ABSTRACT
BACKGROUND: An off-label medication involves the use of an approved drug for an unapproved indication, population, route of administration, or dosage.The physiological state of children differs from that of adults, making the adult formulation potentially dangerous to children. Off-label prescribing is quite common in children due to challenges in the development of pediatric formulations. The current study was conducted to determine the awareness, practice, and views of pediatricians, general physicians, and pharmacists about prescribing Off-label medication to pediatric patients in Eastern Province, Saudi Arabia. METHODS: A cross-sectional study based on a questionnaire was conducted among pediatricians, general physicians, and pharmacists (clinical and community) in Eastern Province, Saudi Arabia. Statistical analysis was conducted using the data exported from Google Forms (Mountain View, California, USA) and Microsoft Excel (Version 2016) and then exported into Statistical Package for Social Sciences (SPSS) version 26.0 (IBM, Inc., Armonk, NY, USA). Chi-square was deemed suitable. The level of significance was set at 0.05. RESULTS: Among the study participants, 53(35.09%) were pharmacists, followed by 24(15.89%) others, 22(14.565) pediatricians, 19(12.58%) other specialists, 17(11.25%) general physicians, and 16(10.59%) were clinical pharmacist. About 73(48.34%) described the definition of off-label correctly. About 114(75.49%) believed that parents and guardians must be informed about off-label medicine prescribed to their children. About 52(34.43%) had concerns about the safety of the medication, and 98(64.90%) believed they should be tested in pediatrics during clinical trials. Further, 97(64.23%) considered themselves not enough knowledgeable about off-label medications. The barriers reported by the participants were as follows: 89(58.945%) said lack of information resources, 71(47.01%) said lack of training, 56(37.08%) said lack of information on the safety of excipients used in pediatrics, 47(31.12%) said lack of formulary, 44(29.13%) said lack of guidelines, and 58(5.29%) said lack of information related to the safety of excipient concentration in pediatrics. The proportion of healthcare professionals who agreed that excipients in adult medication may be harmful to pediatrics was 103(68.21%). The drugs most often prescribed as off-label were paracetamol 54(21.68%), followed by Phenobarbital 35(14%), and Amoxicillin 33(13.25%). CONCLUSION: There are a considerable number of healthcare professionals unaware of the description of off-label medication. The majority have concerns over the safety and efficacy of the off-label drugs and believe that most frequently used off-label drugs in pediatrics must be tested in pediatrics during clinical trials. In addition, excipient safety data are of considerable importance to ensure off-label drug safety in pediatrics, who believe their knowledge is inadequate and need proper guidelines and training on this issue.
ABSTRACT
OBJECTIVES: To review the maternal and fetal outcome of triplet, quadruplet and quintuplet gestations following ART, which were managed at a hospital over 11 years. STUDY DESIGN: Retrospective chart review of 150 triplet, 27 quadruplet, and 6 quintuplet pregnancies between January 2001 and December 2011. 25 women aged 50-56 years with triplet pregnancies, were excluded due to lack of data. No prophylactic interventions were used. RESULTS: 300 triplets, 108 quadruplets, and 30 quintuplets were born. The mean maternal age was 30.2 years (SD 4.2 years). Mean gestational age delivery was 32.2 weeks (SD 4.2 weeks). Maternal complications included preterm labor 114 (86 %), prematurity 115 (87 %), anemia 44 (33 %) gestational diabetes 35 (27 %), preeclampsia 33 (25 %), post partum hemorrhage 13 (10 %). Preterm labor was diagnosed in 84 (84 %) triplets, 32 (97 %) of quadru- and quintuplet pregnancies (P > 0.05). Prematurity and preterm labor were major determinants. Of the 438 fetuses born there were 57 (13 %) still births, 77 (18 %) neonatal deaths. 32 (7 %) were early neonatal deaths, 45 (10 %) late neonatal deaths. The majority died due to extreme low birth weight. 75 (17 %) neonates had low apgar score of <7 at 5 min. 22 (5 %) infants had congenital anomalies. Severe respiratory distress syndrome, perinatal asphyxia, very early preterm delivery and perinatal mortality were higher in quadru- and quintuplets (P < 0.05). CONCLUSION: Preterm labor and preterm prematurity were the commonest complications. Neonatal mortality and morbidity was significantly increased in quadru- and quintuplets. Prophylactic interventions were not used in an attempt to prevent preterm labor.
