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Are pediatrics taking the prescribed tablet dosage form? Practices of off-label tablet modification in pediatric

Asmamaw Emagn Kasahun1, Ashenafi Kibret Sendekie2

  • 1Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.

Heliyon
|April 20, 2023
PubMed

Insights

Tablet manipulation for pediatric patients is common in Ethiopia due to unavailable appropriate doses. This practice leads to unlicensed dosage forms, impacting drug safety and bioavailability, necessitating evidence-based guidelines and varied dosage forms.

Area of Science:

  • Pharmaceutical Sciences
  • Pediatric Pharmacology
  • Drug Formulation

Background:

  • Tablet manipulation, including dose splitting and dispersion preparation, is frequently employed when suitable pediatric and neonatal dosage forms are unavailable.
  • This practice results in the use of unlicensed dosage forms, often outside regulatory approval, posing potential risks to vulnerable patient populations.

Purpose of the Study:

  • To assess the prevalence, nature, and appropriateness of off-label tablet manipulation in pediatric and neonatal wards.
  • To identify the types of drugs most commonly manipulated and potential issues arising from these manipulations.

Main Methods:

  • A prospective, direct observational study was conducted in two public hospitals in Ethiopia.
  • Data on tablet manipulations were collected from April 12 to June 30, 2021, focusing on pediatric and neonatal patients.

Main Results:

  • A total of 303 tablet manipulations were observed, with 69% involving dose splitting and 31% creating dispersions.
  • Manipulations of practically insoluble drugs (15.8%) and undissolved fractions in dispersions (12.5%) raise bioavailability and administration concerns.
  • Central nervous system and cardiovascular drugs were the most frequently manipulated.

Conclusions:

  • Off-label tablet manipulation is highly prevalent in Ethiopian pediatric age groups.
  • There is a critical need for evidence-based guidelines to enhance the safety of pediatric drug use.
  • Pharmaceutical manufacturers should develop a wider range of dosage forms to minimize the necessity for tablet manipulation.

Keywords:
DispersionNeonatalPediatricsSplittingTablet manipulations

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