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2022, Number 1

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Rev Biomed 2022; 33 (1)

Incidence and characteristics of adverse drug reactions in a high specialty hospital, Merida. Yucatan, Mexico

Arcos-Díaz A, Soberanis-Monseral LA, Lara-Riegos JC, Arana-Argáez VE, Marín Alvarado CP, Ramírez-Camacho MA
Full text How to cite this article

Language: Spanish
References: 48
Page: 12-21
PDF size: 198.16 Kb.


Key words:

Pharmacovigilance, adverse drug reactions, hospital pharmacy, hospitalized patients.

ABSTRACT

Background. Adverse drug reactions (ADRs) are the cause of up to 12% of hospital admissions, in addition to aggravating the clinical condition of hospitalized patients, since they are more vulnerable to developing ADRs, given their pathophysiological conditions and the polypharmacy to which they are subjected. In this context, it is important to know the incidence and characteristics of ADRs, as an important element in the safety of hospitalized patients.
Objective. To determine the incidence and characteristics of ADRs reported to the Institutional Center for Pharmacovigilance of a high specialty hospital in the Yucatan Peninsula.
Material and methods. A retrospective study of the ADRs reported during 2017-2018. The incidence and characteristics of ADRs were analyzed regarding the type, imputability, and severity, affected systems and organs (SOC) and associated drugs.
Results. A total of 324 ADRs were analyzed, corresponding to 186 patients. The group aged 18-39 years old was the most affected. Obesity, diabetes, and hypertension were the diagnoses most associated with ADR and the most affected SOC were gastrointestinal, skin and subcutaneous tissue, and blood-lymphatic system. The drugs mainly associated with ADR were antibacterials, analgesics, and antineoplastics. 80.9% of the ADRs were type A, 53.7% were imputability grade possible and, 56.5% were of moderate severity.
Conclusions. Most of the ADRs were type A, of possible imputability and moderate severity, associated with the use of antibacterials, analgesics and antineoplastics, demonstrating the need to strengthen the hospital pharmacovigilance program and improve the safe use of drugs in hospitalized patients.


REFERENCES

  1. Baber N. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. Br J Clin Pharmacol. 1994 May; 37(5): 401-4. https://doi.org/10.1111/j.1365-2125.1994. tb05705.x.

  2. Pinzón JF, Maldonado C, Díaz JA, Segura O. Costos directos e impacto sobre la morbimortalidad hospitalaria de eventos adversos prevenibles a medicamentos en una institución de tercer nivel de Bogotá. Biomédica. 2011 Mar; 31(3): 307-15. https://doi.org/10.7705/biomedica. v31i3.320

  3. Vallano A, Agustí A, Pedrós C, Arnau de Bolós JM. Revisión sistemática de los estudios de evaluación del costo de las reacciones adversas a medicamentos. Gac Sanit. 2012 May; 26(3): 277-83. https://doi. org/10.1016/j.gaceta.2011.09.014

  4. Patel TK, Patel PB. Mortality among patients due to adverse drug reactions that lead to hospitalization: a meta-analysis. Eur J Clin Pharmacol. 2018 Jun; 74(6): 819-32. https://doi.org/10.1007/s00228-018-2441-5

  5. Hakkarainen KM, Hedna K, Petzold M, Hägg S. Percentage of patients with preventable adverse drug reactions and preventability of adverse drug reactions-a meta-analysis. PLoS One. 2012 Mar; 7(3): e33236. doi: 10.1371/journal.pone.0033236

  6. Alvarado-Ibarra M, Aguilar-Luévano J, López- Hernández MA. Polifarmacia en pacientes con enfermedades hematológicas, no geriátricos, durante atención intrahospitalaria. Med Int Mex. 2016 Mar; 32(2): 176-84. https://www.medigraphic.com/pdfs/ medintmex/mim-2016/mim162d.pdf

  7. Martínez-Arroyo JL, Gómez-García A, Sauceda- Martínez D. Prevalencia de la polifarmacia y la prescripción de medicamentos inapropiados en el adulto mayor hospitalizado por enfermedades cardiovasculares. Gac Med Mex. 2014 May; 150(1): 29-38. http://www. anmm.org.mx/bgmm/2014/S1/GMM_150_2014_ S1_029-038.pdf

  8. Bouvy JC, De Bruin ML, Koopmanschap MA. Epidemiology of adverse drug reactions in Europe: a review of recent observational studies. Drug Saf. 2015 May; 38(5): 437-53. https://doi.org/10.1007/s40264- 015-0281-0

  9. Salas S, Pérez M, Meléndez S, Castro L. Reacciones adversas a medicamentos relacionadas con ingresos y estancias hospitalarias: revisión sistemática de 2000- 2011. Rev Mex Cienc Farm. 2012 Jul; 43(3): 19-35. http://www.scielo.org.mx/scielo.php?script=sci_ arttext&pid=S1870-01952012000300003&lng=es.

  10. Castro LI. Farmacovigilancia: un concepto en constante evolución [Internet] Entorno UDLAP; 2017. [Citado 04 de marzo 2021] Disponible en: https://issuu.com/ webudlap/docs/farmacovigilancia

  11. Secretaria de Salud. NOM-220-SSA1-2016, instalación y operación de la Farmacovigilancia en México. Diario Oficial de la Federación 2017 Jul 19.

  12. Organización Mundial de la Salud. Clasificación Estadística Internacional de Enfermedades y Problemas Relacionados con la Salud, 10ª Revisión. Washington, D.C.; OPS; 2003.

  13. Medical Dictionary for Regulatory Activities. Versión 23.1. [Internet]. MedDRA, [actualizado 2020 septiembre; citado 2020 octubre]. Disponible en: https:// apps.meddra.org/selfservice/MSST_Default.aspx

  14. whocc.no [internet]. Norwegian: ATC/DDD Index 2020; [citado 2020 noviembre]. Disponible en: https://www. whocc.no/atc_ddd_index/

  15. Rawlins MD, Thompson JW. Mechanisms of adverse drug reactions; en: Textbook of adverse drug reactions. DM Davis (eds). Oxford University press. 4th Edición. New York, EUA, 1991, pp. 16-38.

  16. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981 Aug; 30(2): 239–45. doi:10.1038/clpt.1981.154

  17. Giardina, C, Cutroneo PM, Mocciaro, E, Russo GT, Mandraffino G, Basile G, et al. Adverse Drug Reactions in Hospitalized Patients: Results of the FORWARD (Facilitation of Reporting in Hospital Ward) Study. Front Pharmacol. 2018 Apr; 11(9): 350. doi: 10.3389/ fphar.2018.00350

  18. Zopf Y, Rabe C, Neubert A, Janson C, Brune K, Hahn EG, et al. Gender-based differences in drug prescription: relation to adverse drug reactions. Pharmacology. 2009 Oct; 84(6): 333-9. doi: 10.1159/000248311

  19. Davies EC, Green CF, Taylor S, Williamson PR, Mottram DR, Pirmohamed M. Adverse drug reactions in hospital in-patients: a prospective analysis of 3695 patient-episodes. PLoS One. 2009 Feb; 4(2):e4439. doi: 10.1371/journal.pone.0004439.

  20. Soldin OP, Chung SH, Mattison DR. Sex differences in drug disposition. J Biomed Biotechnol. 2011 Feb: 187103. doi: 10.1155/2011/187103.

  21. Dos Santos DB, Coelho HLL. Adverse drug reactions in hospitalized children in Fortaleza, Brazil. Pharmacoepidemiol Drug Saf. 2006 Sep; 15(9) : 635–40. https://doi.org/10.1002/pds.1187

  22. Giner MT. Alergia a medicamentos. Conceptos básicos y actitud a seguir por el pediatra. Pediatr Int. 2013; XVII(9): 637-51. https://www.pediatriaintegral.es/ wp-content/uploads/2013/xvii09/04/637-651%20 Alergia%20medicamentos.pdf

  23. Cruz-Pérez E, Castillo-Castillo M, Molina-Prior PE, Pascual-Mathey LI, Molina-Rodríguez G, Soto-Cid AH, et al. Caracterización de sospechas de reacciones adversas a medicamentos en un hospital de Xalapa, Veracruz. Rev Mex Cienc Farm. 2017 Jul; 48 (4): 71-7. https://www.redalyc.org/pdf/579/57956617008.pdf

  24. Villavicencio-Muñoz HD, Juárez-Cusirimay A, Pérez- Sierra H. Reacciones adversas a medicamentos en el Hospital Regional del Cusco. Rev Soc Peru Med Int. 2017 Sep; 30 (3), 134-39. https://doi.org/10.36393/spmi. v30i3.51

  25. Rodrigues MC, Oliveira C. Interacciones medicamentosas y reacciones adversas a los medicamentos en polifarmacia en adultos mayores: una revisión integradora. Rev. Latino-Am. Enfermagem. 2016 Apr; 24:e2800. [citado 2021 marzo]. Disponible en: https://www.scielo.br/j/ rlae/a/FtSs4nsL4HMBbX8yqgqkkSz/?lang=es. http:// dx.doi.org/10.1590/1518-8345.1316.2800.

  26. Krishna KCM, Regidi SR. A study of polypharmacy leading to adverse drug reactions in geriatric patients at tertiary care hospital. Indian J Pharm Pharmacol. 2018 Apr; 5(2): 97-100. https://doi.org/10.18231/2393- 9087.2018.0021

  27. Jayanthi CR, Renuka M, Panchaksharimath P. An observational Study to analyze the Adverse drug Reactions among the Elderly at A Tertiary Care Hospital. Biomed Pharmacol J. 2017 Feb; 10(1): 345-52. http:// dx.doi.org/10.13005/bpj/1115

  28. Salas S, Pérez M, Meléndez S. Farmacovigilancia intensiva en el servicio de medicina interna del Hospital Regional No.1 del Instituto Mexicano del Seguro Social en Tijuana, B.C. Rev Mex Cienc Farm. 2012 Nov; 43(4): 55-68. https://www.redalyc.org/pdf/579/57928311008. pdf

  29. Morales-Ríos O, Cicero-Oneto C, García-Ruiz C, Villanueva-García D, Hernández-Hernández M, Olivar- López V, et al. Descriptive study of adverse drug reactions in a tertiary care pediatric hospital in México from 2014 to 2017 PLoS One. 2020 Mar; 24;15(3):e0230576. doi: 10.1371/journal.pone.0230576

  30. Shamah-Levy T, Vielma-Orozco E, Heredia-Hernández O, Romero-Martínez M, Mojica-Cuevas J, Cuevas- Nasu L, et al. Encuesta Nacional de Salud y Nutrición 2018-19: Resultados Nacionales. Cuernavaca, México: Instituto Nacional de Salud Pública, 2020; 149-57. Disponible en: https://saludpublica.mx/index.php/spm/ article/view/11095

  31. Barbosa-Martín E, Fajardo-Niquete I, Sosa-Valadez F, Cetina-Sánchez F, Puc-Encalada I, Vargas-Espinosa R, et al. Estudio poblacional sobre el estado de salud y nutrición de habitantes de la ciudad de Mérida, México. Rev Esp Nut Hum Diet. 2016 Jun: 20(3); 208- 15. https://dx.doi.org/10.14306/renhyd.20.3.217

  32. Sharma H, Singh GN. Adverse events associated with antidiabetics: An analysis of VigiFlow data. Innov Pharm Pharmacother. 2013; 1(2): 91–4. Disponible en: http:// innpharmacotherapy.com/Abstract.aspx?ArticleID=22 [en línea] [fecha de acceso 13 de marzo de 2021].

  33. Sudhakar R, George M, Yasaswini B, Sundararajan N, Ahamada M. Adverse drug reactions associated with anti-hypertensive drugs and its management. IJPSR, 2016 Dec; 7(3): 898-905. http://dx.doi.org/10.13040/ IJPSR.0975-8232.7(3).898-05

  34. Telessy I, Buttar H. Obesity related alterations in pharmacokinetics and pharmacodynamics of drugs: emerging clinical implications in obese patients-part I. Adipobiology. 2017 Dec; 9: 29-38. Disponible en: https://journals.mu-varna.bg/index.php/adipo/article/ view/4989/4259. [en línea][fecha de acceso 13 marzo 2021]

  35. Haile DB, Ayen WY, Tiwari P. Prevalence and assessment of factors contributing to adverse drug reactions in wards of a tertiary care hospital, India. Ethiop J Health Sci. 2013 Mar; 23(1): 39-48. PMID: 23559837; PMCID: PMC3613814.

  36. Patel TK, Patel PB. Incidence of Adverse Drug Reactions in Indian Hospitals: A Systematic Review of Prospective Studies. Curr Drug Saf. 2016 Apr; 11(2): 128-36. https:// doi.org/10.2174/1574886310666150921104523

  37. Alonso-Carbonell L, García-Milián AJ, López-Puig P, Yera-Alós I, Blanco-Hernández N. Patrón de reacciones adversas a medicamentos referidas por la población mayor de 15 años. Rev Cubana Med Gen Integr. 2009 Mar. 25(1). [citado 2021 abril]. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid =S0864-21252009000100004

  38. Esteban O, Navarro C, González F, Lanuza FJ, Montesa C. Análisis de la incidencia y de las características clínicas de las reacciones adversas a medicamentos de uso humano en el medio hospitalario. Rev Esp Salud Publica. 2017 Dec; 22;91. [citado abril 2021], e201712050. Disponible en: http://scielo.isciii.es/scielo.php?script=sci_ arttext&pid=S1135-57272017000100424&lng=es&nrm =iso

  39. Yang F, Chen Z, Chen SA, Zhu Q, Wang L, Xiong H, et al. Clinical profile of cutaneous adverse drug reactions: a retrospective study of 1883 hospitalized patients from 2007 to 2016 in Shanghai, China. Eur J Dermatol. 2020 Feb; 30(1): 24-31. doi: 10.1684/ejd.2020.3713. PMID: 32031529.

  40. Thiesen S, Conroy EJ, Bellis JR, Bracken LE, Mannix HL, Bird KA, et al. Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children-a prospective observational cohort study of 6,601 admissions. BMC Med. 2013 Nov; 11: 237. doi: 10.1186/1741-7015-11-237. PMID: 24228998; PMCID: PMC4225679.

  41. Gandhi TK, Bartel SB, Shulman LN, Verrier D, Burdick E, Cleary A, et al. Medication safety in the ambulatory chemotherapy setting. Cancer. 2005 Dec; 104(11): 2477- 83. doi: 10.1002/cncr.21442. PMID: 16245353.

  42. Mota DM, Vigo Á, Kuchenbecker RS. Reações adversas a medicamentos no sistema de farmacovigilância do Brasil, 2008 a 2013: estudo descritivo. Cad Saude Publica. 2019 Aug; 35(8): e00148818. Portuguese. doi: 10.1590/0102-311X00148818. PMID: 31460613.

  43. Davies EC, Green CF, Taylor S, Williamson PR, Mottram DR, Pirmohamed M. Adverse drug reactions in hospital in-patients: a prospective analysis of 3695 patient-episodes. PLoS One. 2009 Feb; 4(2): e4439. doi: 10.1371/journal.pone.0004439. PMID: 19209224; PMCID: PMC2635959.

  44. Gallagher RM, Kirkham JJ, Mason JR, Bird KA, Williamson PR, Nunn AJ, et al. Development and interrater reliability of the Liverpool adverse drug reaction causality assessment tool. PLoS One. 2011 Dec; 6(12): e28096. doi: 10.1371/journal.pone.0028096. Epub 2011 Dec 14. PMID: 22194808; PMCID: PMC3237416.

  45. Varallo FR, Planeta CS, Herdeiro MT, Mastroianni PC. Imputation of adverse drug reactions: Causality assessment in hospitals. PLoS One. 2017 Feb; 12(2): e0171470. doi: 10.1371/journal.pone.0171470. PMID: 28166274; PMCID: PMC5293251.

  46. Behera SK, Das S, Xavier AS, Velupula S, Sandhiya S. Comparison of different methods for causality assessment of adverse drug reactions. Int J Clin Pharm. 2018 Aug; 40(4): 903-10. doi: 10.1007/s11096-018-0694-9. Epub 2018 Jul 26. PMID: 30051231.

  47. Théophile H, Arimone Y, Miremont-Salamé G, Moore N, Fourrier-Réglat A, Haramburu F, et al. Comparison of three methods (consensual expert judgement, algorithmic and probabilistic approaches) of causality assessment of adverse drug reactions: an assessment using reports made to a French pharmacovigilance centre. Drug Saf. 2010 Nov; 33(11): 1045-54. doi: 10.2165/11537780- 000000000-00000. PMID: 20925441.

  48. Valdez-Ramírez L, Serrano-Medina A, Cornejo-Bravo J. Adverse drug recations´ reporting in a Mexican hospital. Int. J. Pharm. Pract. 2020 May; 28: 660-62. doi: 10.1111/ ijpp.12639. Epub 2020 May 31. PMID: 32476179.




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Rev Biomed. 2022;33