Jacqueline Mpanga

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Country: Uganda
Background: Pharmacology
Research Project: The availability of paediatric antiretroviral formulations in Uganda

OBJECTIVE: To investigate the availability of age-appropriate antiretroviral (ARV) formulations for children receiving care at Baylor College of Medicine Children’s Foundation Uganda.
 
METHODOLOGY: A quantitative, cross-sectional design was employed.  2,496 prescriptions dispensed to 1,012 different children living with HIV were analysed retrospectively.  A summary of product characteristics for the ARVs in relation to paediatric use was tabulated to determine their licensing status.  Variables included ARV formulation, age category and licensing status.  Analysis was conducted using SPSS version 14 to establish the age category and ARVs that were lacking in terms of age-adapted formulations.  

RESULTS: 61% of the prescriptions were authorised while 39% were off-label and unlicensed combined. 
Over 50% off-label/unlicensed use occurred among prescriptions for tenofovir (TDF), the fixed-dose combination of zidovudine/lamivudine (AZT/3TC) and lopinavir/low-dose ritonavir (LPV/r). 
Prescriptions for solid formulations were characterised by more off-label/unlicensed use especially among children aged 6 -12 years.  

CONCLUSIONS: Some age-adapted ARVs existed but more were needed to boost access to universal paediatric ARV therapy.  It is recommended that pharmaceutical manufacturers step up research and development of age-adapted, paediatric ARV medicines particularly for children aged 6-12 years and to extend options beyond second-line medicines

KEY TERMS: Paediatric, Antiretroviral Formulations, Essential Medicines, Off-label, Unlicensed.