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Published on: March 30, 2014
Manipulation of solid dosage forms for oral administration to paediatric patients for drug-resistant tuberculosis in
Sheetal Harichander1, Varsha Bangalee2, Frasia Oosthuizen2
1School of Health Sciences, University of Kwazulu-Natal, Westville Campus, Private Bag X54001, Durban, 4000, South Africa. sheetal.harichander@gmail.com.
Insights
Drug-resistant tuberculosis (DR-TB) treatment in children faces challenges due to unavailable pediatric formulations, requiring medication manipulation. Developing child-friendly DR-TB drugs is crucial for better treatment outcomes.
Area of Science:
- Pediatric Pharmacology
- Infectious Diseases
- Global Health
Background:
- Children are vulnerable to drug-resistant tuberculosis (DR-TB), with 25,000-30,000 cases annually.
- Despite higher treatment success rates in children, they face unique diagnosis and treatment challenges.
- Drug-resistant TB in children includes multidrug-resistant TB (MDR-TB), pre-XDR-TB, and XDR-TB.
Purpose of the Study:
- To identify current practices for administering DR-TB drugs to children in South Africa.
- Focus on situations where appropriate pediatric dosage forms are unavailable.
Main Methods:
- An observational study was conducted in pediatric wards.
- Nursing staff practices for manipulating and administering prescribed medications were observed.
Main Results:
- Eight DR-TB drugs required formulation manipulation for pediatric administration.
- Only Linezolid and para-aminosalicylic acid are available in registered pediatric formulations in South Africa.
- Nurses cut capsules/tablets and dissolved contents to achieve correct pediatric doses.
Conclusions:
- Lack of suitable pediatric dosage forms leads to preparation time, prolonged administration, and unpalatability.
- These challenges can negatively impact patient compliance and therapeutic outcomes, especially for outpatients.
- Research and advocacy for child-friendly DR-TB drug formulations are essential for sustainable treatment supply.
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.
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