Characteristics of prescription in 29 Level 3 Neonatal Wards over a 2-year period (2017-2018). An inventory for future research

Abstract

ObjectivesThe primary objective of this study is to determine the current level of patient medication exposure in Level 3 Neonatal Wards (L3NW). The secondary objective is to evaluate in the first month of life the rate of medication prescription not cited in the Summary of Product Characteristics (SmPC). A database containing all the medication prescriptions is collected as part of a prescription benchmarking program in the L3NW.Material and methodsThe research is a two-year observational cohort study (2017–2018) with retrospective analysis of medications prescribed in 29 French L3NW. Seventeen L3NW are present since the beginning of the study and 12 have been progressively included. All neonatal units used the same computerized system of prescription, and all prescription data were completely de-identified within each hospital before being stored in a common data warehouse.ResultsThe study population includes 27,382 newborns. Two hundred and sixty-one different medications (International Nonproprietary Names, INN) were prescribed. Twelve INN (including paracetamol) were prescribed for at least 10% of patients, 55 for less than 10% but at least 1% and 194 to less than 1%. The lowest gestational ages (GA) were exposed to the greatest number of medications (18.0 below 28 weeks of gestation (WG) to 4.1 above 36 WG) (p<0.0001). In addition, 69.2% of the 351 different combinations of an medication INN and a route of administration have no indication for the first month of life according to the French SmPC. Ninety-five percent of premature infants with GA less than 32 weeks received at least one medication not cited in SmPC.ConclusionNeonates remain therapeutic orphans. The consequences of polypharmacy in L3NW should be quickly assessed, especially in the most immature infants.

Review of Drug Utilization Studies in Neonatal Units: A Global Perspective

“…The mean and standard deviation (SD) of the number of drugs per infants received during neonatal care was reported in 14 studies [ 8 , 13 , 18 , 22 , 23 , 24 , 34 , 38 , 43 , 51 , 53 , 63 , 73 , 74 ] and sufficient information was available to impute the SD value in 7 other studies [ 19 , 28 , 32 , 39 , 42 , 69 , 75 ] ( Figure 3 ). The pooled mean (SD) of the number of drugs received per infant, calculated from data reported in 29 studies, was 4 (2.4) drugs.…”

“…Among the studies that used the WHO-ATC system, anti-infectives for systemic use were the most frequently prescribed pharmacological group in the majority (14 studies) [ 13 , 23 , 24 , 25 , 30 , 34 , 42 , 43 , 50 , 51 , 59 , 71 , 73 , 76 ]. This was followed by agents for the alimentary tract and metabolism (4 studies) [ 7 , 63 , 65 , 74 ] and agents for the central nervous system (1 study) (32). Among the four studies that listed the pharmacological groups according to their pharmacological class, three studies reported that antimicrobials were the most frequently prescribed group [ 19 , 39 , 47 ] and one study by Ashwin et al (2018) identified that penicillins were the most frequently prescribed [ 10 ].…”

“…Twenty-one studies reported a drug from another therapeutic class as its most frequently used. These were calcium gluconate (2 studies [ 7 , 8 ]), multivitamins (3 studies [ 44 , 65 , 75 ]), vitamin K (7 studies [ 14 , 22 , 43 , 45 , 55 , 62 , 76 ]), caffeine (2 studies [ 35 , 71 ]), chlorhexidine powder (1 study [ 37 ]), theophylline (1 study [ 42 ]), epinephrine (1 study [ 78 ]), parenteral nutrition (1 study [ 60 ]), cholecalciferol (1 study [ 63 ]), fentanyl (1 study [ 32 ]) and vitamin D (1 study [ 74 ]). Of the two studies that reported caffeine as the first most frequently prescribed drug, 86.8% of included infants in Cuzzolin et al (2016) were preterm [ 71 ] while Jong et al (2001) did not report the preterm proportion in their cohort [ 35 ].…”

“…Europe (24 studies) [7,13,20,25,26,29,31,35,37,[42][43][44]50,59,62,63,65,67,68,71,[74][75][76]79] caffeine (18 studies), gentamicin (17 studies), ampicillin (11 studies), furosemide (9 studies), multivitamins (9 studies), vitamin K (11 studies), benzylpenicillin (8 studies), amikacin (6 studies), morphine (5 studies), paracetamol (6 studies)…”

Antibiotics Prescription Over Three Years in a French Benchmarking Network of 23 Level 3 Neonatal Wards

“…Antibiotics overuse in neonatal wards (NWs) originates from the fear of overwhelming sepsis in an untreated infected baby, the lack of specific clinical and biological signs of neonatal infection, and the difficulty in obtaining efficient routine bacteriological examinations. These factors explain why up to 72% of neonates admitted to NICUs are given antibiotics and why this rate is the highest for the most immature babies, i.e., close to 100% in neonates with extremely low birth weight (ELBW, <1,000 g) or extremely low gestational age (ELGA, <27 weeks) ( Gouyon et al, 2019 ). These high rates are markedly in contrast with the scarcity of proven early-onset neonatal infection (EONI), which has been rated as low as 2.5% in symptomatic ELBW infants in the United States ( Puopolo et al, 2017 ) and at 2.3% in the United Kingdom ( Cailes et al, 2018 ).…”