Descriptive study of adverse drug reactions in a tertiary care pediatric hospital in México from 2014 to 2017
In Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not been described in hospitalized children. To estimate the frequency of ADRs and describe them, as well as suspect drugs, in a tertiary care pediatric hospital...
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Published in | PloS one Vol. 15; no. 3; p. e0230576 |
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2020
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Abstract | In Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not been described in hospitalized children.
To estimate the frequency of ADRs and describe them, as well as suspect drugs, in a tertiary care pediatric hospital in Mexico.
A total of 1,649 Hospital Infantil de Mexico Federico Gómez ADR reports were analyzed. Completeness of the information was assessed, and ADRs severity and seriousness were assigned based on NOM-220-SSA1-2012, with causality being established according to the Naranjo algorithm. ADRs were classified with WHO Adverse Drug Reaction Terminology (WHO-ART). The drugs involved in ADRs were categorized according to the Anatomical Therapeutic Chemical (ATC) classification. Descriptive analysis was performed using the SPSS 20 statistical package.
Of all the reports, 5.8% lacked sufficient information for the analysis (grade 0). ADRs frequency ranged from 2.12% to 8.07%. ADRs occurred most commonly in children (56.9%), in the female gender (52%), in subjects with normal BMI Z-score (46.6%) and malnutrition (35.3%), diagnosed with neoplasms (72.2%) and in the Emergency Department (70.0%). ADRs were severe in 14.4% of cases, in 81.0% they were serious and 2.1% were classified as definite. Most common serious ADR was febrile neutropenia (44.5%). The 0.7% of patients recovering with sequelae; 1.1% died (with the medication being associated) and 70.3% were admitted to the hospital as a result of an ADR. Antineoplastic and immunomodulating agents were more commonly associated with serious ADRs.
ADRs affected morbidity and mortality, which is why strengthening pharmacovigilance programs in Mexican pediatric hospitals is necessary. |
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AbstractList | In Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not been described in hospitalized children.
To estimate the frequency of ADRs and describe them, as well as suspect drugs, in a tertiary care pediatric hospital in Mexico.
A total of 1,649 Hospital Infantil de Mexico Federico Gómez ADR reports were analyzed. Completeness of the information was assessed, and ADRs severity and seriousness were assigned based on NOM-220-SSA1-2012, with causality being established according to the Naranjo algorithm. ADRs were classified with WHO Adverse Drug Reaction Terminology (WHO-ART). The drugs involved in ADRs were categorized according to the Anatomical Therapeutic Chemical (ATC) classification. Descriptive analysis was performed using the SPSS 20 statistical package.
Of all the reports, 5.8% lacked sufficient information for the analysis (grade 0). ADRs frequency ranged from 2.12% to 8.07%. ADRs occurred most commonly in children (56.9%), in the female gender (52%), in subjects with normal BMI Z-score (46.6%) and malnutrition (35.3%), diagnosed with neoplasms (72.2%) and in the Emergency Department (70.0%). ADRs were severe in 14.4% of cases, in 81.0% they were serious and 2.1% were classified as definite. Most common serious ADR was febrile neutropenia (44.5%). The 0.7% of patients recovering with sequelae; 1.1% died (with the medication being associated) and 70.3% were admitted to the hospital as a result of an ADR. Antineoplastic and immunomodulating agents were more commonly associated with serious ADRs.
ADRs affected morbidity and mortality, which is why strengthening pharmacovigilance programs in Mexican pediatric hospitals is necessary. Introduction In Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not been described in hospitalized children. Objective To estimate the frequency of ADRs and describe them, as well as suspect drugs, in a tertiary care pediatric hospital in Mexico. Methods A total of 1,649 Hospital Infantil de Mexico Federico Gómez ADR reports were analyzed. Completeness of the information was assessed, and ADRs severity and seriousness were assigned based on NOM-220-SSA1-2012, with causality being established according to the Naranjo algorithm. ADRs were classified with WHO Adverse Drug Reaction Terminology (WHO-ART). The drugs involved in ADRs were categorized according to the Anatomical Therapeutic Chemical (ATC) classification. Descriptive analysis was performed using the SPSS 20 statistical package. Results Of all the reports, 5.8% lacked sufficient information for the analysis (grade 0). ADRs frequency ranged from 2.12% to 8.07%. ADRs occurred most commonly in children (56.9%), in the female gender (52%), in subjects with normal BMI Z-score (46.6%) and malnutrition (35.3%), diagnosed with neoplasms (72.2%) and in the Emergency Department (70.0%). ADRs were severe in 14.4% of cases, in 81.0% they were serious and 2.1% were classified as definite. Most common serious ADR was febrile neutropenia (44.5%). The 0.7% of patients recovering with sequelae; 1.1% died (with the medication being associated) and 70.3% were admitted to the hospital as a result of an ADR. Antineoplastic and immunomodulating agents were more commonly associated with serious ADRs. Conclusion ADRs affected morbidity and mortality, which is why strengthening pharmacovigilance programs in Mexican pediatric hospitals is necessary. In Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not been described in hospitalized children.INTRODUCTIONIn Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not been described in hospitalized children.To estimate the frequency of ADRs and describe them, as well as suspect drugs, in a tertiary care pediatric hospital in Mexico.OBJECTIVETo estimate the frequency of ADRs and describe them, as well as suspect drugs, in a tertiary care pediatric hospital in Mexico.A total of 1,649 Hospital Infantil de Mexico Federico Gómez ADR reports were analyzed. Completeness of the information was assessed, and ADRs severity and seriousness were assigned based on NOM-220-SSA1-2012, with causality being established according to the Naranjo algorithm. ADRs were classified with WHO Adverse Drug Reaction Terminology (WHO-ART). The drugs involved in ADRs were categorized according to the Anatomical Therapeutic Chemical (ATC) classification. Descriptive analysis was performed using the SPSS 20 statistical package.METHODSA total of 1,649 Hospital Infantil de Mexico Federico Gómez ADR reports were analyzed. Completeness of the information was assessed, and ADRs severity and seriousness were assigned based on NOM-220-SSA1-2012, with causality being established according to the Naranjo algorithm. ADRs were classified with WHO Adverse Drug Reaction Terminology (WHO-ART). The drugs involved in ADRs were categorized according to the Anatomical Therapeutic Chemical (ATC) classification. Descriptive analysis was performed using the SPSS 20 statistical package.Of all the reports, 5.8% lacked sufficient information for the analysis (grade 0). ADRs frequency ranged from 2.12% to 8.07%. ADRs occurred most commonly in children (56.9%), in the female gender (52%), in subjects with normal BMI Z-score (46.6%) and malnutrition (35.3%), diagnosed with neoplasms (72.2%) and in the Emergency Department (70.0%). ADRs were severe in 14.4% of cases, in 81.0% they were serious and 2.1% were classified as definite. Most common serious ADR was febrile neutropenia (44.5%). The 0.7% of patients recovering with sequelae; 1.1% died (with the medication being associated) and 70.3% were admitted to the hospital as a result of an ADR. Antineoplastic and immunomodulating agents were more commonly associated with serious ADRs.RESULTSOf all the reports, 5.8% lacked sufficient information for the analysis (grade 0). ADRs frequency ranged from 2.12% to 8.07%. ADRs occurred most commonly in children (56.9%), in the female gender (52%), in subjects with normal BMI Z-score (46.6%) and malnutrition (35.3%), diagnosed with neoplasms (72.2%) and in the Emergency Department (70.0%). ADRs were severe in 14.4% of cases, in 81.0% they were serious and 2.1% were classified as definite. Most common serious ADR was febrile neutropenia (44.5%). The 0.7% of patients recovering with sequelae; 1.1% died (with the medication being associated) and 70.3% were admitted to the hospital as a result of an ADR. Antineoplastic and immunomodulating agents were more commonly associated with serious ADRs.ADRs affected morbidity and mortality, which is why strengthening pharmacovigilance programs in Mexican pediatric hospitals is necessary.CONCLUSIONADRs affected morbidity and mortality, which is why strengthening pharmacovigilance programs in Mexican pediatric hospitals is necessary. Introduction In Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not been described in hospitalized children. Objective To estimate the frequency of ADRs and describe them, as well as suspect drugs, in a tertiary care pediatric hospital in Mexico. Methods A total of 1,649 Hospital Infantil de Mexico Federico Gómez ADR reports were analyzed. Completeness of the information was assessed, and ADRs severity and seriousness were assigned based on NOM-220-SSA1-2012, with causality being established according to the Naranjo algorithm. ADRs were classified with WHO Adverse Drug Reaction Terminology (WHO-ART). The drugs involved in ADRs were categorized according to the Anatomical Therapeutic Chemical (ATC) classification. Descriptive analysis was performed using the SPSS 20 statistical package. Results Of all the reports, 5.8% lacked sufficient information for the analysis (grade 0). ADRs frequency ranged from 2.12% to 8.07%. ADRs occurred most commonly in children (56.9%), in the female gender (52%), in subjects with normal BMI Z-score (46.6%) and malnutrition (35.3%), diagnosed with neoplasms (72.2%) and in the Emergency Department (70.0%). ADRs were severe in 14.4% of cases, in 81.0% they were serious and 2.1% were classified as definite. Most common serious ADR was febrile neutropenia (44.5%). The 0.7% of patients recovering with sequelae; 1.1% died (with the medication being associated) and 70.3% were admitted to the hospital as a result of an ADR. Antineoplastic and immunomodulating agents were more commonly associated with serious ADRs. Conclusion ADRs affected morbidity and mortality, which is why strengthening pharmacovigilance programs in Mexican pediatric hospitals is necessary. |
Author | Jiménez-Juárez, Rodolfo Norberto Olivar-López, Víctor Jasso-Gutiérrez, Luis Cicero-Oneto, Carlo Villanueva-García, Dina Hernández-Hernández, Maribelle Morales-Ríos, Olga García-Ruiz, Carlos |
AuthorAffiliation | 4 Intensive Therapy Department, Hospital Infantil de México Federico Gómez, Ciudad de México, México National Chiao Tung University College of Biological Science and Technology, TAIWAN 7 Department of Pediatrics, Centro Médico Nacional La Raza, Infectious Diseases Hospital, Instituto Mexicano del Seguro Social, Ciudad de México, México 3 Neonatology Department, Hospital Infantil de México Federico Gómez, Ciudad de México, México 6 Infectious Diseases Department, Hospital Infantil de México Federico Gómez, Ciudad de México, México 5 Emergency Department, Hospital Infantil de México Federico Gómez, Ciudad de México, México 1 Clinical Research Department, Hospital Infantil de México Federico Gómez, Ciudad de México, México 2 Hematological Oncology Department, Hospital Infantil de México Federico Gómez, Ciudad de México, México |
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Snippet | In Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not been described... Introduction In Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not... INTRODUCTION:In Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not... Introduction In Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not... |
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SubjectTerms | Acute Kidney Injury - etiology Adolescent Adult Adverse Drug Reaction Reporting Systems Algorithms Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use Biology and Life Sciences Body mass index Causality Child Child, Preschool Children Complications Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - mortality Drug-Related Side Effects and Adverse Reactions - pathology Drugs Emergency medical care Emergency medical services Female Gender Hospitals Hospitals, Pediatric Humans Infant Infant, Newborn Infectious diseases Male Malnutrition Medical diagnosis Medicine and Health Sciences Mexico - epidemiology Morbidity Mortality Neoplasms Neoplasms - diagnosis Neoplasms - drug therapy Neutropenia Patients Pediatrics Pharmaceutical industry Pharmacovigilance Sepsis Severity of Illness Index Sex Factors Side effects Tertiary Healthcare Young Adult |
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Title | Descriptive study of adverse drug reactions in a tertiary care pediatric hospital in México from 2014 to 2017 |
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