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Off-Label Manipulation of Paediatric Medication Remains a Challenge in Clinical Practice: An Observational Study
Randi Hamre Svendsen1,2, Jennifer K N Andersen1,2, Sofia Kälvemark Sporrong3
1Hospital Pharmacies Enterprise, South-Eastern Norway, Oslo, Norway.
Aim:
The aim was to observe the methods used for off-label manipulation of medication on Norwegian paediatric wards.
Methods:
This prospective observational study used a digital form to collect information on how medicine was manipulated on five paediatric wards in four university and local hospitals, from October 2023 to May 2024.
Results:
We observed 31 off-label manipulations over 41 days. Tablets were the most frequently manipulated dosage form (71%). All tablets were manipulated by dispersing them in water, either to ease administration or to extract a partial paediatric dose. The tablets were dispersed whole or after splitting or crushing them. Most partial doses from tablets were difficult to achieve by splitting alone, as they were outside of half or quarter doses. There did not appear to be a standard routine for how to manipulate tablets, even when they had the same active pharmaceutical ingredients and target doses. Manipulation methods used did not always follow the available guidelines. Potentially hazardous medication was sometimes manipulated without adequate safety measures.
Conclusion:
The way that medication was manipulated varied and did not always follow the available guidelines. Safety procedures were not always followed when manipulating tablets.
Insights
Medication manipulation on Norwegian pediatric wards lacked standardization, with inconsistent adherence to guidelines. Safety measures were often insufficient, particularly when preparing pediatric doses from tablets.
Area of Science:
- Pediatric pharmacology
- Medication safety
- Pharmaceutical care
Background:
- Off-label medication manipulation is common in pediatric settings.
- Standardized protocols for manipulating medications are often lacking.
Purpose of the Study:
- To observe and document methods of off-label medication manipulation on Norwegian pediatric wards.
- To assess adherence to guidelines and safety procedures during medication manipulation.
Main Methods:
- Prospective observational study conducted on five pediatric wards across four hospitals.
- Data collected via a digital form over a 41-day period (October 2023 - May 2024).
Main Results:
- 31 instances of off-label medication manipulation were observed.
- Tablets (71%) were the most frequently manipulated dosage form, often dispersed in water for administration or dose extraction.
- Manipulation methods varied, lacked standardization, and did not consistently follow guidelines.
- Inadequate safety measures were noted, especially with potentially hazardous medications.
Conclusions:
- Significant variability exists in medication manipulation practices on pediatric wards.
- Current practices often deviate from established guidelines, posing potential risks.
- Enhanced focus on standardized procedures and safety protocols is crucial for pediatric medication management.
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