Pharmacists' and Parents' Awareness and Attitudes Toward Off-Label Drug Prescribing in Pediatrics, Zawia (Libya)

Background: Off-label medicine prescriptions—where medications are used in a manner not specified in the official labeling—are commonly practiced across the globe, particularly in pediatric care. However, many of these prescriptions are made without adequate clinical evidence to support their safety and efficacy in children. Objective: This study aimed to assess and compare the knowledge, awareness, and perspectives of both pharmacists and parents regarding the off-label use of medications in pediatric patients. Methods: A descriptive cross-sectional survey was conducted over a three-month period, from January to March 2023, targeting pharmacists and parents residing in Al Zawia city. Data collection was carried out through a structured questionnaire, which was divided into two main sections: one for pharmacists and one for parents. The instrument was carefully designed based on prior validated studies and was translated into Arabic to facilitate comprehension and encourage prompt responses. The questionnaire collected both demographic information and opinions related to off-label drug use in children. A total of 150 participants were enrolled, including 100 parents and 50 pharmacists. The surveys were self-administered, with each taking approximately five minutes to complete. Participants were randomly selected to ensure a representative sample. Results: Analysis of the collected data revealed a relatively high level of awareness and understanding among both pharmacists and parents regarding the concept and implications of off-label drug use in pediatric populations. Pharmacists demonstrated a more in-depth knowledge, likely due to their professional background, while parents showed a basic yet important awareness of the subject. Most respondents expressed concerns about the lack of proper guidelines and scientific validation for such prescriptions. Conclusion: The findings suggest that there is a commendable level of knowledge and awareness among both pharmacists and parents concerning off-label prescribing for children. This highlights the importance of ongoing education, clear regulatory policies, and open communication between healthcare professionals and caregivers to ensure safe and effective pediatric pharmacotherapy.