Dosage Forms Suitability in Pediatrics: Acceptability of Antibiotics in a German Hospital
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Setting
2.2. Subjects
- Amoclav forte (co-amoxiclav) 250–62.5 mg/5 mL. Powder for oral suspension (Hexal®, Holzkirchen, Germany).
- Ceftriaxone 1 g (Hexal®, Holzkirchen, Germany) or 2 g (Hikma®, London, UK). Powder for suspension for injection.
- Ampicillin/sulbactam 1–0.5 g or 2–1 g. Powder for suspension for injection (Puren®).
- Ampicillin 0.5 g, 1 g or 2 g. Powder for suspension for injection (Ratiopharm®, Ulm, Germany).
- Refobacin (Gentamicin) 10 mg. Solution for injection (Merck®, Darmstadt, Germany).
2.3. Data Collection
2.4. Data Analysis
3. Results
3.1. Study Subject
3.2. Acceptability
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Observational Variables | Observed Measures (Categories) |
---|---|
Result intake The results of intake of the required dose | Fully, Partly, or Not taken |
Patient reaction The patient’s reaction to the intake on a 3-point facial hedonic scale | Positive, Neutral, or Negative reaction |
Preparation and administration time The time hospital staff needed to prepare (from opening the packaging to having the required dose of medication ready to use, including all handling and modifications) and administer the required dose of medication (from the required dose of medication ready to use to the end of the intake), pooled and recoded | Short (≤1′), Medium (from 1′ to 2′30″), or Long (>2′30″) time |
Divided dose Dividing the intake of a required dose which cannot be taken as a whole (e.g., successive sips of an oral liquid preparation, several tablets or pieces of tablets swallowed successively) | No divided dose, or Use divided dose |
Food/drink Using food/drink (e.g., mixing with the drug or taking before/after to mask the taste or ease swallowing) | No food/drink, or Use food/drink |
Alteration Altering the use, such as modifying the dosage form (e.g., prescribed dose of tablet split into fractions or crushed into powder) or using another route/mode of administration (e.g., oral administration of an injectable solution) | No alteration, or Use alteration |
Extra device Using a device not provided with the medication (e.g., disposable spoon or oral syringe provided with another medication) | No extra device, or Use extra device |
Reward Promising a reward | No reward, or Use reward |
Restraint The child was made to take it | No restraint, or Use restraint |
Characteristics | Amoclav Forte 250–62.5 mg/5 mL. Powder for Oral Suspension (n = 30) | Ceftriaxone 1 g|2 g. Powder for Suspension for Injection (n = 30) | Ampicillin/Sulbactam 1–0.5 g|2 g–1 g. Powder for Suspension for Injection (n = 30) | Ampicillin 0.5 g|1 g|2 g. Powder for Suspension for Injection (n = 30) | Refobacin 10 mg. Solution for Injection (n = 30) |
---|---|---|---|---|---|
Sex | |||||
Female | 16 (53) a | 18 (60) | 16 (53) | 9 (30) | 9 (30) |
Male | 14 (47) | 12 (40) | 14 (47) | 21 (70) | 21 (70) |
Age group | |||||
0–2 years | 17 (57) | 13 (43) | 15 (50) | 24 (80) | 24 (80) |
3–5 years | 7 (23) | 4 (13) | 4 (13) | 3 (10) | 2 (7) |
6–11 years | 3 (10) | 5 (17) | 2 (7) | 1 (3) | 2 (7) |
12–17 years | 3 (10) | 8 (27) | 9 (30) | 2 (7) | 2 (7) |
Parents Geographical regions of origin | |||||
Western Europe | 9 (30) | 13 (43) | 11 (37) | 11 (37) | 13 (43) |
Central and Eastern Europe | 7 (23) | 4 (13) | 7 (23) | 6 (20) | 6 (20) |
Mixed origin including Western | 5 (17) | 5 (17) | 4 (13) | 4 (13) | 3 (10) |
Europe | 3 (10) | 4 (13) | 1 (3) | 4 (13) | 2 (7) |
Western Europe (no information for other parent) | 3 (10) | 1 (3) | 2 (7) | 1 (3) | 1 (3) |
Other <5% b | 3 (10) | 3 (10) | 5 (17) | 4 (13) | 5 (17) |
Person in charge of the medicine administration | |||||
The patient | 6 (20) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
A caregiver c | 15 (50) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
A healthcare professional | 9 (30) | 30 (100) | 30 (100) | 30 (100) | 30 (100) |
Observer-Reported Outcomes | Amoclav Forte 250–62.5 mg/5 mL. Powder for Oral Suspension (n = 30) | Ceftriaxone 1 g|2 g. Powder for Suspension for Injection (n = 30) | Ampicillin/Sulbactam 1–0.5 g|2–1 g. Powder for Suspension for Injection (n = 30) | Ampicillin 0.5 g|1 g|2 g. Powder for Suspension for Injection (n = 30) | Refobacin 10 mg. Solution for Injection (n = 30) |
---|---|---|---|---|---|
Result intake | |||||
Fully taken | 28 (93) a | 30 (100) | 30 (100) | 30 (100) | 29 (97) |
Partly taken | 1 (3) | 0 (0) | 0 (0) | 0 (0) | 1 (3) |
Not taken | 1 (3) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Patient reaction | |||||
Positive | 5 (17) | 1 (3) | 0 (0) | 0 (0) | 0 (0) |
Neutral | 13 (43) | 7 (23) | 7 (23) | 5 (17) | 4 (13) |
Negative | 12 (40) | 22 (73) | 23 (77) | 25 (83) | 26 (87) |
Preparation and administration time | |||||
Short | 4 (13) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Medium | 5 (17) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Long | 21 (70) | 30 (100) | 30 (100) | 30 (100) | 30 (100) |
Divided dose | |||||
No divided dose | 24 (80) | 30 (100) | 30 (100) | 30 (100) | 29 (97) |
Use divided dose | 6 (20) | 0 (0) | 0 (0) | 0 (0) | 1 (3) |
Food/drink | |||||
No food/drink | 24 (80) | 30 (100) | 30 (100) | 30 (100) | 30 (100) |
Use food/drink | 6 (20) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Alteration | |||||
No alteration | 26 (87) | 30 (100) | 30 (100) | 30 (100) | 30 (100) |
Use alteration | 4 (13) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Extra device | |||||
No extra device | 16 (53) | 0 (0) | 1 (3) | 0 (0) | 0 (0) |
Use extra device | 14 (47) | 30 (100) | 29 (97) | 30 (100) | 30 (100) |
Reward | |||||
No reward | 30 (100) | 29 (97) | 28 (93) | 30 (100) | 29 (97) |
Use reward | 0 (0) | 1 (3) | 2 (7) | 0 (0) | 1 (3) |
Restraint | |||||
No restraint | 22 (73) | 18 (60) | 18 (60) | 12 (40) | 11 (37) |
Use restraint | 8 (27) | 12 (40) | 12 (40) | 18 (60) | 19 (63) |
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Klingmann, V.; Vallet, T.; Münch, J.; Wolters, L.; Stegemann, R.; Bosse, H.M.; Ruiz, F. Dosage Forms Suitability in Pediatrics: Acceptability of Antibiotics in a German Hospital. Antibiotics 2023, 12, 1709. https://doi.org/10.3390/antibiotics12121709
Klingmann V, Vallet T, Münch J, Wolters L, Stegemann R, Bosse HM, Ruiz F. Dosage Forms Suitability in Pediatrics: Acceptability of Antibiotics in a German Hospital. Antibiotics. 2023; 12(12):1709. https://doi.org/10.3390/antibiotics12121709
Chicago/Turabian StyleKlingmann, Viviane, Thibault Vallet, Juliane Münch, Lena Wolters, Robin Stegemann, Hans Martin Bosse, and Fabrice Ruiz. 2023. "Dosage Forms Suitability in Pediatrics: Acceptability of Antibiotics in a German Hospital" Antibiotics 12, no. 12: 1709. https://doi.org/10.3390/antibiotics12121709