Manipulation of solid dosage forms for oral administration to paediatric patients for drug-resistant tuberculosis in South Africa: an observation study.

BACKGROUND: Children represent a particularly vulnerable demographic in the context of drug-resistant (DR) tuberculosis (TB) due to their increased likelihood of close contact with adults diagnosed with the disease. Approximately 25 000-30 000 children develop DR-TB annually. While treatment success rates for DR-TB in children surpass those in adults, children and adolescents encounter distinct challenges throughout the diagnosis and treatment of DR-TB (including MDR-TB, Pre-XDR TB, and XDR-TB). AIM: To identify current practices in drug administration to children diagnosed with DR-TB where appropriate dosage forms are not available in South Africa. METHOD: An observational study was carried out at the study site to determine how medication prescribed was manipulated and administered by nursing staff to paediatric patients in the wards. RESULTS: The observational study identified 8 drugs used in DR-TB at the study site, where some manipulation to the formulation was necessary to enable administration to paediatric patients. Linezolid and para-aminosalicylic acid are the only drugs available and registered in the South Africa in a formulation that is suitable for administration to paediatric patients. Activities carried out by nursing staff to enable the administration of DR-TB medication included cutting capsules and tablets and dissolving the tablet or capsule contents in distilled water to obtain the required suitable dose. DISCUSSION: Lack of availability of suitable dosage forms for paediatrics patients results in several challenges, such as additional time required for drug preparation, increased time duration of medication administration, and unpalatability of drugs. These challenges may subsequently affect compliance and therapeutic outcomes of the treatment of paediatric patients, especially as outpatients. CONCLUSION: Research needs to focus on the development of appropriate dosage forms for the paediatric population and focus on identifying cases of DR-TB in children. This will assist in building evidence to advocate for registration of child-friendly dosage forms thereby ensuring a sustainable supply of medication.

The incidence of TB and MDR-TB in pediatrics and therapeutic options: a systematic review.

BACKGROUND: Tuberculosis (TB) is considered one of the top 10 causes of death worldwide and the leading cause of death from a single infectious agent. Multidrug-resistant (MDR) TB can affect people of all age groups, including children (aged 0-15 years). However, very little is known about the extent of this problem in children. This systematic review aims to investigate the incidence of TB and drug-resistant (DR) TB among the pediatric population. It also reviews the therapeutic options available to treat the condition. METHODS: A comprehensive search for all relevant evidence was conducted. The following databases were searched: MEDLINE, CINAHL, and Web of Science. The searched time frame was limited from January 1990 to December 2020 with a focus on the incidence of TB and MDR-TB among pediatrics and the therapeutic options available. RESULTS: A total of 537 articles were obtained via the selected databases. After title and abstract screening, 418 articles were excluded leaving 119 articles. Full-text screening was conducted on 119 articles, excluding a further 110 articles. Thus, 9 articles were subject to quality assessment and included in this review. The 9 articles represented the age group of 0-15 years and included both males and females. All studies included were of retrospective study design. DISCUSSION: The included studies mentioned a moderate increase in TB cases among pediatrics exacerbated by malnutrition, lack of bacille Calmette-Guérin (BCG) vaccination, and human immunodeficiency virus (HIV) coinfection. MDR-TB prevalence was especially high in South Africa. Drug therapy for both TB and MDR-TB yielded favorable outcomes among pediatrics. However, one of the biggest challenges with drug therapy includes the dosage forms available. SYSTEMATIC REVIEW REGISTRATION: DOI: 10.17605/OSF.IO/G34NF.