Analysis of antiseizure drug‐related adverse reactions from the electronic health record using the common data model

Abstract

Objective: Antiseizure drugs (ASDs) are known to cause a wide range of adverse drug reactions (ADRs). Recently, electronic health care data using the common data model (CDM) have been introduced and commonly adopted in pharmacovigilance research. We aimed to analyze ASD-related ADRs using CDM and to assess the feasibility of CDM analysis in monitoring ADR in a single tertiary hospital. Methods: We selected five ASDs: oxcarbazepine (OXC), lamotrigine (LTG), levetiracetam (LEV), valproic acid (VPA), and topiramate (TPM). Patients diagnosed with epilepsy and exposed to monotherapy with one of the ASDs before age 18 years were included. We measured four ADR outcomes: (1) hematologic abnormality, (2) hyponatremia, (3) elevation of liver enzymes, and (4) subclinical hypothyroidism. We performed a subgroup analysis to exclude the effects of concomitant medications. Results: From the database, 1344 patients were included for the study. Of the 1344 patients, 436 were receiving OXC, 293 were receiving LTG, 275 were receiving LEV, 180 were receiving VPA, and 160 were receiving TPM. Thrombocytopenia developed in 14.1% of patients taking VPA. Hyponatremia occurred in 10.5% of patients taking OXC. Variable ranges of liver enzyme elevation were detected in 19.3% of patients taking VPA. Subclinical hypothyroidism occurred in approximately 21.5% to 28% of patients with ASD monotherapy, which did not significantly differ according to the type of ASD. In a subgroup analysis, we observed similar ADR tendencies, but with less thrombocytopenia in the TPM group. Significance: The incidence and trends of ADRs that were evaluated by CDM were similar to the previous literature. CDM can be a useful tool for analyzing ASDrelated ADRs in a multicenter study. The strengths and limitations of CDM should be carefully addressed. K E Y W O R D Sadverse drug reaction, antiseizure drugs, common data model, epilepsy, pharmacovigilance | 611 CHOI et al.

Enhancing Pediatric Adverse Drug Reaction Documentation in the Electronic Medical Record

“…Although the increased detection of ADRs after incorporation of a prospective pharmacovigilance program is well documented, these programs are unfortunately not the standard in all hospitals. Developing standardized EMR alerts or reports to detect ADRs requires time and infrastructure 3,6,16,20,21 . In addition, personnel, typically a clinical pharmacist, are needed to evaluate automated EMR reports and investigate potential ADRs 20,22 …”

“…Developing standardized EMR alerts or reports to detect ADRs requires time and infrastructure. 3,6,16,20,21 In addition, personnel, typically a clinical pharmacist, are needed to evaluate automated EMR reports and investigate potential ADRs. 20,22 Although personnel, EMR tools, and usability are very important, education and a positive culture of ADR reporting can be invaluable in increasing ADR reporting rates.…”

How closely is COVID-19 related to HCoV, SARS, and MERS? : Clinical comparison of coronavirus infections and identification of risk factors influencing the COVID-19 severity using common data model (CDM)

“…Our research has a great significance that we effectively utilized the big data from the integrated model, the CDM, within one of the biggest national hospitals in South Korea. CDM research has been expanded in its scope and conducted worldwide for the vitalization of medical research 19 . With the use of commonly formatted EMR records, our research successfully reflects the real-world challenges in the context of coronavirus.…”

Acute Levetiracetam-Induced Thrombocytopenia in an Anticoagulated Immunocompetent Patient

“…Levetiracetam (LEV) is a commonly used antiepileptic medication for the prophylaxis and treatment of focal and generalized seizures due to its efficacy, tolerance, good pharmacokinetic profile, and relatively benign adverse effects [1][2][3]. In an open-label placebo-controlled study by Abou-Khalil et al, adverse effects observed in 10% or more of users at individualized doses of 1,000-3,000 mg/day were asthenia, nausea, dizziness, somnolence, nervousness, anorexia, psychiatric side effects as well as other tolerable side effects [4].…”

“…Compared to other similarly used anti-seizure medications, severe adverse effects like hepatotoxicity, hemodynamic imbalances, pancytopenia, or significant drug interactions are not usually associated with its use [5][6]. However, thrombocytopenia has been reported with LEV use in several clinical settings and patient populations, oftentimes along with other thrombocytopenia-inducing medications [1,[7][8][9][10][11][12]. Here, we report a case of acute significant thrombocytopenia that developed following LEV use in the setting of status epilepticus in an anticoagulated immunocompetent patient.…”