Inhaled pulmonary vasodilators for persistent pulmonary hypertension of the newborn: safety issues relating to drug administration and delivery devices

Nathan Cosa,1 Edward Costa Jr2 1Department of Respiratory Care, Banner Desert Medical Center, Cardon Children's Medical Center, Mesa, AZ, 2Department of Medical Affairs, Mallinckrodt Pharmaceuticals, Hampton, NJ, USA Abstract: Treatment for persistent pulmonary hypertension of the newborn (...

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Autores principales:	Cosa N, Costa E Jr
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	Nitric oxide prostaglandin E1 prostaglandin I2 nebulizers medical device safety phosphodiesterase-5 inhibitors Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/483058e58e7b48f687b1e780459d9d73
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spelling	oai:doaj.org-article:483058e58e7b48f687b1e780459d9d732021-12-02T05:12:17ZInhaled pulmonary vasodilators for persistent pulmonary hypertension of the newborn: safety issues relating to drug administration and delivery devices1179-1470https://doaj.org/article/483058e58e7b48f687b1e780459d9d732016-04-01T00:00:00Zhttps://www.dovepress.com/inhaled-pulmonary-vasodilators-for-persistent-pulmonary-hypertension-o-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Nathan Cosa,1 Edward Costa Jr2 1Department of Respiratory Care, Banner Desert Medical Center, Cardon Children's Medical Center, Mesa, AZ, 2Department of Medical Affairs, Mallinckrodt Pharmaceuticals, Hampton, NJ, USA Abstract: Treatment for persistent pulmonary hypertension of the newborn (PPHN) aims to reduce pulmonary vascular resistance while maintaining systemic vascular resistance. Selective pulmonary vasodilation may be achieved by targeting pulmonary-specific pathways or by delivering vasodilators directly to the lungs. Abrupt withdrawal of a pulmonary vasodilator can cause rebound pulmonary hypertension. Therefore, use of consistent delivery systems that allow for careful monitoring of drug delivery is important. This manuscript reviews published studies of inhaled vasodilators used for treatment of PPHN and provides an overview of safety issues associated with drug delivery and delivery devices as they relate to the risk of rebound pulmonary hypertension. Off-label use of aerosolized prostacyclins and an aerosolized prostaglandin in neonates with PPHN has been reported; however, evidence from large randomized clinical trials is lacking. The amount of a given dose of aerosolized drug that is actually delivered to the lungs is often unknown, and the actual amount of drug deposited in the lungs can be affected by several factors, including patient size, nebulizer used, and placement of the nebulizer within the breathing circuit. Inhaled nitric oxide (iNO) is the only pulmonary vasodilator approved by the US Food and Drug Administration for the treatment of PPHN. The iNO delivery device, INOmax DSIR®, is designed to constantly monitor NO, NO2, and O2 deliveries and is equipped with audible and visual alarms to alert providers of abrupt discontinuation and incorrect drug concentration. Other safety features of this device include two independent backup delivery systems, a backup drug cylinder, a battery that provides up to 6 hours of uninterrupted medication delivery, and 27 alarms that monitor delivery, dosage, and system functions. The ability of the drug delivery device to provide safe, consistent dosing is important to consider when selecting a pulmonary vasodilator. Keywords: nitric oxide, prostaglandin E1, prostaglandin I2, nebulizers, medical device safety, prostacyclinCosa NCosta E JrDove Medical PressarticleNitric oxideprostaglandin E1prostaglandin I2nebulizersmedical device safetyphosphodiesterase-5 inhibitorsMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2016, Iss Issue 1, Pp 45-51 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	Nitric oxide prostaglandin E1 prostaglandin I2 nebulizers medical device safety phosphodiesterase-5 inhibitors Medical technology R855-855.5
spellingShingle	Nitric oxide prostaglandin E1 prostaglandin I2 nebulizers medical device safety phosphodiesterase-5 inhibitors Medical technology R855-855.5 Cosa N Costa E Jr Inhaled pulmonary vasodilators for persistent pulmonary hypertension of the newborn: safety issues relating to drug administration and delivery devices
description	Nathan Cosa,1 Edward Costa Jr2 1Department of Respiratory Care, Banner Desert Medical Center, Cardon Children's Medical Center, Mesa, AZ, 2Department of Medical Affairs, Mallinckrodt Pharmaceuticals, Hampton, NJ, USA Abstract: Treatment for persistent pulmonary hypertension of the newborn (PPHN) aims to reduce pulmonary vascular resistance while maintaining systemic vascular resistance. Selective pulmonary vasodilation may be achieved by targeting pulmonary-specific pathways or by delivering vasodilators directly to the lungs. Abrupt withdrawal of a pulmonary vasodilator can cause rebound pulmonary hypertension. Therefore, use of consistent delivery systems that allow for careful monitoring of drug delivery is important. This manuscript reviews published studies of inhaled vasodilators used for treatment of PPHN and provides an overview of safety issues associated with drug delivery and delivery devices as they relate to the risk of rebound pulmonary hypertension. Off-label use of aerosolized prostacyclins and an aerosolized prostaglandin in neonates with PPHN has been reported; however, evidence from large randomized clinical trials is lacking. The amount of a given dose of aerosolized drug that is actually delivered to the lungs is often unknown, and the actual amount of drug deposited in the lungs can be affected by several factors, including patient size, nebulizer used, and placement of the nebulizer within the breathing circuit. Inhaled nitric oxide (iNO) is the only pulmonary vasodilator approved by the US Food and Drug Administration for the treatment of PPHN. The iNO delivery device, INOmax DSIR®, is designed to constantly monitor NO, NO2, and O2 deliveries and is equipped with audible and visual alarms to alert providers of abrupt discontinuation and incorrect drug concentration. Other safety features of this device include two independent backup delivery systems, a backup drug cylinder, a battery that provides up to 6 hours of uninterrupted medication delivery, and 27 alarms that monitor delivery, dosage, and system functions. The ability of the drug delivery device to provide safe, consistent dosing is important to consider when selecting a pulmonary vasodilator. Keywords: nitric oxide, prostaglandin E1, prostaglandin I2, nebulizers, medical device safety, prostacyclin
format	article
author	Cosa N Costa E Jr
author_facet	Cosa N Costa E Jr
author_sort	Cosa N
title	Inhaled pulmonary vasodilators for persistent pulmonary hypertension of the newborn: safety issues relating to drug administration and delivery devices
title_short	Inhaled pulmonary vasodilators for persistent pulmonary hypertension of the newborn: safety issues relating to drug administration and delivery devices
title_full	Inhaled pulmonary vasodilators for persistent pulmonary hypertension of the newborn: safety issues relating to drug administration and delivery devices
title_fullStr	Inhaled pulmonary vasodilators for persistent pulmonary hypertension of the newborn: safety issues relating to drug administration and delivery devices
title_full_unstemmed	Inhaled pulmonary vasodilators for persistent pulmonary hypertension of the newborn: safety issues relating to drug administration and delivery devices
title_sort	inhaled pulmonary vasodilators for persistent pulmonary hypertension of the newborn: safety issues relating to drug administration and delivery devices
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/483058e58e7b48f687b1e780459d9d73
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Inhaled pulmonary vasodilators for persistent pulmonary hypertension of the newborn: safety issues relating to drug administration and delivery devices

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