carvajal A. Hospital admissions due to adverse drug reactions in the elderly: a meta-analysis. Eur J Clin Pharmacol. 2017;73(6):759–70.

Article  CAS  PubMed  Google Scholar 

European Comission. Strengthening pharmacovigilance to reduce adverse effects of medicines. Memo/08/782. 2008. Availabe at: https://ec.europa.eu/commission/presscorner/detail/de/MEMO_08_782. Accessed 04 Dec 2021.

Meier F, Maas R, Sonst A, et al. Adverse drug events in patients admitted to an emergency department: an analysis of direct costs. Pharmacoepidemiol Drug Saf. 2015;24(2):176–86.

Article  PubMed  Google Scholar 

Hoonhout LHF, de Bruijne MC, Wagner C, et al. Nature, occurrence and consequences of medication-related adverse events during hospitalization: a retrospective chart review in the Netherlands. Drug Saf. 2010;33(10):853–64.

Article  PubMed  Google Scholar 

Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: authors’ reply. BMJ. 2004;329(7456):15–9.

Article  PubMed  PubMed Central  Google Scholar 

Formica D, Sultana J, Cutroneo PM, et al. The economic burden of preventable adverse drug reactions: a systematic review of observational studies. Expert Opin Drug Saf. 2018;17(7):681–95.

Article  CAS  PubMed  Google Scholar 

Alomar M, Tawfiq AM, Hassan N, et al. Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future. Ther Adv Drug Saf. 2020;11:204209862093859.

Article  Google Scholar 

Härmark L, van Grootheest AC. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol. 2008;64(8):743–52.

Article  PubMed  Google Scholar 

Herxheimer A, Crombag R, Alves TL. Direct patient reporting of adverse drug reactions a fifteen-country survey & literature review. Health Action International (Europe). 2010. Availabe at: https://consumers.cochrane.org/sites/consumers.cochrane.org/files/uploads/10%20May%202010%20Report%20Direct%20Patient%20Reporting%20of%20ADRs.pdf. Accessed 19 Nov 2021.

Valinciute-Jankauskiene A, Kubiliene L. Adverse drug reaction reporting by patients in 12 European countries. Int J Environ Res Public Health. 2021;18(4):1507.

Article  PubMed  PubMed Central  Google Scholar 

European Comission. Regulation (EU) no 1235/2010 of the European Parliament and of the Council. EU. 2010. Available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF. Accessed 08 Nov 2021.

Borg JJ, Aislaitner G, Pirozynski M, et al. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance. Drug Saf. 2011;34(3):187–97.

Article  PubMed  Google Scholar 

Santoro A, Genov G, Spooner A, et al. Promoting and protecting public health: how the European Union pharmacovigilance system works. Drug Saf. 2017;40(10):855–69.

Article  PubMed  PubMed Central  Google Scholar 

Herdeiro MT, Ferreira M, Ribeiro-Vaz I, et al. O sistema Português de farmacovigilância. Acta Med Port. 2012;25(4):241–9.

Article  PubMed  Google Scholar 

Sienkiewicz K, Burzyńska M, Rydlewska-Liszkowska I, et al. The importance of direct patient reporting of adverse drug reactions in the safety monitoring process. Int J Environ Res Public Health. 2022;19(1):413.

Article  CAS  Google Scholar 

Inácio P, Cavaco A, Airaksinen M. The value of patient reporting to the pharmacovigilance system: a systematic review. Br J Clin Pharmacol. 2017;83(2):227–46.

Article  PubMed  Google Scholar 

Rolfes L, van Hunsel F, Wilkes S, et al. Adverse drug reaction reports of patients and healthcare professionals-differences in reported information. Pharmacoepidemiol Drug Saf. 2015;24(2):152–8.

Article  PubMed  Google Scholar 

Inch J, Watson MC, Anakwe-Umeh S. Patient versus healthcare professional spontaneous adverse drug reaction reporting: a systematic review. Drug Saf. 2012;35(10):807–18.

Article  PubMed  Google Scholar 

Avery AJ, Anderson C, Bond CM, 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.

Article  CAS  PubMed  Google Scholar 

Hazell L, Shakir SAW. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385–96.

Article  PubMed  Google Scholar 

Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther. 1998;20(Suppl C):C40–4.

Article  CAS  PubMed  Google Scholar 

European Medicines Agency. EMA Annual Report 2017: The European Medicines Agency’s contribution to science, medicines and health in 2017. Available at: https://www.ema.europa.eu/en/documents/annual-report/2017-annual-report-european-medicines-agency_en.pdf. Accessed 28 Nov 2021.

European Medicines Agency. 2020 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission. European Medicines Agency. Available at: https://www.ema.europa.eu/en/documents/report/2020-annual-report-eudravigilance-european-parliament-council-commission_en.pdf. Accessed 28 Nov 2021.

Banovac M, Candore G, Slattery J, et al. Patient reporting in the EU: analysis of EudraVigilance data. Drug Saf. 2017;40(7):629–45.

Article  PubMed  Google Scholar 

Margraff F, Bertram D. Adverse drug reaction reporting by patients: an overview of fifty countries. Drug Saf. 2014;37(6):409–19.

Article  CAS  PubMed  Google Scholar 

Blenkinsopp A, Wilkie P, Wang M, et al. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol. 2007;63(2):148–56.

Article  CAS  PubMed  Google Scholar 

Al Dweik R, Stacey D, Kohen D, et al. Factors affecting patient reporting of adverse drug reactions: a systematic review. Br J Clin Pharmacol. 2017;83(4):875–83.

Article  PubMed  Google Scholar 

Inman WHW. Attitudes to adverse drug reaction reporting. Br J Clin Pharmacol. 1996;41(5):434–5.

Article  CAS  PubMed  Google Scholar 

Inman WHW, Weber JCT. The United Kingdom. In: Inman WHW, editor. Monitoring for drug safety. 2nd ed. Lancaster: MTP Press Ltd; 1986. pp. 13–47.

Inman WHW. Assessment of drug safety problems. In: Gent M, ShigmatsuI, editors. Epidemiological issues in reported drug-induced illnesses. Honolulu(ON): McMaster University Library Press; 1976. pp. 17–24

Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.

Article  PubMed  PubMed Central  Google Scholar 

Downes MJ, Brennan ML, Williams HC, et al. Development of a critical appraisal tool to assess the quality of cross-sectional studies (AXIS). BMJ Open. 2016;6(12):e011458.

Article  PubMed  PubMed Central  Google Scholar 

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.

Article  CAS  PubMed  Google Scholar 

Wang N, Chen Y, Ren B, et al. A cross-sectional study: comparison of public perceptions of adverse drug reaction reporting and monitoring in eastern and western China. BMC Health Serv Res. 2022;22(1):318.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Januskiene J, Segec A, Slattery J, et al. What are the patients’ and health care professionals’ understanding and behaviors towards adverse drug reaction reporting and additional monitoring? Pharmacoepidemiol Drug Saf. 2021;30(3):334–41.

Article  PubMed  Google Scholar 

Pillay S, Mulubwa M, Viljoen M. Parental reporting of adverse drug reactions in South Africa: an online survey. Afr J Prim Health Care Fam Med. 2021;13(1):e1–8.

Article  PubMed  Google Scholar 

Al Dweik R, Yaya S, Stacey D, et al. Patients’ experiences on adverse drug reactions reporting: a qualitative study. Eur J Clin Pharmacol. 2020;76(12):1723–30.

Article  PubMed  Google Scholar 

Kim S, Yu YM, You M, et al. A cross-sectional survey of knowledge, attitude, and willingness to engage in spontaneous reporting of adverse drug reactions by Korean consumers. BMC Public Health. 2020;20(1):1527.

Article  PubMed  PubMed Central  Google Scholar 

Adisa R, Omitogun TI. Awareness, knowledge, attitude and practice of adverse drug reaction reporting among health workers and patients in selected primary healthcare centres in Ibadan, southwestern Nigeria. BMC Health Serv Res. 2019;19(1):926.

Article  PubMed  PubMed Central  Google Scholar 

Adisa R, Adeniyi OR, Fakeye TO. Knowledge, awareness, perception and reporting of experienced adverse drug reactions among outpatients in Nigeria. Int J Clin Pharm. 2019;41(4):1062–73.

Article  PubMed  Google Scholar 

Jacobs TG, Hilda Ampadu H, Hoekman J, et al. The contribution of Ghanaian patients to the reporting of adverse drug reactions: a quantitative and qualitative study. BMC Public Health. 2018;18(1):1384.

Article  PubMed  PubMed Central  Google Scholar 

Sabblah GT, Darko DM, Mogtari H, et al. Patien

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