Identifying adverse drug events in patients at a pediatric ward in a Brazilian hospital: application and performance of the triggers

Caetano, Simone Cristina Rodrigues de Carvalho; Silva, Luiz Fernando Emidio da; Guaraldo, Lusiele; Giordani, Fabíola

doi:10.1590/1806-93042021000400007

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Revista Brasileira de Saúde Materno Infantil

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ORIGINAL ARTICLES • Rev. Bras. Saude Mater. Infant. 21 (4) • Oct-Dec 2021 • https://doi.org/10.1590/1806-93042021000400007 copy

Identifying adverse drug events in patients at a pediatric ward in a Brazilian hospital: application and performance of the triggers

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Objectives:

to evaluate the performance of a trigger tool in identifying adverse drug events (ADE) in hospitalized children.

Methods:

a retrospective cohort study review on 133 medical records at a federal maternal and child reference hospital in Rio de Janeiro in 2016. A list of 14 triggers was developed to detect ADE in the pediatric population. Three steps were performed: (1) search for triggers; (2) selection of suspected cases of ADE and (3) final determination of ADE by experts’ consensus.

Results:

360 triggers were identified in 100 hospitalizations (75.2%), with an average of 2.7 triggers/ hospitalization. The most frequent triggers were “abrupt medication stop” (79.7%); “antiemetics use” (8.9%) and “laxatives use” (7.2%); while the “diphenhydramine use”, “phytomenadione use” and “excessive sedation/lethargy/fall/hypotension” obtained the highest performance indicating ADE every time they occurred. Thirty-one ADE were identified in 12.8% of the hospitalizations; 11 (35.5%) ADE were detected without the aid of the triggers thus, pruritus and diarrhea were the most frequent.

Conclusion:

the trigger tool proved to be useful in identifying ADE in hospitalized children, especially if high performance and high frequency triggers are used in identifying the events. The inclusion of the triggers “diarrhea” and “pruritus”, may favor the identification of ADE in patients at pediatric wards.

Key words:
Drug-related side effects and adverse reactions; Drug monitoring; Pediatric Hospitals; Hospitalization; Pharmacoepidemiology; Patient’s safety

Triggers	Description and rationale	Observations
Medications
Diphenhydramine use	Antihistamine. May have been used to treat allergic reaction caused by the medication.	The triggers that refer to the use of a medication are identified in the prescriptions. The reasons for the use of the medication should be identified with a view to ruling out alternative causes and confirming the event
Phytomenadione use	Antihemorrhagic. May have been used to treat signs of bleeding caused by the medication.
Flumazenil use	Antidote for benzodiazepine. Check medical records for hypotension or prolonged sedation after benzodiazepine use.
Antiemetic use	Requires careful analysis to rule out alternative causes that prompted the use of antiemetics and to determine if there was actually an ADE.
Naloxone use	Opioid antidote. Check medical records for signs of opioid toxicity, such as respiratory depression, nausea and vomiting, constipation, and urinary retention.
Calcium polystyrenesulfonate use	Ion exchange resin used in the treatment of hyperkalemia. Correlate drug use with elevated serum potassium levels.
Laxatives use	Search for evidence of medication-induced constipation in prescriptions and in patient’s clinical evaluation records.
Clinical signs and symptoms
Excess sedation/ lethargy/ fall/ hypotension	Search for the relation between these events and the administration of sedative, analgesic, or muscle relaxer medications.	Search the clinical evaluation records performed by the assistance team
Skin rash	Check medical record for a correlation between the event and the administration of a medication.
Laboratorial Test Results
Partial Thromboplastin Time (PTT)	Verify the correlation between bleeding signs and the use of heparin.	PTT > 100 seconds
Increased serum creatinine	Check for administration of nephrotoxic medication and exclude alternative causes of renal failure, such as pre-existing kidney disease or diabetes.	Alteration > 0.4 mg/ dL
Hypoglycemia	Correlate hypoglycemia with medication use.	Blood glucose < 40 mg/ dL
Hyperkalemia	Check for correlation of hyperkalemia with medication use.	Values > 5.5 mg/ dL
Clinical conduct
Abrupt medication stop	Interruption of a medication may indicate the occurrence of ADE. It is necessary to exclude alternative causes for the interruption of the medication.	The identification of this trigger considered the use of the word "suspended" in the prescription.

Trigger/Performance	Triggers per 100 hospitalizations* (1)	ADE per 100 hospitalizations* (2)	Relative performance of the riggers (3) = (2)/₍₁₎ × 100
High performance
Diphenhydramine use	0.8	0.8	100.0
Phytomenadione use	3.0	3.0	100.0
Excess of sedation/ lethargy/ fall/ hypotension	1.5	1.5	100.0
Intermediate performance
Skin rash	2.3	1.5	66.7
Low performance
Laxatives use	19.5	2.3	11.5
Antiemetics use	24.1	0.8	3.1
Abrupt medication stop	215.8	5.3	2.4
Naloxone use	0.8	0.0	0.0
Hypoglycemia	0.8	0.0	0.0
Hyperkalemia	2.3	0.0	0.0

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[1] Authors’ contribution

Caetano SCRC participated in the conception, data collection, data analysis and interpretation, article writing and approval of the final version. Silva LFE participated in the data collection. Guaraldo L participated in the conception, article writing, and approval of the final version. Giordani F participated in the conception, data analysis and interpretation, article writing and approval of the final version.