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

• Published in: Journal of pharmaceutical health services research Vol. 10; no. 3; pp. 333 - 339
• Main Authors: Mukattash, Tareq L., Jarab, Anan S., Daradkeh, Aseel, Abufarha, Rana, AbuHammad, Sawsan H., AlRabadi, Nasr N.
• Format: Journal Article
• Language: English
• Published: London Wiley Subscription Services, Inc 01-09-2019
• Subjects: Arab; children; Children & youth; Clinical trials; Cross-sectional studies; off‐label medicines; parents; Parents & parenting; Pharmacists; Questionnaires; unlicensed medicines
• ISSN: 1759-8885; 1759-8893
• DOI: 10.1111/jphs.12293

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.