Technical complaints and adverse drug reactions reported in a regional hospital in Brazil: a cross-sectional study

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Alan Maicon de Oliveira
Valéria Albuquerque Vaz Rodrigues
Juliana Petini Passerini
Paula Bercelli Zanoveli Pedreiro
Beatriz Alessi Minto

Abstract

Introduction: Adverse reactions and incidents associated with drugs cause death and threaten patient safety. In Brazil, there is still a shortage of epidemiological data on these episodes and an approach still insufficient. Objective: To describe the frequency and characteristics of reports of technical complaints and adverse drug reactions (ADRs) in a regional hospital. Methods: A cross-sectional study was carried out in a Hospital School in the northwest of the São Paulo State. Through the Anvisa’s Notivisa system, it was computed the notifications characterized as ADRs and technical complaints from June 2012 to July 2014. The notifications that were not finalized, with status pending completion or with incomplete data, were excluded. The cases of ADRs were classified according to the criterion of severity, organ system affected and characterization of the suspected drug class. The characteristics of the sex and age of the patients involved were also investigated. Data were described as single frequency and proportions. Results: A total of 151 (84.8%) notifications of possible ADRs and 27 (15.2%) of technical complaints was recorded. Women (62.9%) aged 26-59 years (42.4%) were predominant among patients reported with ADRs. The majority of the reactions were skin disorders (33.1%), of moderate severity (70.2%), coming from drugs that act on the nervous system (35.8%). Regarding the technical complaints, the extravasation of liquid from the packaging material was the most described occurrence (40.7%). Conclusion: The reports associated with drugs are recurrent in the hospital setting and the characteristics reported base knowledge on the clinical profile of the adverse events presented.

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How to Cite
Oliveira, A. M. de, Rodrigues, V. A. V., Passerini, J. P., Pedreiro, P. B. Z., & Minto, B. A. (2018). Technical complaints and adverse drug reactions reported in a regional hospital in Brazil: a cross-sectional study. ABCS Health Sciences, 43(1). https://doi.org/10.7322/abcshs.v43i1.1015
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Original Articles

References

Zed PJ, Haughn C, Black KJL, Fitzpatrick EA, Ackroyd-Stolarz S, Murphy NG, et al. Medication-related emergency department visits and hospital admissions in pediatric patients: a qualitative systematic review. J Pediatr. 2013;163(2):477-83.https://dx.doi.org/10.1016/j.jpeds.2013.01.042

Freitas GRM, Tramontina MY, Balbinotto G, Hughes DA, Heineck I. Economic impact of emergency visits due to drug-related morbidity on a Brazilian hospital. Value Health Reg Issues. 2017;14(Suppl C):1-8.https://dx.doi.org/10.1016/j.vhri.2017.03.003

Laporte J-R. Fifty years of pharmacovigilance: medicines safety and public health. Pharmacoepidemiol Drug Saf. 2016;25(6):725-32. https://dx.doi.org/10.1002/pds.3967

Santoro A, Genov G, Spooner A, Raine J, Arlett P. Promoting and protecting Public Health: How the European Union Pharmacovigilance System Works. Drug Saf. 2017;40(10):855-69. https://dx.doi.org/10.1007/s40264-017-0572-8

Rydberg DM, Holm L, Engqvist I, Fryckstedt J, Lindh JD, Stiller CO, et al. Adverse drug reactions in a tertiary care emergency medicine ward - prevalence, preventability and reporting. PLoS One. 2016;11(9):e0162948. https://dx.doi.org/10.1371/journal.pone.0162948

Alatawi YM, Hansen RA. Empirical estimation of under-reporting in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). Expert Opin Drug Saf. 2017;16(7):761-7.http://dx.doi.org/10.1080/14740338.2017.1323867

Patel NS, Patel TK, Patel PB, Naik VN, Tripathi C. Hospitalizations due to preventable adverse reactions-a systematic review. Eur J Clin Pharmacol. 2017;73(4):385-98. https://dx.doi.org/10.1007/s00228-016-2170-6

Lobo MGAA, Pinheiro SMB, Castro JGD, Momenté VG, Pranchevicius MCS. Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil. BMC Pharmacol Toxicol. 2013;14:5. https://dx.doi.org/10.1186/2050-6511-14-5

Agência Nacional de Vigilância Sanitária (ANVISA). Sistema de Notificações para a Vigilância Sanitária (Notivisa). Disponível em: http://portal.anvisa.gov.br/notivisa Acesso em: 03 jan. 2017.

World Health Organization (WHO). The importance of pharmacovigilance: safety monitoring of medicinal products. Geneva: World Health Organization; 2002.

World Health Organization (WHO). International drug monitoring: the role of the hospital. Geneva: World Health Organization; 1966.

Agência Nacional de Vigilância Sanitária (ANVISA). Sistema Nacional de Notificações para a Vigilância Sanitária. Manual do Usuário: formulário para notificação de eventos adversos à medicamento. Disponível em: http://www.anvisa.gov.br/hotsite/notivisa/manual/ea_medicamento_profissional.pdf. Acesso em: 04 ago. 2017.

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49(9):2229-32.

National Institutes of Health. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE). US Department of Health and Human Services. 2009;4(3):1-78.

World Health Organization (WHO). Collaborating Centre for Drug Statistics Methodology, Guidelines for ATC classification and DDD assignment 2013. Oslo, 2012. Disponível em: https://www.whocc.no/filearchive/publications/1_2013guidelines.pdf/ Acesso em: 21 set. 2017.

Truven Health Analytics. Micromedex® Solutions. Disponível em: http://www.micromedexsolutions.com/home/dispatch. Acesso em: 21 set. 2017.

Mendes D, Alves C, Marques FB. Iatrogenia grave desconhecida, notificações e notificadores: resultados da actividade da Unidade de Farmacovigilância do Centro. Rev Port Med Geral Fam. 2012;28(1):34-40.

Chen CJ, Cheng CF, Lin HY, Hung SP, Chen WC, Lin MS. A comprehensive 4-year survey of adverse drug reactions using a network-based hospital system. J Clin Pharm Ther. 2012;37(6):647-51.https://dx.doi.org/10.1111/j.1365-2710.2012.01359.x

Ruiter R, Visser LE, Rodenburg EM, Trifiró G, Ziere G, Stricker BH. Adverse drug reaction-related hospitalizations in persons aged 55 years and over: a population-based study in the Netherlands. Drugs Aging. 2012;29(3):225-32. https://dx.doi.org/10.2165/11599430-000000000-00000

Pedrós C, Quintana B, Rebolledo M, Porta N, Vallano A, Arnau JM. Prevalence, risk factors and main features of adverse drug reactions leading to hospital admission. Eur J Clin Pharmacol. 2014;70(3):361-7.https://dx.doi.org/10.1007/s00228-013-1630-5

Kim B, Kim SZ, Lee J, Jung AH, Jung SH, Hahn HJ, et al. Clinical profiles of adverse drug reactions spontaneously reported at a single Korean hospital dedicated to children with complex chronic conditions. PLoS One. 2017;12(2): e0172425. https://dx.doi.org/ 10.1371/journal.pone.0172425

Rosli R, Ming LC, Abd Aziz N, Manan MM. A retrospective analysis of spontaneous adverse drug reactions reports relating to paediatric patients. PLoS One. 2016;11(6):e0155385. https://dx.doi.org/10.1371/journal.pone.0155385

Lima PFd, Cavassini ACM, Silva FAT, Kron MR, Gonçalves SF, Spadotto A, et al. Queixas técnicas e eventos adversos a medicamentos notificados em um hospital sentinela do interior de São Paulo, 2009-2010. Epidemiol Serv Saúde. 2013;22(4):679-86.http://dx.doi.org/10.5123/S1679-49742013000400014