<p>Exploratory Findings of Prescribing Unlicensed and Off-Label Medicines Among Children and Neonates</p>

Abstract

Objective: A cross-sectional study was carried out to evaluate the practice of unlicensed and off-label drug prescribing/dispensing in children and neonates by physicians and clinical pharmacists in the metropolitan city of Karachi. Methods: The study was conducted for the duration of 5 months-November 2018 to March 2019in different clinics and tertiary care hospitals of Karachi, Pakistan. Respondents were interviewed by our researchers using 30 items questionnaire. Descriptive statistics were used to evaluate the answers of respondents to survey items. Pearson correlation and independent sample t-test were employed to recognize the association between the responses of participants and independent variables. P values less than 0.05 were considered statistically significant. Results: A total of 421 questionnaires were completed by physicians and clinical pharmacists. The mean age of the study participants was 49.5 years. Around 98% of pharmacists and 93.5% of physicians were well conversant with the definition of unlicensed and off-label drugs. Around 68% of physicians and 77% of pharmacists reported that they were more concerned about the efficacy of such drugs as compared to that of licensed medicines in children. The most frequent off-label categories observed in the study were dose (65.21%) and indication (17.52%). A vast majority (>80%) thought that approving new drugs by regulatory authorities will drop the occurrence of medication errors due to incorrect dosing. The British National Formulary (BNF) for children was used as the best reliable source of information among respondents. Conclusion: The present study highlighted the common practice of unlicensed and off-label drug prescribing in pediatrics; however, respondents showed their concern towards decreasing such practice and are likely to welcome initiatives intended to assure medication safety in children.

Medicamentos não licenciados: uma discussão em pediatria

“…A prescrição de medicamentos não licenciados é comum na população pediátrica hospitalizada em todo o mundo (Magalhães et al, 2015). Os estudos também apontam que a maioria dos medicamentos não licenciados são prescritos para os recém-nascidos, frequentemente para os nascidos pré-termo, isto é, aqueles que nasceram com menos de 37 semanas de idade gestacional (Shakeel et al, 2020;Kouti et al, 2019;Casañ et al, 2017;Gonçalves et al, 2017;Pereira et al, 2016;Souza et al, 2016;Corny et al, 2016;Magalhães et al, 2015). Contudo, devem ser considerados os riscos dessa prática para esse público, principalmente aqueles em Unidades de Terapia Intensiva Neonatal (UTIN), que apresentam quadro de maior vulnerabilidade em função da polimedicação, das doenças graves em bebês prematuros, do baixo peso ao nascer, entre outros aspectos (Casañ et al, 2017).…”

“…Estima-se que a probabilidade de ocorrência de reações adversas aos medicamentos é duas vezes maior em neonatos, uma vez que seu corpo é imaturo fisiologicamente (Shakeel et al, 2020;Aamir et al, 2018). Assim, a administração de medicamentos não licenciados pode ser mais insegura nesse grupo se comparada a outros perfis de pacientes (Shakeel et al, 2020;Kouti et al, 2019).…”

“…Os neonatos e as crianças possuem perfis farmacocinéticos e farmacodinâmicos distintos, implicando a necessidade de instituir o tratamento medicamentoso de forma personalizada (Shakeel et al, 2020;Tukayo et al, 2020;Landwehr et al, 2019;Aamir et al, 2018;Barker, 2018;Batchelor & Marriott, 2015).…”

“…Considerados como "órfãos terapêuticos", a lacuna de estudos clínicos e a definição terapêutica fragilmente articulada com as evidências científicas, contribui para o uso off label de medicamentos, assim como pode resultar maior consumo de medicamentos não licenciados em pediatria (Shakeel et al, 2020;Dornelles et al, 2019;Casañ et al, 2017;Pereira et al, 2016;Corney et al, 2016;Allen et al, 2018;Gonçalves et al, 2017;Nóbrega, Chagas & Magalhães, 2018). O uso off label e a utilização de medicamentos não licenciados é frequente em pediatria e com riscos associados, uma vez que esses produtos não foram devidamente estudados, podem resultar maior frequência de eventos adversos na população (Aamir et al, 2018;García-López et al, 2016;Batchelor & Marriott, 2015).…”

Gaps in Accessibility of Pediatric Formulations: A Cross-Sectional Observational Study of a Teaching Hospital in Northern Thailand

“…In a pediatric department of tertiary care hospitals in Pakistan, the prevalence of off-label medication use was 52.1 percent, while the prevalence of the unlicensed use of medicines was 33.4 percent [15]. This practice is common, although physicians and pharmacists acknowledge these issues [16,17]. Efficacy and safety are their major concerns [16,17].…”