Temperature-Sensitivity Medication in Critical Care Transport

This report investigates the critical issue of temperature-sensitive medications in critical care transportation. It examines the impact of temperature fluctuations on medication stability and potency, highlighting the challenges of maintaining proper storage and handling in uncontrolled environments. The study analyzes three research papers, discussing current practices like the use of Packlt coolers and ice packs, and identifies limitations such as the lack of manufacturer data on medication degradation at varying temperatures. The report emphasizes the need for improved temperature control methods and detailed guidelines to prevent medication expiration and ensure patient safety. It also explores the implications of the findings, offering recommendations for training clinical staff and providing comprehensive manuals. The methodology includes a systematic review of literature using keywords related to temperature sensitivity, critical care, and medication, with the aim of informing informed storage norms for life-saving temperature-sensitive drugs.

Running head: TEMPERATURE- SENSITIVITY MEDICATION
Temperature- sensitivity medication in critical care transportation
Name of the Student
Name of the University
Author Note

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Abstract
Medication storage is regulated and temperature plays an important role in maintaining the
stability of the medications that are temperature sensitive. Potency of the medicines might get
lost because of the temperature as many hormones can be denatured due to the fluctuations in
temperatures. The temperature sensitive medications require extensive packaging and
temperature control. The aim of this study is to analyze the effect of the temperature in the
present day scenario as it aims to analyze the effect of the temperature on the temperature
sensitive medications. The paper describes three papers and draws some of recommendations
against the ways temperatures should be controlled.. The study also aims to throw a brief
light on the effective process that must be required to be undertaken in order to prevent the
expiration of medication during the process of transportation and thereby reducing the fatal
impact on the patients who are destined to receive that medicine.

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Introduction
Medication storage is stringently regulated via numerous reports which analyse the
impact of temperature on the process of medication stability (Hecq et al, 2015; Montes et al.,
2016). The phenomenon of medication stability is ascertained via numerous factors starting
from temperature, light, humidity, agitation and pH. It is the duty of the inpatient pharmacies
to work carefully in order maintains the requirements of the medication storage. The proper
storage of the temperature-sensitive medications in the less controlled setting of the critical
care transport cast significant challenges and hence should be taken under active
consideration both in the domain of patient care and fiscal perspective (Clancy et al., 2017).
Allowing medications to exceed the recommended temperature of the manufacturers’
thresholds could put the patient at a fatal risk for failed or unpredictable therapeutic response
towards medications or improper diagnostic test outcomes. The commonly used
transportation process for temperature sensitive medication in critical care include a cartridge
of 5 to 6 medicines (approximately) holding capacity and single point-of-care testing
equipments. This cartridge has a temperature limit of 2 to 25 degree C (Clancy et al., 2017).
However, if this temperature threshold is exceeded, the manufacturers of the medicines or
drugs have drug specific recommendations for proper handling and expirations of these
medications. However, if the medications are stored below the lower limit of storage, there
are no available data narrating the impact of medication stability from the manufacturers’ end
(Clancy et al., 2017).
According to the reports published by Helm et al. (2013), the environmental
temperature excursion under the emergency or critical care medical service settings, with
recorded temperature in Germany, America and Canada from -13 degree C to 50 degree C
account for nearly 30% more exposure time above the recommended temperature ranges (25

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degree C) and at least 20% of the time below the minimum storage limit of 0 degree C.
United states Pharmacopeia (USP) National Formulary prescribes the proper regulation of the
packaging, storage and distribution of medications (Brown, Krumperman & Fullagar ,2004).
The majority of the medications commonly employed by the emergency medical services
(EMS) are mainly intended for storage at “controlled room temperature”. The definition of
controlled room temperature as stated by USP is multifaceted ad extremely complex and thus
cannot be easily described as one of the simple range of acceptable temperatures or even as
an average temperature. According to Brown, Krumperman and Fullagar (2004), one of the
main uncontrolled aspect of external environment is temperature. Brown, Krumperman and
Fullagar (2004) stated that the evidence is clear that storage of EMS medication is not
consistent with the definition stated by USP in the domain of controlled room temperature.
Moreover, the impact of EMS over the process of medication storage, medication stability
and potency remains unclear.
Rationale
The following study is crucial in the present day scenario because it aims to analyse
the effect of temperature variance upon the temperature sensitive medication during the
process of transportation at the critical care settings. The study also aims to throw a brief light
on the effective process that must be required to be undertaken in order to prevent the
expiration of medication during the process of transportation and thereby reducing the fatal
impact on the patients who are destined to receive that medicine. The elucidation of the
results will help to design a detailed chart of the proceedings that must be helpful to protect
the efficacy of temperature sensitive medication for the critical care. The results will also
help to generate informed storage norms for life-saving temperature sensitive drugs like

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chemotherapeutic medication or intravenous antibiotics which crucial in critical care (Lv et
al., 2015).
Source: Clancy et al., (2017)
Source: Clancy et al., (2017)

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Methodology
The data for this paper was collected through the use of qualitative methods, based on
systematic review. In order to commence on the search of the literary articles, proper
identification of keywords were undertaken (Mcintosh-Scott et al., 2014). According to Polit
and Beck (2014), identification of keywords is crucial for proper capturing the proper concept
of the literature. The keywords, which were selected for the study is illustrated in the table
below:
Keywords Thesaurus terms Subject Headings
Temperature sensitivity Medicine temperature
sensitivity
Temperature sensitivity of
medication
Critical care Emergency care Critical care
Medications Drugs or capsule Medications
Electronic or online resources were used for the literary search of the articles based on
the keywords and the search limit was 15 years because it helped in the detailed analysis of
the data and most of the relevant papers were found within this range.
British Nursing Index Cochran Systematic Review Database
Google Scholar Internurse
Joanna Briggs Institute EBP database Library search of University articles
Medline
Table: Electronic resources used for the literature search
Source: Created by author

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The main inclusion criteria, which was selected for search of the literature, was
studies, which were published within the last 15 years and available in English. However, the
search of the literary articles was not limited by size of the trial or type of the literature. The
researcher included both qualitative and quantitative articles. The studies dealing with the
role of temperature sensitive medications and the handling of the temperature sensitive
medications by the nurses under the hospital settings were included in the search. In the
inclusion criteria, systematic reviews, surveys and meta-analysis were selected in order to
provide a comprehensive picture of temperature sensitive medication transportation in critical
care. According to Parahoo et al. (2014), inclusion and exclusion criteria are important to set
the boundary of the research while narrowing down the bibliographic resources available.
Results
The keyword search found 50 papers. These papers were again shortlisted based on their
research titles and 28 were found to be significant. These 28 papers were reviewed for short-
listing them on the e basis of abstract. Abstract analysis provided only 10 significant articles,
which came under the scope of this study. These 10 research papers were again reviewed
thoroughly and only 3 were found evident with scope, relevancy and nature of the research.
According to Clancy et al.,(2017) the current practices of the concerned hospital setting
involved the use of a Packlt cooler along with a commercially available ice pack. The pouch
is tamper resistant, tagged and non-insulated. The ice substitute pack is generally kept above
the Packlt cooler along with the tamper resistant pouch and the iSTAT cartridges kept below
the substitute pack. The paper had also provided a retrospective review of the various
transport durations and it was found that the current procedures of the transport of
medications are not that safe or efficient for storing or transporting the medications. It was
found that the medications exceeding the room temperature have experienced some loss of
potency. Although none of the manufactures published data about the retention of the

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medication potency could not validate the extent of the degree of degradation of the potency.
While experimenting on the temperature sensitivity of the Packlt cooler, it was found that the
deviation of the temperatures mandated about 2 . I℃ t strongly correlates to the starting
temperature for the cooler and the ice pack that is -12.4 . Under these conditions, the℃
medicines were observed to be under 2 for 50 minutes and three hours. Although no℃
recommendations for the manufacturers for dealing with medications at a temperature less
than 2 were provided. The results have found that proteinaceous compounds can easily℃
denature even if they are briefly exposed to temperatures below 0 . In context to this℃
experiment, the manufacturers could not provide any published data regarding the stability of
the hormones like prostaglandin and proctant alfa.
On the other hand, Chapa, (2014) describes about the different methods of
preservation as per the requirement of different medicines. This paper supports the findings
of the previously discussed paper of using supplementary ice packs for storing the
medications. According to the results shown by Chapa, (2014), it was found that the
medications like glyceryl nitrtate should be stored at temperature below 25 and should be℃
protected from light. The author has tried to find out whether application of any insulated
material can actually protect the heat sensitive materials. The novel feature of the intervention
is the humidity control device. The intervention was made for protecting the pharmaceutical
products from heat, light and moisture as well as mechanical damage. Corder & Mayer,
(2013) on the other hand have stated that the cold chain encompasses the storage and
transport facilities to ship temperature controlled medications. Here the author have discussed
that domestic refrigerators are certainly not suitable for the storage and the transport of the
high risk materials. Refrigerators are specially designed for the storage of medicinal products.
This paper has refuted the use of the dry ice and in case of the rubber Stoppard vials and it

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was also found that the low temperature causes shrinkage of the rubber vials. The paper also
emphasized on the use of special monitoring devices within the load.
Discussions and Implications of findings
Critical care transport has always been subjected to challenges for the delivery of
excellent and safe clinical care beyond the controlled hospital settings. Shafaat et al.,(2013)
have shown that if the temperature threshold is maintained (2 ℃- 8 ), then the strategies℃
becomes unfruitful for the trip durations more than three hour and the temperature sensitive
medications are considered adulterated if are used after the manufactured recommended
expiry dates. The manufacturers do not provide the exact of the degradation because the℃
stability of the medicine depends upon the stability and the potency of the active ingredient of
the medications. The limitation of the study is that the medication temperature is not
measured by directly opening the package due to the cost of the medications and the risk of
altering the temperature of the medicine by opening the package. Another limitation of this
study is that, there was no bioavailability or the potency studies on the medications as that
was beyond the scope of the studies. The paper emphasized on the fact that the current
refrigeration strategy is not suitable in storing or transporting the medications.
The implication of this study is that it gives an idea about the different temperature
controlled methods that are used for the transportation of the temperature controlled
medications and the relevance of the icepacks in iSTAT.
Dissemination plans
The manufacturers should provide the manuals in more details. The clinical staffs
should be provided with proper trainings regarding the storage and the transportation of the

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medications. Proper trainings shall be made given regarding the maintenance of the
equipment. Information handouts can be provided to the staffs.
Recommendations
There had been increasing number of temperature controlled medicines that require
controlled low temperature storage. According to Taylor, (2008), domestic refrigerators can
be used for the cold storage of small volumes of the medicinal products such as the eye drops.
a number of containers have been made for the transportation of the temperature sensitive
medicines. They are constructed out of a thermal insulating material and contain separate
baffles for separating the products from the temperature stabilizing materials like ice packs
(Taylor, 2008). All the refrigerator vehicles have to be well monitored with a continuous
recording devices or portable monitors placed within the load. The shipping companies
should regularly carry out their operations for confirming that they remain capable of
maintaining the quality of the product Clancy et al., 2012). Validated cool boxes from the
recognized medical supply should be used in conjunction with the minimum and the
maximum thermometers for ensuring the maintenance of the cold chain (Taylor, 2008).
Vaccines should be kept in the original packages and should be placed in cool boxes for
maintaining the potency of the vaccine (Kumru et al., 2014). All the cool boxes should be
transported out of direct sunlight and should be secured in the boot of the car (Luciano Jr, &
Luciano, 2012). There should be high and low temperature alarms and should be set within
suitable limits. The low temperature alert should trigger if the temperature drops below =1 C.
The alarms should be tested regularly. The large portable refrigerators should be regular
servicing. All the larger and the smaller units have to be cleaned regularly (Corder & Mayer,
2013).

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