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Infant acceptance and effectiveness of a new oral liquid medication delivery system
D M Kraus1, L A Stohlmeyer, P R Hannon
1Department of Pharmacy Practice, College of Pharmacy, University of Illinois at Chicago, 60612, USA. dkraus@uic.edu
Insights
A new pediatric medication acceptance scale (MAS) effectively measured infant drug acceptance. The Rx medibottle system demonstrated high infant and rater acceptance, ensuring accurate dosing.
Area of Science:
- Pediatric Pharmacology
- Drug Delivery Systems
- Clinical Trial Methodology
Background:
- Assessing infant acceptance of oral liquid medications is challenging.
- Existing methods may not fully capture infant responses during administration.
- A validated tool is needed to evaluate medication delivery systems.
Purpose of the Study:
- To develop and validate a Medication Acceptance Scale (MAS) for pediatric oral liquids.
- To evaluate the effectiveness and infant acceptance of the Rx medibottle medication delivery system.
- To assess the reliability and validity of the newly developed MAS.
Main Methods:
- Development of a MAS incorporating five behavioral elements (cry, facial expression, agitation, oral reaction, swallowing).
- Open-label clinical study administering acetaminophen to 20 infants using the Rx medibottle.
- Independent scoring of infant acceptance by nurses and pharmacists, alongside dose and time measurements.
Main Results:
- The MAS demonstrated high internal consistency and interrater reliability.
- 80% of infants received 100% of the intended dose.
- High median MAS scores (9) indicated significant infant acceptance; strong correlation with global acceptance scales.
Conclusions:
- A valid and reliable pediatric oral liquid MAS was successfully developed.
- The Rx medibottle is an effective medication delivery system with high infant and rater acceptance.
- The MAS provides a robust measure for evaluating pediatric medication administration tools.
Abstract:
A medication acceptance scale (MAS) for pediatric oral liquids was developed and used to evaluate effectiveness and infant acceptance of a medication delivery system. The MAS incorporated five behavioral elements associated with pediatric drug administration: cry, facial expression, body movement or level of agitation, reaction to placement of medication in the mouth, and swallowing. A score of 1-10 was possible, with 10 indicating the highest level of infant acceptance. Preliminary field testing was conducted. In an open-label clinical study, a single dose of acetaminophen was administered to 20 infants with approximately one fluid ounce of infant formula or apple juice by pediatric nurses using the Rx medibottle (The Medicine Bottle Company). Past medication acceptance was rated on an infant global acceptance scale. The intended dose, the amount consumed, and the time taken to administer the dose were recorded. Infant acceptance was independently scored by a nurse and two pharmacists. A high preliminary estimate of internal consistency reliability of the MAS was found. Interrater reliability was high, with the highest correlation between the two pharmacists. Sixteen (80%) of the infants received 100% of the intended dose; it took 0.5-9 minutes to administer these doses. The median MAS score was 9 for each of the three raters. Mean MAS scores for the three raters were 7.85 and 7.45 (pharmacists) and 8.50 (nurse). There was a strong correlation between MAS scores and infant global acceptance scale scores. A pediatric oral liquid MAS that had content validity, concurrent validity, high internal consistency reliability, and high interrater reliability was developed; the Rx medibottle was an effective oral liquid medication delivery system and had a high level of infant and rater acceptance.