Temperature-sensitive Medications in Interfacility Transport: The Ice Pack Myth

Clancy, Jason; Karish, Cassandra; Roddy, Meghan; Sicilia, Judith J.; Bigham, Michael T.

doi:10.1016/j.amj.2017.05.002

Cited by 10 publications

(10 citation statements)

References 10 publications

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“…When products experience temperature excursions, the risk adverse approach from the end-user perspective is to remove the product from the supply chain. Although the modeling has been focused on pharmaceuticals, temperature excursion also can occur for medical equipment, vaccines, veterinary medicines, and diagnostics [ 23 – 26 ], where risk mitigation efforts and assessments employed can also apply to pharmaceuticals. To further mitigate risk to the end user, programs may consider using cold chain approaches (commonly applied to vaccines) [ 27 , 28 ] or explore other temperature-controlled transportation options [ 29 ], if the commodity is extremely temperature sensitive.…”

Section: Discussionmentioning

confidence: 99%

Mean kinetic temperature evaluations through simulated temperature excursions and risk assessment with oral dosage usage for health programs

2022

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Background Temperature excursions occur during the transport and storage of pharmaceuticals, and often result in considerable losses for public health programs operating in countries with limited resources. After a temperature excursion has been identified, often products are discarded without any additional risk assessments. Consulting the manufacturer is the preferred approach but can be challenging depending on the responsiveness of the manufacturer. However, decisions are often required quickly depending on program needs and available stock in country. Methods To provide further guidance, simulations have been conducted based on mean kinetic temperature evaluations using accepted default kinetic parameters to assess loss of shelf-life for scenarios involving various levels of temperature excursions on a model pharmaceutical at different recommended storage conditions, shelf-life, and long-term storage conditions. Results Although an immediate loss to shelf-life occurred with excursions when the product was stored at the maximum allowed temperature, more extended excursion could be withstood before loss of shelf-life was detected when long-term storage was maintained at temperatures below the maximum storage condition for the product. With the assumption that a shelf-life loss of 2 weeks was negligible when managing program stock, a risk assessment was conducted to outline the various times that excursions at different temperatures could be considered low risk to the program. Conclusions Depending on the level of the temperature excursion and the guidance provided by the manufacturer, public health programs will have further information with this assessment to guide decisions that impact safety to the end user and resource management due to temperature excursions that can occur.

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Section: Discussionmentioning

confidence: 99%

Mean kinetic temperature evaluations through simulated temperature excursions and risk assessment with oral dosage usage for health programs

2022

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“…Clancy et al found that the industry-accepted passive refrigeration was ineffective for temperature-sensitive medication transport and resulted in significant temperature excursions for trip durations lasting greater than 3 hours. 15 Utilizing thermal control technology, Krook et al reported only 1.2% of unit wastage during a four-year review of prehospital blood transfusion within a Canadian helicopter emergency medical service. 11 Blood is a valuable resource that is often in short supply.…”

Section: Discussionmentioning

confidence: 99%

Decreasing Blood Wastage During Ex Vivo Lung Perfusion Recovery Through Utilization of Thermal Control Technology

Johnson

Bucio

Salerno

et al. 2022

Preprint

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Background The Organ Care System (OCS) is a revolutionary ex vivo organ perfusion technology that can potentially expand the organ retrieval range. The OCS Lung device uses packed red blood cells (pRBC) with a proprietary solution. We report the ability to reduce blood waste during this procedure by using a thermal packaging solution in conjunction with the OCS platform. Methods We retrospectively reviewed all OCS Lung recoveries performed by our recovery team, using packed red blood cells (pRBC) from May 2019 to January 2021. Initially, units were stored using passive refrigeration with the Performance cooler at a temperature range of 1 to 6 °C for 4 hours. Subsequently, thermal control technology with the ProMed cooler was utilized to maintain the same temperature range for 72 hours. Results Twenty-three recoveries were initiated with 63 pRBC. The Performance cooler was used for eight while the ProMed cooler for thirteen. 37.5% of pRBC transported with the Performance cooler was used within the validated time range, while 25.0% were used beyond the validated time range based on clinical judgment. In addition, 37.5% of pRBC transported with the Performance cooler were returned to the institution after canceled recoveries with an estimated loss of $1,800; the ProMed cooler had no wastage. Conclusions This study showed that using an advanced thermal packaging solution facilitates proper storage of pRBC and represents an advancement for extended donor lung preservation. The elimination of blood wastage in this initial study portends ongoing benefits for the limited blood supply and reduced cost.

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“…Studies investigating the cold chain protocols for vaccines within NZ focussed primarily on assessing the effectiveness of cold chain processes. Four studies found that current cold chain processes do not ensure the stability and potency of vaccines from manufacturer to when they are administered (Clancy, Karish, Roddy, Sicilia, & Bigham, 2017;Hazelton, Balcomb, Bowd, Hazelton-Parsons, & Liddle, 2002;Nursing Review, 2011;Turner, Laws, & Roberts, 2011). A document published by the Ministry of Health (2016) reviewing cold chain practices and management at a national level identified current cold chain protocols as a "significant issue and an area that needs urgent improvement in the future" (p.2).…”

Section: Cold Chain Protocol Implementationmentioning

confidence: 99%

“…Whilst not every study focused on the effectiveness of cold chain protocols, several identified the need for more comprehensive guidelines and planning surrounding cold chain. From a public health perspective, this would enable a decreased risk of errors, the prevention of cold chain breaches, excursions and failures and an increase in safety when storing, handling and administering vaccines (Chiodini, 2014;Clancy et al, 2017;Kosari et al, 2018;Ministry of Health, 2016;Turner et al, 2011). However, it is also important to note that some studies also investigated education programmes surrounding cold chain prractices yet did not identify significant changes following programme implementation (Datkuliak & Chichester, 2014;Hazelton et al, 2002;Thielmann, Viehmann, & Weltermann, 2015).…”

Section: Cold Chain Protocol Implementationmentioning

confidence: 99%

Cold Chain and its Importance

Churchman¹

2020

Scope (Health & Wellbeing)

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Olivia Churchman is a third-year nursing student currently undertaking a Bachelor of Nursing at Otago Polytechnic. Olivia began researching Cold Chain in New Zealand during her second year primary health clinical placement with Public Health Otago. By the completion of her clinical placement, Olivia had researched and developed the 6 C's of Cold Chain which was then distributed as a resource to Public Health Otago and the Immunisation Advisory Council. Olivia has continued to invest her interests and research into cold chain within New Zealand throughout her undergraduate education.

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Temperature-sensitive Medications in Interfacility Transport: The Ice Pack Myth

Cited by 10 publications

References 10 publications

Mean kinetic temperature evaluations through simulated temperature excursions and risk assessment with oral dosage usage for health programs

Mean kinetic temperature evaluations through simulated temperature excursions and risk assessment with oral dosage usage for health programs

Decreasing Blood Wastage During Ex Vivo Lung Perfusion Recovery Through Utilization of Thermal Control Technology

Cold Chain and its Importance

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