Predictors for drug utilization and drug related problems in hospitalized neonates / Rosliana Rosli

Despite complex pharmacotherapy management in neonates, the epidemiology of drug utilization, drug related problems (DRPs) and their predictors in hospitalized neonates in Malaysia are unknown. Thus, the aims of this study were to examine the drug utilization profile, DRPs and their predictors in hospitalized neonates. A systematic review was conducted prior to the actual study to determine the prescribing patterns and methodologies used for reporting drug utilization in hospitalized neonates. Two projects were undertaken under this study. Project I was conducted at Hospital Sultanah Aminah, Johor Bahru. Project I was carried out in Medical Record Office (retrospective) and neonatal intensive care unit (NICU) and neonatal wards (prospective). Patients' medication charts, ward notes and laboratory data were reviewed daily and progress of the selected patients in the ward were documented. Logistic regression was used to analyse potential risk factors associated with use of > 5 drugs and DRPs occurrence. As Adverse Drug Reaction (ADR) is a subset of DRPs, Project II was carried out at National Pharmaceutical Regulatory Agency (NPRA) using the data from the national pharmacovigilance database, QUEST2 system to examine the characteristics and prevalence of ADRs in neonates in contrast to other paediatric population. The systematic review revealed that neonates are exposed to a high number of drugs, with antiinfectives for systemic use being the most predominantly prescribed. Various methods have been used to quantify drug consumption in neonates but no study from Malaysia was identified. In project I, a total of 302 neonates were included in the study. The majority of neonates admitted to NICU and neonatal wards were preterm (63.2%, n=191) and LBW infants (64.6%, n=195). On average, the neonates were admitted for 28.4 days and there were 2715 drugs documented. Antiinfectives for systemic use (n=1235, 45.5%) were the most commonly prescribed drugs, with benzylpenicillin (n=293) and gentamicin (n=275) being the most predominant. Number of diagnoses or problems was found to be a significant predictors for neonates to be prescribed with > 5 drugs. In total, 768 DRPs were identified for 265 patients, whom had at least one DRP. The overall incidence of DRPs was 87.7% and treatment safety which relates to adverse drug events had the highest frequency amongst the reported problems, 67.1% (n=515). A retrospective analysis of ADRs reports received by the national pharmacovigilance centre in project II found that antibacterial for systemic use were commonly associated with ADRs in Malaysian children with majority of them manifested through skin reactions. ADRs reported for neonates was lower than other children age categories. Inappropriate dose, 60.0% (n=572) and drug selection 21.4% (n=204) were the common causes for DRPs identified. The number of drugs prescribed was the only potential risk factor that was found to be significant for the occurrence of DRPs. Neonates are exposed to high number of drugs and are at risk of developing DRPs. Pharmacists should set priority for the preterm and LBW neonates who have multiple diagnoses and prescribed with multiple drugs in order to minimize the risks of DRPs and subsequently improve efficiency of clinical pharmacy services

A Retrospective Analysis of Spontaneous Adverse Drug Reactions Reports Relating to Paediatric Patients.

BACKGROUND:Spontaneous reporting on adverse drug reactions (ADR) has been established in Malaysia since 1987, and although these reports are monitored by the Malaysia drug monitoring authority, the National Pharmaceutical Control Bureau, information about ADRs in the paediatric patient population still remains unexplored. The aims of this study, therefore, were to characterize the ADRs reported in respect to the Malaysian paediatric population and to relate the data to specific paediatric age groups. METHODS:Data on all ADRs reported to the National Pharmaceutical Control Bureau between 2000 and 2013 for individuals aged from birth to 17 years old were analysed with respect to age and gender, type of reporter, suspected medicines (using the Anatomical Therapeutic Chemical classification), category of ADR (according to system organ class) as well as the severity of the ADR. RESULTS:In total, 11,523 ADR reports corresponding to 22,237 ADRs were analysed, with half of these reporting one ADR per report. Vaccines comprised 55.7% of the 11,523 ADR reports with the remaining being drug related ADRs. Overall, 63.9% of ADRs were reported for paediatric patients between 12 and 17 years of age, with the majority of ADRs reported in females (70.7%). The most common ADRs reported were from the following system organ classes: application site disorders (32.2%), skin and appendages disorders (20.6%), body as a whole general disorders (12.8%) and central and peripheral nervous system disorders (11.2%). Meanwhile, ADRs in respect to anti-infectives for systemic use (2194/5106; 43.0%) were the most frequently reported across all age groups, followed by drugs from the nervous system (1095/5106; 21.4%). Only 0.28% of the ADR cases were reported as fatal. A large proportion of the reports were received from healthcare providers in government health facilities. DISCUSSION:ADR reports concerning vaccines and anti-infectives were the most commonly reported in children, and are mainly seen in adolescents, with most of the ADRs manifesting in skin reactions. The majority of the ADR reports were received from nurses in the public sector, reporting ADRs associated with vaccine administration. The low fatality rate of ADR cases reported could potentially be caused by reporting bias due to the very low reporting percentage from the private healthcare institutions. This study indicates that ADR rates among Malaysian children are higher than in developed countries. Constant ADR reporting and monitoring, especially in respect to paediatric patients, should be undertaken to ensure their safety

ADRs for drugs distributed by therapeutic group and age groups.

<p>ADRs for drugs distributed by therapeutic group and age groups.</p

System organ class for vaccines and drugs according to age group.

<p>System organ class for vaccines and drugs according to age group.</p

ADRs by common therapeutic groups (ATC Level 2) and age groups.

<p>ADRs by common therapeutic groups (ATC Level 2) and age groups.</p

Flow chart of methodology and ADR reports included in the present study.

<p>Flow chart of methodology and ADR reports included in the present study.</p

Characteristics of fatal ADRs.

<p>Characteristics of fatal ADRs.</p