Analysis of the notifications of adverse drug events in a Brazilian public hospital

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DOI:

https://doi.org/10.30968/rbfhss.2024.154.1208

Abstract

Objective: to describe the adverse drug events (ADE) reported to the Brazilian Health Regulatory Agency (Anvisa) by a public hospital of the Sentinel Network in Belo Horizonte. Method: descriptive observational study, with analysis of the complete ADE notifications registered at VigiMed by the Permanent Committee for Hospital Sanitary Risk Management from January 2021 to May 2022. The notified ADEs were described according to their distribution by month, by sector and according to their classification as adverse drug reaction (ADR) or medication error. The drugs involved in the notifications were classified according to the first level of the Anatomical Therapeutic Chemical (ATC) code from World Health Organization. Results: 74 notifications were analyzed, with a median of five notifications each month. Of those, 14 (18.9%) were ADR; seven (9.4%) were prescription errors; 11 (14.9%) were dispensing errors and 42 (56.8%) were administration errors. The sectors with the highest number of notifications were adult ward - inpatient, oncology - outpatient and pharmacy units. The class of drugs most involved in ADE was “Blood and Blood-forming Organs” (20.3%), followed by “Anti-infectives for systemic use” (18.9%). Conclusion: In this study, the ADEs notified to Anvisa at a public hospital of the Sentinel Network of Belo Horizonte were described qualitatively and quantitatively. Most of the ADEs were drug administration errors and there was a reduced number of ADR notifications. The analysis of these notifications can help the institution with the implementation of preventive and corrective measures to improve the safety in the prescription, use and administration of medicines. It is important to encourage the notification culture to better understand the profile of errors related to the drug chain and act effectively to reduce them.

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References

WHO. Global burden of preventable medication-related harm in health care: a systematic review. World Health Organization; 2023. Disponível em: https://www.who.int/publications/i/item/9789240088887. Acesso em: 25 set. 2024.

Anacleto TA, Rosa MB, Neiva HM, Martins MAP. Erros de medicação: farmácia hospitalar. Conselho Federal de Farmácia, Comissão Farmácia Hospitalar, Encarte de Pharmacia Brasileira; 2010. Disponível em: http://www.sbrafh.org.br/site/index/library/id/53. Acesso em: 25 set. 2024.

Assunção-Costa L, Costa de Sousa I, Alves de Oliveira MR, et al. Drug administration errors in Latin America: A systematic review. PLoS One. 2022;17(8):e0272123. doi: 10.1371/journal.pone.0272123.

Martins AC, Giordani F, Guaraldo L, et al. Adverse drug events identified in hospitalized patients in Brazil by International Classification of Diseases (ICD-10) code listings. Cad Saude Publica. 2018;34(12):e00222417. DOI: 10.1590/0102-311X00222417.

BRASIL. MINISTÉRIO DA SAÚDE. Resolução Nº 872, de 17 de maio de 2024. Dispõe sobre a composição e o funcionamento da Rede Sentinela. Disponível em: https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/rede-sentinela. Acesso em: 25 set. 2024.

BRASIL. ANVISA. Boletim de Farmacovigilância número 8. Erros de Medicação. 2019. Disponível em: https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/monitoramento/farmacovigilancia/boletins-de-farmacovigilancia/boletim-de-farmacovigilancia-no-08.pdf/view. Acesso em: 25 set. 2024.

BRASIL. ANVISA. Boletim de Farmacovigilância número 12. Requisitos da OMS para um Sistema Nacional de Farmacovigilância Funcional. 2020. Disponível em: https://www.gov.

br/anvisa/pt-br/centraisdeconteudo/publicacoes/monitoramento/

farmacovigilancia/boletins-de-farmacovigilancia/boletim-de-farmacovigilancia-no-12.pdf/view. Acesso em: 25 set. 2024.

INTERNATIONAL PHARMACEUTICAL FEDERATION (FIP). Statement of policy the role of the pharmacist in pharmacovigilance. Disponível em: https://www.fip.org/file/1464#:~:-

text=Against%20this%20background%2C%20FIP%20asserts,pharmacovigilance%20programmes%2C%20and%20recommends%20that %3A&text=Pharmacist%20practitioners%20%E2%80%A2%20should%20understand ,the%20safe%20use%20of%20medicines. Acesso em: 08 dez. 2024.

IPSEMG- Instituto de Previdência dos Servidores do Estado de Minas Gerais, Unidades Administrativas. Disponível em: http://www.ipsemg.mg.gov.br/ipsemg/portal/c/site/institucional/551-unidades- administrativas/1814-hospital-governador-israel-pinheiro-hgip/517/561. Acesso em 02 fev. 2022.

WHO Collaborating Centre for Drug Statistics Methodology, ATC classification index with DDD; 2023. Disponível em: https://www.whocc.no/atc_ddd_index/. Acesso em: 24 set. 2023.

Shalviri G, Mohebbi N, Mirbaha F, et al. Improving adverse drug event reporting by healthcare professionals. Cochrane Database Syst Rev. 2024;10(10):CD012594. DOI: 10.1002/14651858.CD012594.pub2.

Fanikos J, Tawfik Y, Almheiri D, et al. Anticoagulation-Associated Adverse Drug Events in Hospitalized Patients Across Two Time Periods. Am J Med. 2023;136(9):927-936.e3. DOI: 10.1016/j.amjmed.2023.05.013.

Zavaleta-Monestel E, Martínez-Rodríguez AR, Rojas-Chinchilla C, et al. Improving medication safety in a Latin American hospital: Examination of medication errors and the role of pharmacists. Am J Health Syst Pharm. 2024; 29:zxae257. DOI: 10.1093/ajhp/zxae257.

BRASIL. ANVISA. Notificações de farmacovigilância; 2021. Disponível em: https://www.gov.br/anvisa/pt-br/acessoainformacao/dadosabertos/informacoes-analiticas/notificacoes-de-farmacovigilancia. Acesso em: 02 nov. 2023.

Silveira GB, Santos CO, Camargo AL. Medication safety incidents: characterization of voluntary reports in an oncology hospital in Porto Alegre. Rev Bras Farm Hosp Serv Saude. 2022;13(1):0730. DOI: 10.30968/rbfhss.2022.131.0730

Ekici Z, Kurutkan MN, Ekici MA. Application of Global Trigger Tools in University Hospital and Comparison to Volunteer Adverse Events Reporting System. Clin Lab. 2024;70(2). DOI: 10.7754/Clin.Lab.2023.230641.

Paiva MCMS, Popim RC, Melleiro MM, et al. The reasons of the nursing staff to notify adverse events. Rev Latino-Am Enfermagem. 2014;22(5):747-754. DOI: 10.1590/0104-1169.3556.2476.

Pereira LC, Nogueira TA, Barbosa LAO, et al. Adverse reactions to docetaxel: an active survey. Braz J Pharm Sci. 2015;51(3):551-559. DOI: 10.1590/S1984-82502015000300007.

Saedder EA, Brock B, Nielsen LP, et al. Identifying high-risk medication: a systematic literature review. Eur J Clin Pharmacol. 2014;70(6):637–645. DOI: 10.1007/s00228-014-1668-z.

Melo JRR, Duarte EC, Ferreira KA, et al. Under-reporting of Adverse Drug Reactions among Healthcare Professionals in Brazil: An Estimate Based on National Pharmacovigilance Survey. J Young Pharm. 2020;12:360-5.

García-Abeijon P, Costa C, Taracido M, et al. Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update. Drug Saf. 2023; 46:625 - 636. DOI: 10.1007/s40264-023-01302-7.

Samsiah A, Othman N, Jamshed S, et al. Knowledge, perceived barriers and facilitators of medication error reporting: a quantitative survey in Malaysian primary care clinics. Int J Clin Pharm. 2020;42(4):1118-1127. DOI: 10.1007/s11096-020-01041-0.

Silva AEBC, Reis AMM, Miasso AI, et al. Adverse drug events in a sentinel hospital in the State of Goiás, Brazil. Rev Latino-Am Enfermagem. 2011;19(2):378–386. DOI: 10.1590/S0104-11692011000200021.

Volpe CRG, Pinho DLM, Stival MM, et al. Medication errors in a public hospital in Brazil. Br J Nurs. 2014;23(11):552–559. DOI:10.12968/bjon.2014.23.11.552.

Alghamdi AA, Keers RN, Sutherland A, et al. Prevalence and Nature of Medication Errors and Preventable Adverse Drug Events in Paediatric and Neonatal Intensive Care Settings: A Systematic Review. Drug Saf. 2019;42(12):1423-1436. DOI: 10.1007/s40264-019-00856-9.

Nanji KC, Patel A, Shaikh S, et al. Evaluation of Perioperative Medication Errors and Adverse Drug Events. Anesthesiology. 2016;124(1):25-34. DOI: 10.1097/ALN.0000000000000904.

Arabyat RM, Martinez AS, Nusair MB. Adverse drug event reporting by pharmacists: a systematic literature review, J Pharm Health Serv Res. 2020;11(1):5–23. DOI: 10.1111/jphs.12332

Vilela RPB, Jericó MC. Implementing technologies to prevent medication errors at a high-complexity hospital: analysis of cost and results. Einstein. 2019;17(4): eGS4621. DOI: 10.31744/einstein_journal/2019GS4621.

Prgomet M, Li L, Niazkhani Z, et al. Impact of commercial computerized provider order entry (CPOE) and clinical decision support systems (CDSSs) on medication errors, length of stay, and mortality in intensive care units: a systematic review and meta-analysis. J Am Med Inform Assoc. 2017;24(2):413-422. DOI: 10.1093/jamia/ocw145.

WHO. Medication Without Harm - Global Patient Safety Challenge on Medication Safety. World Health Organization; 2017. Disponível em: https://iris.who.int/bitstream/handle/10665/255263/WHO-HIS-SDS-2017.6-eng.pdf?sequence=1. Acesso em: 25 set. 2024.

BRASIL. Metas Internacionais de Segurança do Paciente. Empresa Brasileira de Serviços Hospitalares; 2021. Disponível em: https://www.gov.br/ebserh/pt-br/hospitais-universitarios/regiao-sudeste/hc-ufmg/saude/metas-internacionais-de-seguranca-do-paciente/metas-internacionais-de-seguranca-do-paciente. Acesso em: 03 nov. 2023.

Published

2024-12-30

How to Cite

1.
SANTOS LD, MORAES HM, FERREIRA CL, RODRIGUES GG, NASCIMENTO MG, BERTOLLO CM. Analysis of the notifications of adverse drug events in a Brazilian public hospital. Rev Bras Farm Hosp Serv Saude [Internet]. 2024Dec.30 [cited 2025Jan.6];15(4):e1208. Available from: https://rbfhss.org.br/sbrafh/article/view/1208

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