Parents’ awareness and perspective on off‑label medicines use in children

The lack of pediatric drug labeling is a long-standing problem for prescribers and drug regulatory bodies. As a result, medicines are prescribed in an off-label manner, which is inconsistent with its approved prescribing limits. The magnitude of off-label prescribing is accounted to be between 18% and 60% in pediatric wards. However, off-label prescribing may denote best evidence-based medicine, but, in several cases, benefit-risk is not well established. There are reports that suggest that off-label use is associated with adverse drug reactions and, hence, patient safety is jeopardized. Most clinicians recognize off-label prescribing as proper and believe that the benefits outweigh the risks and even their understanding of consequences appears to be negligible, with a low level of worry about the risk of side-effects, unevaluated efficacy and issues relating to informed consent. Parents are generally considered most suitable for conveying children therapy information, but are not specifically told about the off-label use of medicines in children. Hence, we aimed to evaluate their knowledge and attitude to off-label medicines. A cross-sectional study-based questionnaire (Appendix) was used comprising 18 questions on several aspects of off-label medicine use in children. The survey participants were selected randomly from various areas of Ahmedabad and Gandhinagar city of the state of Gujarat. We presumed that parents might not be aware of the drug development and approval procedure; hence, we presented a “slide-show” to explain invention of medicine, animal testing, clinical trials, licensing procedure, how and why drugs are used as “off-label” and benefit and risk of off-label medicine use. The research study followed ethical guidelines as per the Declaration of Helsinki. The responses of 407 parents representing various socioeconomic groups, children’s health status and education backgrounds were taken.