BackgroundIt is interesting to note that limited studies have been done on the off-label drug use in the area of paediatric nephrology. Furthermore, information on the use of off-label drugs, especially in paediatric patients with nephrotic syndrome, is still lacking in Indonesia. Nephrotic syndrome is responsible for one of major chronic diseases in children and subsequently patients should take their medicines long term.PurposeTo estimate the prevalence of off-label and unlicensed prescribing in paediatric outpatients with nephrotic syndrome in a major teaching hospital in Indonesia.Material and methodsA retrospective study was conducted in hospital using medical records from paediatric outpatients with nephrotic syndrome during the period January to December 2015. Patient and prescribing data were collected, and drugs were classified as on-label or off-label/unlicensed based on Indonesia National Drug Information (IONI). Thereafter, off-label drugs were categorised with a hierarchical system of age, indication, route of administration and dosage.ResultsThere were 1864 drugs with 70 different types of drugs prescribed to 89 patients. The data revealed that 1390 (74.5%) of the drugs prescribed were off-label/unlicensed. The majority use of off-label drugs was mainly due to age (n=1200; 88.9%) while the remaining reasons were due to dosage (n=134; 9.9%) and indication (n=16: 1.2%). With regards to therapeutic category, non-diuretic antihypertensive agents (n=689; 51%) and immunosuppressants (n=455; 33.7%) were the top two most frequent drug categories used in an off-label manner. The most commonly used off-label drugs were prednisone (n=286), lisinopril (n=171) and losartan (n=169). Further, it was found that prednisone also accounted for the most frequent unlicensed drug. Off-label prescribing was common in paediatric outpatients with nephrotic syndrome where every patient received at least one off-label drug. It appears that off-label prescribing was not affected by patient age or gender.ConclusionDespite the high prevalent of off-label prescriptions in paediatric outpatients with nephrotic syndrome, this use conformed to evidence based prescribing. Measures should be conducted to support clinical trials in paediatrics and subsequently revise IONI as the standard drug information in Indonesia.References and/or acknowledgementsWe would like to acknowledge the Faculty of Pharmacy Pancasila University for granting research funding to support this study.No conflict of interest
Brown rice, derived from white rice with the removal of the husk, contains higher dietary fiber and a lower glycemic index than regular white rice. These advantages can be an alternative diet for individuals with type 2 diabetes mellitus. Type 2 diabetes mellitus is a metabolic disease ranked as the fourth leading cause of death in the world, often associated with obesity. In addition, insulin insensitivity in individuals with type 2 diabetes leads to increased hunger (polyphagia) and overeating, resulting in increasing BMI and waist circumference. The purpose of this study is to determine the effect of the brown rice diet intervention on BMI and waist circumference of patients with type 2 diabetes. This study was a pre-experimental study without control variables and the sample was not selected randomly, using a one-group pretest-posttest design with a 3-month intervention. Data analysis in this study used the Shapiro-Wilk normality test followed by the paired t-test to determine the difference between two paired samples. The statistical results showed significant changes in BMI and abdominal circumference (p = 0.002 and p = 0.008, respectively). In conclusion, there are differences in BMI and abdominal circumference of patients with type 2 diabetes mellitus before and after the intervention of a brown rice-based diet menu.
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