Parental views and attitudes towards use of unlicensed and off-label medicines in children and paediatric clinical trials: an online cross-sectional study in the Arab world

Abstract

Objectives: The present study aimed to explore views and attitudes of parents towards the use of unlicensed and off-label medicines in children, paediatric clinical trials, and the role of pharmacists in the safety and effectiveness of medicines. Methods: A cross-sectional electronic survey was conducted over social media networks in the Arab world to assess parents’ views and attitude towards use of unlicensed/off-label medicines and clinical trials in children. Validated questionnaire was adopted to achieve the study goals. Key findings: A total of 4740 respondents completed the online questionnaire. 55.2% have no previous knowledge of use of unlicensed medicines in children. Most of parents thought that they should be told about the use of such medicines, with the doctor (55.0%) selected as the person who should tell parents. Respondents thought that the use of medicines in children was extremely safe or safe. However, this proportion is decreased dramatically (P < 0.001; McNemar test). Views of parents towards clinical trials vary according to child health (child in good health 14.8% versus child suffering of life-threatening condition 50.4%). The majority of respondents thought that pharmacist has a significant role in assuring the safety and efficacy of medicines. Conclusions: Limited parents’ knowledge about the use of medicines in children and the importance of clinical trials. General consensus about pharmacists’ role in ensuring medicines’ safety and efficacy.