Paediatric oral dosage forms: Why do caregivers need drug modifications and how?
Year 2024,
Volume: 54 Issue: 3, 307 - 315, 30.12.2024
Özlem Akbal Dağıstan
,
Miray Arslan
,
Fevziye İşçi
,
Gamze Nur Temurtaş
Abstract
Background and Aims: A major obstacle to developing appropriate medications is the lack of understanding of what is acceptable for paediatric patients and the types of alterations that can be made to the dosage form. This study aimed to identify problems encountered when administering oral dosage forms to paediatric patients and solutions identified by patients’ caregivers.
Methods: A questionnaire was developed by the research team based on relevant literature and their experiences. The first part involves questions to determine the demographic characteristics of the paediatric patient and their caregivers. The second section includes 11 statements about the problems experienced by caregivers regarding the child’s medication use. The last part consists of 4 closed-ended questions and one open-ended question to evaluate the solutions offered by the patient’s caregivers.
Results: A total of 419 caregivers participated in the study. In particular, it has been revealed that children experience problems regarding the taste, smell, and size of medicines. When the caregivers’ solutions are evaluated, it was observed that the most common method is convincing or forcing the child to take, followed by dosage form alterations such as breaking, crushing, and dividing the form.
Conclusion: This is the first study to evaluate problems encountered when administering oral dosage forms to paediatric patients in Türkiye. The results show that the absence of age-appropriate medicines forces caregivers to alter their dosage forms. This study also highlights the necessity of considering user preferences in the dosage form design, which is an essential parameter of the target product quality profile that ensures patient compliance.
Ethical Statement
Ethics Committee Approval: The study was conducted with the permission decisions of the Van Governorship Provincial Health Directorate numbered 73040253-044-E.438 and the Van-Bitlis-Hakkari Chamber of Pharmacists with number 2019/1626 and the World Medical Association (WMA) Declaration of Helsinki Ethical Principles in Medical Research on Human Volunteers.
Supporting Institution
None
Thanks
The researchers would like to thank all respondents, who answered the questionnaire voluntarily.
References
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Year 2024,
Volume: 54 Issue: 3, 307 - 315, 30.12.2024
Özlem Akbal Dağıstan
,
Miray Arslan
,
Fevziye İşçi
,
Gamze Nur Temurtaş
References
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- Akram, G., & Mullen, A. B. (2012). Paediatric nurses’ knowledge and practice of mixing medication into foodstuff. International Journal of Pharmacy Practice, 20(3), 191-198. google scholar
- Alessandrini, E., Brako, F., Scarpa, M., Lupo, M., Bonifazi, D., Pignataro, V., . . . Tuleu, C. (2021). Children’s Preferences for Oral Dosage Forms and Their Involvement in Formulation Re-search via EPTRI (European Paediatric Translational Research Infrastructure). Pharmaceutics, 13(5). http://dx.doi.org/10.3390/ pharmaceutics13050730 google scholar
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- Kim, J., & De Jesus, O. (2023). Medication Routes of Administra-tion. In StatPearls. Treasure Island (FL): StatPearls Publishing Klingmann, V. (2017). Acceptability of Mini-Tablets in Young Children: Results from Three Prospective Cross-over Studies. AAPS PharmSciTech, 18(2), 263-266. http://dx.doi.org/10.1208/ s12249-016-0639-3 google scholar
- Kozarewicz, P. (2014). Regulatory perspectives on acceptability test-ing of dosage forms in children. International Journal of Phar-maceutics, 469(2), 245-248. http://dx.doi.org/10.1016/j.ijpharm. 2014.03.057 google scholar
- Lajoinie, A., Henin, E., Kassai, B., & Terry, D. (2014). Solid oral forms availability in children: a cost saving investigation. British Journal of Clinical Pharmacology, 78(5), 1080-1089. http://dx. doi.org/10.1111/bcp.12442 google scholar
- Liu, F., Ghaffur, A., Bains, J., & Hamdy, S. (2016). Acceptability of oral solid medicines in older adults with and without dysphagia: A nested pilot validation questionnaire based observational study. google scholar
International Journal of Pharmaceutics, 512(2), 374-381. http: //dx.doi.org/10.1016/j.ijpharm.2016.03.007 google scholar
- Marconati, M., Raut, S., Burbidge, A., Engmann, J., & Ramaioli, M. (2018). An in vitro experiment to simulate how easy tablets are to swallow. International Journal of Pharmaceutics, 535(1-2), 27-37. http://dx.doi.org/10.1016/j.ijpharm.2017.10.028 google scholar
- Nahata, M. C., & Taketomo, C. (2017). Pediatrics. In J. T. DiPiro, R. L. Talbert, G. C. Yee, G. R. Matzke, B. G. Wells, & L. M. Posey (Eds.), Pharmacotherapy: A Pathophysiologic Approach, 10e. New York, NY: McGraw-Hill Education. google scholar
- Nunn, T., & Williams, J. (2005). Formulation of medicines for chil-dren. British Journal of Clinical Pharmacology, 59(6), 674-676. http://dx.doi.org/10.1111/j.1365-2125.2005.02410.x google scholar
- Özkan, S., Kocaman, G., & Ozturk, C. (2013). Effect of strategies for preventing medication administration errors in pediatric in-patients. Turk Pediatri Arsivi, 48, 299-302. http://dx.doi.org/10. 4274/tpa.540 google scholar
- Patel, A., Jacobsen, L., Jhaveri, R., & Bradford, K. K. (2015). Effec-tiveness of pediatric pill swallowing interventions: a systematic re-view. Pediatrics, 135(5), 883-889. http://dx.doi.org/10.1542/peds. 2014-2114 google scholar
- Phillips, J., Beam, S., Brinker, A., Holquist, C., Honig, P., Lee, L. Y., & Pamer, C. (2001). Retrospective analysis of mortalities associ-ated with medication errors. American Journal of Health-System Pharmacy, 58(19), 1835-1841. http://dx.doi.org/10.1093/ajhp/58. 19.1835 google scholar
- Pirhan R. , Özcelikay G. (2005). Role of the pharmacist in pediatric medicine use. Journal of Faculty of Pharmacy of Ankara Univer-sity, 34(2), 95-105. google scholar
- Ranmal, S. R., Cram, A., & Tuleu, C. (2016). Age-appropriate and acceptable paediatric dosage forms: Insights into end-user perceptions, preferences and practices from the Chil-dren’s Acceptability of Oral Formulations (CALF) Study. International Journal of Pharmaceutics, 514(1), 296-307. http://dx.doi.org/10.1016/j.ijpharm.2016.07.054 google scholar
- Sanghera, I.S., Franklin, B.D. & Dhillon, S. (2007). The attitudes and beliefs of healthcare professionals on the causes and re-porting of medication errors in a UK Intensive care unit. Anes-thesia, 62(1),53-61. http://dx.doi.org/10.1111/j.1365-2044.2006. 04858.x google scholar
- Schiele, J. T., Quinzler, R., Klimm, H. D., Pruszydlo, M. G., & Haefeli, W. E. (2013). Difficulties swallowing solid oral dosage forms in a general practice population: prevalence, causes, and relationship to dosage forms. European Journal of Clinical Pharmacology, 69(4), 937-948. http://dx.doi.org/10.1007/s00228-012- 1417-0 google scholar
- Sears, K., O’Brien-Pallas, L., Stevens, B., & Murphy, G. T. (2013). The relationship between the nursing work environment and the occurrence of reported paediatric medication administration er-rors: A Pan Canadian study. Journal of Pediatric Nursing, 28(4), 351-356. https://doi.org/10.1016/j.pedn.2012.12.003 google scholar
- Shah, R. B., Collier, J. S., Sayeed, V. A., Bryant, A., Habib, M. J., & Khan, M. A. (2010). Tablet splitting of a narrow therapeutic index drug: a case with levothyroxine sodium. AAPS PharmSciTech, 11(3), 1359-1367. http://dx.doi.org/10.1208/s12249-010-9515-8 google scholar
- Stegemann, S., Ternik, R. L., Onder, G., Khan, M. A., & van Riet-Nales, D. A. (2016). Defining patient centric pharmaceutical drug product design. AAPS Journal, 18(5), 1047-1055. http://dx.doi. org/10.1208/s12248-016-9938-6 google scholar
- Stratton, K. M., Blegen, M. A., Pepper, G., & Vaughn, T. (2004). Reporting of medication errors by pediatric nurses. Journal of Pe-diatric Nursing, 19(6), 385-392. http://dx.doi.org/10.1016/j.pedn. 2004.11.007 google scholar
- Stucky, E. R. (2003). Prevention of medication errors in the pediatric inpatient setting. Pediatrics, 112(2), 431-436. http://dx.doi.org/10. 1542/peds.112.2.431 google scholar
- van Riet-Nales, D. A., de Jager, K. E., Schobben, A. F., Egberts, T. C., & Rademaker, C. M. (2011). The availability and age-appropriateness of medicines authorized for children in The Netherlands. British Journal of Clinical Pharmacology, 72(3), 465-473. http://dx.doi.org/10.1111/j.1365-2125.2011.03982.x google scholar
- van Riet-Nales, D. A., de Neef, B. J., Schobben, A. F., Ferreira, J. A., Egberts, T. C., & Rademaker, C. M. (2013). Acceptability of different oral formulations in infants and preschool children. Archives of Disease in Childhood, 98(9), 725-731. http://dx.doi. org/10.1136/archdischild-2012-303303 google scholar
- van Riet-Nales, D. A., Doeve, M. E., Nicia, A. E., Teerenstra, S., Notenboom, K., Hekster, Y. A., & van den Bemt, B. J. (2014). The accuracy, precision and sustainability of different techniques for tablet subdivision: breaking by hand and the use of tablet splitters or a kitchen knife. International Journal of Pharmaceutics, 466(1-2), 44-51. http://dx.doi.org/10.1016/j.ijpharm.2014.02.031 google scholar
- van Riet-Nales, D. A., Schobben, A. F., Egberts, T. C., & Rademaker, C. M. (2010). Effects of the pharmaceutical technologic aspects of oral pediatric drugs on patient-related outcomes: a systematic literature review. Clinical Therapeutics, 32(5), 924-938. http://dx. doi.org/10.1016/j.clinthera.2010.05.005 google scholar
- Venables, R., Batchelor, H., Stirling, H., & Marriott, J. (2016). Barriers to administering non-oral formulations in a paediatric population: A semi-structured interview study. International Journal of Phar-maceutics, 497(1-2), 12-17. http://dx.doi.org/10.1016/j.ijpharm. 2015.11.010 google scholar
- Walsh, J., Cram, A., Woertz, K., Breitkreutz, J., Winzenburg, G., Turner, R.,& Tuleu, C. (2014). Playing hide and seek with poorly tasting paediatric medicines: do not forget the excipients. Ad-vanced Drug Delivery Reviews, 73, 14-33. http://dx.doi.org/10. 1016/j.addr.2014.02.012 google scholar
- Walsh, J., Ranmal, S. R., Ernest, T. B., & Liu, F. (2018). Patient acceptability, safety and access: A balancing act for selecting age-appropriate oral dosage forms for paediatric and geriatric popula-tions. International Journal of Pharmaceutics, 536(2), 547-562. http://dx.doi.org/10.1016/j.ijpharm.2017.07.017 google scholar
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