title: Awareness about and views of parents on the off-label drug use in children.
abstract: BACKGROUND
  Off-label use of drugs is widely prevalent in children mainly due to a limited data generated in children during drug development process. Parents play a critical role in giving consent for their child to participate in clinical trials. Very few studies have assessed the opinion of the parents regarding such use and permitting their child to participate in clinical trials.
  
  
  OBJECTIVE
  In view of lack of information about the awareness among parents regarding both off-label drug use in children as well as about allowing their child to participate in clinical research especially from a developing country, this study was conducted.
  
  
  METHODS
  Adults accompanying patients in a tertiary care hospital were administered a validated, structured questionnaire following written informed consent. The questionnaire consisted of 18 items broadly divided into 5 themes - parental views on safety and labelled use of drugs in children, awareness of off-label drug use in children, communication from healthcare worker about it, parental views on off-label drug use in children and willingness to allow their child to participate in a clinical trial. Chi-square or Fisher's exact probability test and McNemar's test were used for analysis.
  
  
  RESULTS
  Initially, a majority of the participants felt that the drugs used in children in hospital (89.5%) and prescribed by a family physician (80.3%) were either safe or extremely safe while after the concept of off-label drug use is explained, a significant reduction in the proportion (59.3% in hospital and 59.8% by family physician) of parents felt the same. Only 30% parents were aware of off-label drug use in children. Ninety-three percent of the parents wanted to be informed whenever a doctor prescribes a drug in an off-label manner and a similar percentage felt the off-label drug use would increase the side-effects. Seventy three percent parents felt the off-label drug use is illegal and 57% would ask for change to a labelled drug in case of such prescription in their children. A majority of the parents would allow their child to participate in case of a life-threatening condition (59.8%) or in case of a chronic illness (51.3%) but significantly less when their child is healthy.
  
  
  CONCLUSIONS
  The present study has found a low level of awareness regarding the concept of off-label drug use in children amongst the public. Our study also shows that parents expect that the doctor explains the fact to them, although they appear to vest a large amount of trust in the doctor's judgement in doing the best for their sick child. Parents were more willing to allow their child's participation in clinical research if their child was seriously ill than if healthy, indicating the need to educate the society about the need for clinical research so that they could take more informed decisions.
authors.affiliation: Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Parel, Mumbai, India.
authors.forename: V
authors.initials: V
authors.lastname: Bang
authors.affiliation: Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Parel, Mumbai, India.
authors.forename: A
authors.initials: A
authors.lastname: Mallad
authors.affiliation: Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Parel, Mumbai, India.
authors.forename: S
authors.initials: S
authors.lastname: Kannan
authors.affiliation: Department of Pediatrics, TNMC and BYL Nair Hospital, Mumbai, India.
authors.forename: S B
authors.initials: SB
authors.lastname: Bavdekar
authors.affiliation: Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Parel, Mumbai, India.
authors.forename: N J
authors.initials: NJ
authors.lastname: Gogtay
authors.affiliation: Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Parel, Mumbai, India.
authors.forename: U M
authors.initials: UM
authors.lastname: Thatte
mesh_terms: D000293:Adolescent; D000328:Adult; D002986:Clinical Trials as Topic / Q000523:psychology*; D003142:Communication; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D064368:Healthy Volunteers / Q000523:psychology*; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D010290:Parents / Q000523:psychology*; D011368:Professional-Family Relations; D062606:Tertiary Care Centers; D055815:Young Adult
keywords: Awareness; children; clinical trials; off-label drug use; parents