BACKGROUND: Prescribing medicines in an unlicensed and off-label manner for children is a widespread practice around the world.
OBJECTIVES: To determine the extent and predictors of off-label respiratory drug prescriptions for children in the outpatient clinics of a hospital in Malaysia.
SETTING: Outpatient clinics at the Universiti Kebangsaan Malaysia Medical Centre, a tertiary teaching hospital in Malaysia.
METHODS: The pharmacy-based computer system and medical records of the patients were utilized to collect data from 220 pediatric patients who were prescribed at least one respiratory drug from July 2011 to December 2011.
MAIN OUTCOME MEASURE: Characteristics of the off-label respiratory drug prescriptions were measured.
RESULTS: A total of 134 children (60.9 %) received at least one respiratory drug prescribed in an off-label manner. The most common reasons for the off-label prescribing of drugs were off-label use by indication (31.5 %), followed by higher than the recommended dose (24.9 %) and lower than the recommended frequency (17.1 %). Diphenhydramine was the most common respiratory drug prescribed off-label. The number of medications prescribed was the only significant predictor of off-label prescription of respiratory drugs. Pediatric patients receiving 4-6 medications were 7.8 times more likely to receive at least one off-label respiratory drug compared to pediatric patients that received 1-3 medications (OR 7.8, 95 % CI 1.74-37.44).
CONCLUSION: There was substantial prescribing of respiratory drugs for children in an off-label manner at the outpatient clinics at the Universiti Kebangsaan Malaysia Medical Centre. This highlights the need for more research to be carried out on respiratory drugs in the pediatric population.
Study site: Pusat Perubatan Universiti Kebangsaan Malaysia (PPUKM)
Background Antihistamines are widely prescribed to children but should be used with caution in young children. Objective To determine the paediatric prescribing pattern of antihistamines with a focus on the off-label prescribing and factors that influence such prescribing. Setting Paediatric wards of a tertiary care hospital setting in Malaysia. Methods The pharmacy-based computer system and medical records were used to collect the required data. Labelling status of each antihistamine was determined based on the information provided in the product leaflets. Main outcome measure Antihistamines prescribed off-label and factors associated with such prescribing. Results Of the 176 hospitalised children aged <18 years prescribed with an antihistamine in the year 2012, 60.8 % received it in an off-label manner. Of 292 antihistamine prescription items, 55.5 % were prescribed off-label. Loratadine (35.3 %) was the most frequently prescribed antihistamine and chlorpheniramine maleate (34.0 %) was the most common antihistamine prescribed off-label. The main reason for the off-label prescribing of antihistamines was prescribing at higher than the recommended dose (30.2 %). Binary logistic regression showed that children aged <2 years (OR 12.65; 95 % CI 2.87-55.67) and the number of medications received (OR 1.14; 95 % CI 1.00-1.29) were significant predictors for the off-label prescribing of antihistamines. Conclusion Prescribing antihistamines for children in an off-label manner was prevalent at the studied locations and warrants further investigation on the consequences of such prescribing.