Prescribing Patterns and Pharmacovigilance of Antihistamines in Children
Date Issued
2009
Date
2009
Author(s)
Lee, Wan-Hua
Abstract
Background lthough H1-antihistamines, one of the common drugs used in children, have been introduced to clinical use for more than 60 years, many of them were deficient of appropriate clinical trial evaluations. Additionally, based on ethic and practical factors, it’s difficult to promote a clinical trial to children, which makes it insufficient information to prove efficacy and safety of antihistamines and makes pediatric drug are prescribed ”off-label” excessively which may increase potential risk of adverse drug reactions in children. Therefore, it is worth to analyze current status of antihistamine usage in children. bjective e focus the study on analyzing the prescribing patterns of antihistamines by clinicians for children, and investigate the risk of adverse drug reactions including neurological-, psychological-, and cardiac-related events related to antihistamines. ethods he study used the National Health Insurance Research Database (NHIRD) in 2007 and extracted data of patients aged below 18, focusing on prescriptions containing antihistamines to analyze prescribing patterns in Taiwan. Antihistamine prescriptions were quantified as person-time to analyze the prescription pattens associated with different settings of hospital and prescribers. Bseides, we make use of a retrospective study to analyze antihistamine-related adverse events, including insomnia, movement disorders, psychosis, seizures, consciousness changes and arrhythmia. The analyses were done by using sampling data (one tenth of original data) from patients aged below 18 in 2007 with exclusion of data from those with underlying disorders of neurologic, psychotic, and cardiovascular system in 2006. We constructed time-dependent Cox’s proportional hazard models for each variable. esults mong a total of 205841 out-patients aged under 18 from the NHIRD in 2007, 86.6% of children received at least one antihistamine during visits and 61.1% prescriptions contained some antihistamines. Children aged between 2 to 12 (76.77%) were the major age group receiving antihistamines and 87.3% of antihistamine usages were 1st-generation antihistamines. The top 10 frequently used antihistamines were chlorpheniramine, cyproheptadine, dexchlorpheniramine, carbinoxamine, triprolidine, mequitazine, cetirizine, loratadine, buclizine and brompheniramine. Oral solid form (83.4%) was the major dose form of antihistamine, and multi form was 37.0%. Most antihistamines were used for acute respiractory infection, and a high percentage of 2nd-generation antihistamines were used in chronic respiractory disease and dermatitis. Pediatric and E.N.T. departments were the major medical utilizations of antihistamines. More than one antihistamine were used in 31.1% of prescriptions, especially for pediatricians (48.68%) and private clinics (66.13%). e sampled one tenth of original data to get 19000 patients whose ages was 10.7 ± 5.0 years in average for analysis of drug-associated adverse events. Patients exposed to 1st-generation antihistamines are more likely to experience insomnia than those who did not (HR = 3.72, 95% CI=1.21-11.44, p = 0.022), and 1st -generation antihistamines in multi liquid form were more likely to be associated with insomnia (HR = 4.17, 95% CI = 1.09-16.00, p = 0.0377). Patients exposed to 1st -generation antihistamines were more likely to have movement disorders than those who didn’t (HR = 9.56, 95% CI = 4.72-19.38, p < 0.0001). Patients used 1st -generation antihistamines were more likely to have consciousness changes than those who didn’t (HR = 1.45, 95% CI = 1.10-1.92, p = 0.0089). The occurrence of seizures and arrhythmia did not significantly related to any variables in the analysis. onclusions hildren aged between 2 to 12 were the major age group receiving antihistamines. Antihistamines were used in 6 out of every 10 prescriptions. Most antihsitamines were 1st -generation antihistamines, and the major dose forms were oral solid form. Chlorpheniramine, cyproheptadine, dexchlorpheniramine, carbinoxamine were most commonly used. More than one antihistamine were used in 31.1% of prescriptions. Insomnia, movement disorders, and consciousness changes were releated to the use of 1st -generation antihistamine, but not 2nd-generation antihistamines. Otherwise, using the multi liquid form of 1st -antihistamines has a higher hazard ratio to induce insomnia. Events of seizures and arrythmeia were not related to the use of antihistamines in our study. Further studies may use different strategies to delineate the drug safety of antihistamine use in children, including correlating different categories of antihistamine’s structures and adverse events, using questionnaires to obtain direct information from patients, and prolonging the duration of study to increase the sample size.
Subjects
antihistamine
children
prescription patterns
drug safety
National Health Insurance Research Database
Taiwan
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