A review of excipient levels in paediatric intensive care unit (PICU) patients

C.A. Langley, S. Sultana, R. Isaac

Research output: Contribution to journalMeeting abstract

Abstract

Introduction: Most drugs cannot be delivered in isolation and therefore require excipients to ensure suitability of the dosage form. Excipients can cause unwanted effects; however the quantity of excipients in products is not commonly accounted for during prescribing. Paediatric patients are particularly vulnerable to the potential toxic effects of excipients, especially those in intensive care settings. The aim of this study was to identify and quantify the excipients included in the medications administered to a selection of patients from the Paediatric Intensive Care Unit (PICU) at Birmingham Children’s Hospital.
Materials & Methods Design: Data were collected from five randomly selected patients. Manufacturers were contacted to ascertain excipient quantities present. Setting: Paediatric Intensive Care Unit (PICU), Birmingham Children’s Hospital, UK.
Main outcome measures: Identity and quantity of excipients administered.
Results: In total, twenty-seven manufacturers were contacted, and two-thirds (67%, n = 18/27) responded to the information request. Overall (excluding intravenous fluids), the patients were taking 49 medicines; however, it was only possible to find out the details for all of the excipients present for 22% (n = 11/49) of products, with details for selected excipients provided for 31% (n = 15/49) of products. Although in-depth analysis of the excipients could not be carried out due to the limited response from the manufacturers, it was still evident that some patients were receiving potentially toxic excipient doses. For example, one multi-syndrome infant was receiving five times the WHO recommended maximum daily amount of propylene glycol a day, from one medicinal product.
Discussions, Conclusion: The lack of readily available information from manufacturers on excipients and their quantities is worrying. This small study has indicated that some paediatric patients receive potentially toxic levels of selected excipients. For example, excessive propylene glycol can cause ototoxicity, nephrotoxicity, lactic acidosis and seizure in children. Therefore, it is vital that excipients are monitored in PICU patients and information on excipient quantities should be readily available for practitioners to refer to when required.
Disclosure of Interest: None Declared.
LanguageEnglish
Article numberIDMD-029
Pages167
Number of pages1
JournalInternational Journal of Clinical Pharmacy
Volume34
Issue number1
Early online date8 Jan 2012
Publication statusPublished - Feb 2012
EventESCP 40th International Symposium on Clinical Pharmacy: Clinical pharmacy: connecting care and outcomes - Dublin, Ireland
Duration: 19 Oct 201121 Oct 2011

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Intensive care units
Pediatric Intensive Care Units
Pediatrics
Excipients
Poisons
Propylene Glycol
Lactic Acidosis
Dosage Forms
Disclosure
Critical Care

Bibliographical note

Abstracts

Cite this

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title = "A review of excipient levels in paediatric intensive care unit (PICU) patients",
abstract = "Introduction: Most drugs cannot be delivered in isolation and therefore require excipients to ensure suitability of the dosage form. Excipients can cause unwanted effects; however the quantity of excipients in products is not commonly accounted for during prescribing. Paediatric patients are particularly vulnerable to the potential toxic effects of excipients, especially those in intensive care settings. The aim of this study was to identify and quantify the excipients included in the medications administered to a selection of patients from the Paediatric Intensive Care Unit (PICU) at Birmingham Children’s Hospital. Materials & Methods Design: Data were collected from five randomly selected patients. Manufacturers were contacted to ascertain excipient quantities present. Setting: Paediatric Intensive Care Unit (PICU), Birmingham Children’s Hospital, UK. Main outcome measures: Identity and quantity of excipients administered. Results: In total, twenty-seven manufacturers were contacted, and two-thirds (67{\%}, n = 18/27) responded to the information request. Overall (excluding intravenous fluids), the patients were taking 49 medicines; however, it was only possible to find out the details for all of the excipients present for 22{\%} (n = 11/49) of products, with details for selected excipients provided for 31{\%} (n = 15/49) of products. Although in-depth analysis of the excipients could not be carried out due to the limited response from the manufacturers, it was still evident that some patients were receiving potentially toxic excipient doses. For example, one multi-syndrome infant was receiving five times the WHO recommended maximum daily amount of propylene glycol a day, from one medicinal product. Discussions, Conclusion: The lack of readily available information from manufacturers on excipients and their quantities is worrying. This small study has indicated that some paediatric patients receive potentially toxic levels of selected excipients. For example, excessive propylene glycol can cause ototoxicity, nephrotoxicity, lactic acidosis and seizure in children. Therefore, it is vital that excipients are monitored in PICU patients and information on excipient quantities should be readily available for practitioners to refer to when required. Disclosure of Interest: None Declared.",
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A review of excipient levels in paediatric intensive care unit (PICU) patients. / Langley, C.A.; Sultana, S.; Isaac, R.

In: International Journal of Clinical Pharmacy, Vol. 34, No. 1, IDMD-029, 02.2012, p. 167.

Research output: Contribution to journalMeeting abstract

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AU - Isaac, R.

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N2 - Introduction: Most drugs cannot be delivered in isolation and therefore require excipients to ensure suitability of the dosage form. Excipients can cause unwanted effects; however the quantity of excipients in products is not commonly accounted for during prescribing. Paediatric patients are particularly vulnerable to the potential toxic effects of excipients, especially those in intensive care settings. The aim of this study was to identify and quantify the excipients included in the medications administered to a selection of patients from the Paediatric Intensive Care Unit (PICU) at Birmingham Children’s Hospital. Materials & Methods Design: Data were collected from five randomly selected patients. Manufacturers were contacted to ascertain excipient quantities present. Setting: Paediatric Intensive Care Unit (PICU), Birmingham Children’s Hospital, UK. Main outcome measures: Identity and quantity of excipients administered. Results: In total, twenty-seven manufacturers were contacted, and two-thirds (67%, n = 18/27) responded to the information request. Overall (excluding intravenous fluids), the patients were taking 49 medicines; however, it was only possible to find out the details for all of the excipients present for 22% (n = 11/49) of products, with details for selected excipients provided for 31% (n = 15/49) of products. Although in-depth analysis of the excipients could not be carried out due to the limited response from the manufacturers, it was still evident that some patients were receiving potentially toxic excipient doses. For example, one multi-syndrome infant was receiving five times the WHO recommended maximum daily amount of propylene glycol a day, from one medicinal product. Discussions, Conclusion: The lack of readily available information from manufacturers on excipients and their quantities is worrying. This small study has indicated that some paediatric patients receive potentially toxic levels of selected excipients. For example, excessive propylene glycol can cause ototoxicity, nephrotoxicity, lactic acidosis and seizure in children. Therefore, it is vital that excipients are monitored in PICU patients and information on excipient quantities should be readily available for practitioners to refer to when required. Disclosure of Interest: None Declared.

AB - Introduction: Most drugs cannot be delivered in isolation and therefore require excipients to ensure suitability of the dosage form. Excipients can cause unwanted effects; however the quantity of excipients in products is not commonly accounted for during prescribing. Paediatric patients are particularly vulnerable to the potential toxic effects of excipients, especially those in intensive care settings. The aim of this study was to identify and quantify the excipients included in the medications administered to a selection of patients from the Paediatric Intensive Care Unit (PICU) at Birmingham Children’s Hospital. Materials & Methods Design: Data were collected from five randomly selected patients. Manufacturers were contacted to ascertain excipient quantities present. Setting: Paediatric Intensive Care Unit (PICU), Birmingham Children’s Hospital, UK. Main outcome measures: Identity and quantity of excipients administered. Results: In total, twenty-seven manufacturers were contacted, and two-thirds (67%, n = 18/27) responded to the information request. Overall (excluding intravenous fluids), the patients were taking 49 medicines; however, it was only possible to find out the details for all of the excipients present for 22% (n = 11/49) of products, with details for selected excipients provided for 31% (n = 15/49) of products. Although in-depth analysis of the excipients could not be carried out due to the limited response from the manufacturers, it was still evident that some patients were receiving potentially toxic excipient doses. For example, one multi-syndrome infant was receiving five times the WHO recommended maximum daily amount of propylene glycol a day, from one medicinal product. Discussions, Conclusion: The lack of readily available information from manufacturers on excipients and their quantities is worrying. This small study has indicated that some paediatric patients receive potentially toxic levels of selected excipients. For example, excessive propylene glycol can cause ototoxicity, nephrotoxicity, lactic acidosis and seizure in children. Therefore, it is vital that excipients are monitored in PICU patients and information on excipient quantities should be readily available for practitioners to refer to when required. Disclosure of Interest: None Declared.

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SN - 2210-7703

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