medigraphic.com
ISSN 1560-4381 (Print)

2022, Number 2

<< Back Next >>

Correo Científico Médico 2022; 26 (2)

Characterization of the notifications of suspected adverse reactions at Urbano Noris municipality from Holguín

Leandro MM, Aguilar IOD, Morales GM

Language: Spanish
References: 26
Page: 26
PDF size: 270.36 Kb.


ABSTRACT

Introduction: Adverse drug reactions are a frequent cause of illness, disability or death. The quality of the reports is decisive for the effectiveness of pharmacovigilance.
Objective: To characterize the reports of suspected adverse drug reactions at Urbano Noris municipality.
Methods: A descriptive and cross-sectional study was carried out. The notifications were characterized taking into account the quality of the data, according to the Cuban pharmacovigilance system, sex, age, notifiers, level of care, pharmacological groups and the most reported reactions. In addition, the quality of the assessment of causality, severity and frequency of occurrence was analyzed. According to the criteria of the investigators, when notifications were correctly evaluated in accordance with the last three variables, they were classified as grade three.
Results: The notifications of grade two represented 79.6%, according to the quality of the data. Female patients with adverse drug reactions were 52.6% and adults were 48.4%. Pharmacists and doctors respectively made 60% and 26.53% of the reports. Diarrhea (10.4%), skin rashes (10%), nausea (7.6%) and hypotension (5.1%) as well as antimicrobials were the most reported. Out of the notifications, 71.6% were evaluated correctly, according to causality, severity and frequency of appearance.
Conclusions: Grade two notifications predominated, according to data quality, as well as adult patients and the female sex. Pharmacists and doctors made most of the notifications. Diarrhea, skin rashes and antimicrobials were the most reported. Grade three notifications prevailed, according to the quality of the evaluation.


REFERENCES

  1. Tarragó Portelles SS, Gravier Hernández R,del Valle Lizette G.La Farmacovigilancia en Cuba y la Infranotificaciones de Reacciones Adversas a los Medicamentos. Horiz Sanitario. 2019[citado 25/01/2021];18(1):7-15. Disponible en:http://www.scielo.org.mx/scielo.php?pid=S2007-74592019000100007&script=sci_arttext

  2. Rodríguez Duque R, Gómez Leyva B, Rodríguez Moldón Y, Díaz Armas MT. Las reacciones adversas como causa de hospitalización. CCM. 2019 [citado 25/01/2021];23(1):223-243. Disponible en: http://scielo.sld.cu/pdf/ccm/v23n1/1560-4381-ccm-23-01-223.pdf

  3. OMS. Seguridad del paciente. Ginebra,Suiza :OMS; 13/09/2019[citado 25/01/2021]. Disponible en: https://www.who.int/es/news-room/fact-sheets/detail/patient-safety

  4. Salas Rojas SG, Pérez Morales ME, Meléndez López SG, Castro Pastrana LI. Reacciones adversas a medicamentos relacionadas con ingresos y estancias hospitalarias: revisión sistemática de 2000-2011. Rev Mexicana Cien Farma. 2012 [citado 25/01/2021];43(3):19-35. Disponible en: http://www.redalyc.org/articulo.oa?id=57928310003

  5. 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 [citado 25/01/2021];70(3):361-367. Disponible en:https://doi.org/10.1007/s00228-013-1630-5

  6. Meier F, Maas R, Sonst A, Patapovas A, Müller F, Plank‐Kiegele B, et al. Adverse drug events in patients admitted to an emergency department: an analysis of direct costs. Pharmacoepidemiol Drug Saf. 2015 [citado 25/01/2021];24(2):176-186. Disponible en:https://onlinelibrary.wiley.com/doi/10.1002/pds.3663

  7. Oscanoa TJ, Lizaraso F, Carvajal A. Hospital admissions due to adverse drug reactions in the elderly. A meta-analysis. EurJ Clin Pharmacol. 2017 [citado 25/01/2021];73(6):759-70. Disponible en : https://doi.org/10.1007/s00228-017-2225-3

  8. Jiménez López G, Alfonso Orta I. Normas y procedimientos de trabajo del Sistema Cubano de Farmacovigilancia. La habana: MINSAP; 2015.

  9. Zavaleta Busto M, Rosete Reyes A. Reacciones adversas a medicamentos (RAM) en el Hospital Médica Sur. Avances y dirección de nuestros logros. Rev Méd Sur. 2007 [citado 25/01/2021];14(4):169-175. Disponible en: http://www.medigraphic.com/pdfs/medsur/ms-2007/ms074b.pdf

  10. 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 Mexicana Cien Farmac. 2017 [citado 25/01/2021];48(4):71-77. Disponible en:http://www.redalyc.org/articulo.oa?id=57956617008

  11. Ribeiro A, Lima S, Zampieri ME, Peinado M, Figueras A. Filling quality of the reports of adverse drug reactions received at the Pharmacovigilance Centre of São Paulo (Brazil): missing information hinders the analysis of suspected associations. Expert Opin Drug Saf.2017[citado 25/01/2021];16(12):1329-1334. Disponible en:https://www.tandfonline.com/doi/citedby/10.1080/14740338.2017.1369525?scroll=top&needAccess=true

  12. Jiménez López G, García Fariñas A, Gálvez González AM, Alfonso Orta I, Lara Bastanzuri MC, Calvo Barbado DM. Medicamentos notificados como productores de reacciones adversas graves en Cuba en un período de diez años. Rev Cubana Salud Pública.2014 [citado 01/01/2021];40(4): 263-275. Disponible en:http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0864-34662014000400003&lng=es

  13. Alfonso Orta I, Toledo Romaní ME, Coutín Marie G, Garcia Fariñas A, González Cruz R, Jiménez López G. Reacciones adversas a los antimicrobianos en Cuba (2003-2012). Rev Cubana Salud Pública. 2016 [citado 01/01/2021];42(2):294-305.Disponible enhttps://www.scielosp.org/article/ssm/content/raw/?resource_ssm_path=/media/assets/rcsp/v42n2/spu12216.pdf

  14. Casas Gross SM, Gross Fernández MC, Ramos Hernández L, Herrero Aguirre H, Malo de Molina RR. Reacciones adversas a medicamentos en el Hospital Provincial Docente Clinicoquirúrgico “Saturnino Lora Torres”. Medisan. 2016 [citado 01/01/2021];20(8):1032-1036. Disponible en: http://medisan.sld.cu/index.php/san/article/view/793

  15. Santos Muñoz L, Jiménez López G, Alfonso Orta I. Caracterización de las reacciones adversas medicamentosas de baja frecuencia de aparición. Rev Cubana Salud Pública. 2018 [citado 01/01/2021];44(1):71-85. Disponible en:https://www.scielosp.org/article/rcsp/2018.v44n1/71-85/es/

  16. Mattison DR. Pharmacokinetics in real life: sex and gender differences. J Popul Ther Clin Pharmacol. 2013 [citado 01/01/2021];20(3). Disponible en:https://jptcp.com/index.php/jptcp/article/view/364

  17. Eguale T, Buckeridge DL, Verma A, Winslade NE, Benedetti A, Hanley JA, et al. AAssociation of Off-label Drug Use and Adverse Drug Events in an Adult Population.JAMA Intern Med. 2016 [citado 01/01/2021];176(1):55-63. Disponible en:https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2467782

  18. Vignolo J, Vacarezza M, Álvarez C, Sosa A. Niveles de atención, de prevención y atención primaria de la salud. Arch Med Int. 2011[citado 01/02/2021];33(1):7-11. Disponible en: http://www.scielo.edu.uy/scielo.php?script=sci_arttext&pid=S1688-423X2011000100003

  19. Flórez J, Armijo J, Mediavilla A. Farmacología Humana.6a ed. Madrid, España:Masson; 2014.

  20. Mejía Acosta N, Alvarez Risco A, Solís Tarazona Z, Matos Valerio E, Zegarra Arellano E, Del Aguila Arcentales S. Reacciones Adversas a Medicamentos reportadas como resultado de la implementación de Atención Farmacéutica en la Farmacia Institucional DIGEMID-Ministerio de Salud de Perú. Pharmaceutical Care España. 2016 [citado 01/01/2021];18(2):67-74. Disponible en: https://pharmcareesp.com/index.php/PharmaCARE/article/view/311

  21. Bandekar MS, Anwikar SR, Kshirsagar NA. Quality check of spontaneous adverse drug reaction reporting forms of different countries. Pharmacoepidemiol Drug Saf. 2010[citado 01/01/2021];19(11):1181-1185. Disponible en:https://onlinelibrary.wiley.com/doi/10.1002/pds.2004

  22. Navarro Escayola E,Canós Villena JC. Protocolo de actuación en muerte súbita por anafilaxia. Rev Española Med Leg. 2011 [citado 01/01/2021];37(1):37-45. Disponible en:https://www.sciencedirect.com/science/article/abs/pii/S0377473211700608?via%3Dihub

  23. Ramasamy SN, Korb-Wells CS, Kannangara DR, Smith MW, Nan Wang,Roberts DM,et al.. Allopurionol hypersensitivity: a systematic review of all published cases 1950-2012. Drug Safaty. 2013 [citado 01/01/2021];36:953-980. Disponible en: https://doi.org/10.1007/s40264-013-0084-0

  24. Plessis L, Gómez A, García N, Cereza G, Figueras A. Lack of essential information in spontaneous reports of adverse drug reactions in Catalonia-a restraint to the potentiality for signal detection. Eur J Clin Pharmacol.2017 [citado 01/01/2021];73(6):751-758. Disponible en: https://doi.org/10.1007/s00228-017-2223-5

  25. Kelly WN. The quality of published adverse drug event reports. Ann Pharmacother.2003 [citado 01/01/2021];37(12):1774-1778.Disponible en:https://journals.sagepub.com/doi/10.1345/aph.1D202

  26. Kane Gill SL, Smithburger PL, Williams EA, Felton MA, Wang N , Seybert AL. Published cases of adverse drug reactions: has the quality of reporting improved over time?. Ther Adv Drug Saf. 2015[citado 01/01/2021];6(2):38-44. Disponible en:https://journals.sagepub.com/doi/10.1177/2042098615569725




2020     |     www.medigraphic.com