Dataset Information

Drug related problems in the neonatal intensive care unit: incidence, characterization and clinical relevance.

ABSTRACT:

Background

Any event involving drug therapy that may interfere in a patient's desired clinical outcome is called a drug related problem (DRP). DRP are very common in intensive therapy, however, little is known about DRP in the Neonatal Intensive Care Unit (NICU). The purpose of this study was to determine the incidence of DRPs in NICU patients and to characterize DRPs according to type, cause and corresponding pharmaceutical conducts.

Methods

Prospective observational study conducted in the NICU at a teaching hospital in Brazil from January 2014 to November 2016. The data were collected from the records of the clinical pharmacy service, excluding neonates admitted for less than 24 h and those who had no drugs prescribed. DRPs were classified according to the Pharmaceutical Care Network Europe system and evaluated for relevance-safety.

Results

Six hundred neonates were included in the study, with mean gestational age of 31.9 ± 4.1 weeks and mean birth weight of 1779 ± 885 g. The incidence of DRPs in the NICU was 6.8% patient-days (95%CI 6.2-7.3%) and affected 59.8% of neonates (95% CI 55.8-63.8%). Sub-optimal effect (52.8%) and inappropriate dose selection (39.75%) were the most common problem and cause, respectively. Anti-infectives was the medication class most involved in DRPs. More than one-third of neonates were exposed to DRP of significant or high safety-relevance. Most of the pharmaceutical interventions were related with drug prescription, with over 90% acceptance by attending physicians.

Conclusion

DRP are common in NICU, predominating problems of sub-optimal treatment, mainly due to inappropriate dose selection.

SUBMITTER: Leopoldino RD

PROVIDER: S-EPMC6485091 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Introduction: Drug-related problems (DRPs) incidence is higher in neonatal intensive care units (NICUs), compared to other pediatric wards due to aspects like off-label medications, pharmacokinetic/dynamic variability, or organ dysfunction/immaturity. This study aimed to determine whether and to what extent a clinical pharmacist intervention improves medication safety and prevents DRPs [medication errors (MEs), adverse drug reactions (ADRs), drug-drug interactions (DDIs)]. Methods: A prospective, randomized, double blind, controlled study in NICU-admitted neonates was conducted. NICU patients were randomly assigned to the intervention (clinical pharmacist-led) (IG) or control group (standard care such as clinical diagnosis, pharmacotherapy) (CG). The clinical pharmacist was involved in the IG to identify-prevent-intervene MEs, or identify and monitor ADRs and DDIs. The primary outcome was the number of neonates who developed at least one DRP compared with those seen across IG and CG. Secondary outcomes included length of hospital stay, total number of drugs or DRP type. Results: Neonates were randomly assigned to CG (n = 52) or IG (n = 48). In total, 45%, 42%, and 16% of patients had at least 1 MEs, ADRs, and clinically significant DDIs, respectively. The number of patients with at least 1 ME was 28 (53%) and 17 (35%) in the CG and IG (p>0.05). The median (range) number of ME was higher in CG [1 (0-7)] than in IG [0 (0-4)] (p = 0.003). Applying regression analysis, the CG had 2.849 times more MEs than the IG (p<0.001). Furthermore, the number of patients (CG to IG) with at least one detected ADR or clinical DDI was 19 (36%) to 23 (47%) (p>0.05) and 4 (7%) to 12 (25%), respectively (p = 0.028). Conclusion: Clinical pharmacist availability to systematically and standardized identify, prevent and resolve DRPs among NICU patients is effective. Daily detailed clinical pharmacist observations and interventions enables prevention and monitoring of DRPs. Clinical Trial Registration ClinicalTrials.gov, identifier NCT04899960.