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- Title
Pharmacoepidemiological evaluation of off label and unlicensed prescription in pediatric intensive care units at tertiary care hospitals of Peshawar, Pakistan.
- Authors
Aamir, Muhammad; Shah, Muhammad Abid; Kauser, Tabassum Naheed; Khan, Nouman; Mehmood, Irum; Khan, Jamshaid Ali; Iqbal, Waheed
- Abstract
Population of pediatric intensive care units are at high risk of receiving off label and unlicensed drug use. Little is known about the characteristics and prevalence of unlicensed and off label prescriptions in pediatric intensive care units (PICUs) at tertiary care settings of Pakistan. Case notes of 420 children were reviewed for unlicensed and off label prescriptions during the one year. Medication profiles were assessed using Micromedex. Logistic regression was applied to calculate the odds-ratios for predictors of unlicensed and off label prescriptions. of the total prescriptions, 29.8% prescriptions were unlicensed from FDA and 42.27% prescriptions were off labelled. Dose (32.79%) was the most common reason for off label prescriptions followed by the indication (26.13%) and indication-dose (13.98%). Multivariate regression analysis revealed no significant association between the unlicensed prescriptions with their predictors. In reference to corresponding category, prescribed medications less than 5 (OR 0.280, 95%CL 0.137-0.570) were significantly less likely to receive off label prescriptions as compared to patients received 6 or more medications. Substantial numbers of children are exposed to unlicensed and off label prescriptions. Standards of drug quality, safety and efficacy should apply equally in adults and in pediatrics under ethical perspective. Suitable clinical interventions must be established by drug manufactures and government agencies for improved pediatric pharmacotherapy.
- Subjects
PAKISTAN; PESHAWAR (Pakistan); PEDIATRIC intensive care; INTENSIVE care units; UNITED States. Food &; Drug Administration; PHARMACOEPIDEMIOLOGY; HOSPITAL care; TERTIARY care
- Publication
Pakistan Journal of Pharmaceutical Sciences, 2023, Vol 36, Issue 1, p81
- ISSN
1011-601X
- Publication type
Article
- DOI
10.36721/PJPS.2023.36.1.REG.081-087.1