Outpatient Department – A Prospective Study at a Tertiary Care Teaching Hospital

Abstract

Objective: To assess prevalence and pattern of off-label and unlicensed use of drugs in paediatric outpatient department. Methods: In this prospective study, children attending paediatric outpatient department of a tertiary care teaching hospital were enrolled. Demographic data, clinical history and completeprescription given to the patient were noted. Prescriptions were analysed for off-label and unlicensed drug use with the help ofrecent British National Formulary for Children (BNFC) and National Formulary of India (NFI). Results: Total of 170 patient's data was collected over 2 months with mean age 4.19 ± 3.66 years. Out of total of 405 drugs prescribed, 41 (10.1%)-BNFC and 32 (7.9%)-NFI were used in off-label manner. Number of children who received at least one off-label drug as per BNFC and NFI was 22.4% and 17.1%, respectively. Most common off-label drug was amoxicillin being 48.8%-BNFC and 34.4%-NFI of all drugs prescribed in this manner. Most common category for off-label prescription was inappropriate dose. Only one case was noted for unlicensed drug use. Offlabel drug prescribing significantly correlated with age of the patient and number of drugs per prescription. Conclusion: Off-label drug use is prevalent in paediatric outpatient department, amoxicillin being the commonest drug.

The practice of off label prescribing and associated adverse drug reactions in pediatric inpatients in a tertiary care hospital in India

“…A study published by Bhadiyadara et al reported that out of 405 drugs, 10.1% drugs were used in an off label manner as per BNFC-2012. [9] Though their study was comparable to a previous outpatient study reported a decade back from UK which showed 10.5% offlabel prescription according to BNFC-1998, [10] our study identified a higher proportion of off-label drugs (27.9%) as per BNFC 2016-2017, which suggests the improvement in quality of the database due to periodic editions that reflect ever emerging clinical practices. Turner et al, studied drug use conditions in a PICU, published that 70% of the total patients received at least one off label drug and their percentages are similar to the findings of our study.…”

“…These two databases were selected as Micromedex is known for Micromedex is a well known source that provides easy access to a large amount of FDA approved data and the BNFC is a standard compendia used by physicians across the globe. The mean age of the population in our study was lesser than that seen in other studies based on Off‐label drug use in pediatrics in India . This could be attributed to the fact that a large proportion of the total patients enrolled in the current study were in the age group 1 month–2 years as compared to the number of patients enrolled in age groups 2–12 years due to the higher frequency of diseases such as upper and lower respiratory tract infections, seizure disorders and acute gastroenteritis occurring in this population.…”

“…The mean age of the population in our study was lesser than that seen in other studies based on Off-label drug use in pediatrics in India. [8,9] This could be attributed to the fact that a large proportion of the total patients enrolled in the current study were in the age group 1 month-2 years as compared to the number of patients enrolled in age groups 2-12 years due to the higher frequency of diseases such as upper and lower respiratory tract infections, seizure disorders and acute gastroenteritis occurring in this population. A study published by Bhadiyadara et al reported that out of 405 drugs, 10.1% drugs were used in an off label manner as per BNFC-2012.…”

“…[2] A stark similarity between our study and the other studies on is that salbutamol and ondansetron are often prescribed in an off label way. [2,9,13,15] Manufacturers of these drugs must take note of these studies so as to bring about a change in their labelling specifications. Three studies report paracetamol to be off label for age and dose whereas no prescription of paracetamol was considered as off label in our study as it was found to be prescribed according to labelled dose and age specifications.…”

“…Three studies report paracetamol to be off label for age and dose whereas no prescription of paracetamol was considered as off label in our study as it was found to be prescribed according to labelled dose and age specifications. [2,9,16] Though standardized pediatric textbooks and local guidelines indicate the use of many drugs in Used in children below 2 years Indicated for age group above 2 years. pediatrics as per a particular age, indication, dose and route for specific diseases, it has been found through our study that these uses are not reflected in the BNFC and Micromedex.…”