Temperature- Sensitivity Medication

Temperature- Sensitivity Medication

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Temperature- Sensitivity Medication

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Temperature- Sensitivity Medication

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Question:
Discuss about the Temperature- Sensitivity Medication In Critical Care Transportation.
 
 
Answer:

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 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 chemotherapeutic medication or intravenous antibiotics which crucial in critical care (Lv et al., 2015).
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
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 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 ?. It 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 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 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).
 
References
Brown, L. H., Krumperman, K., & Fullagar, C. J. (2004). Out-of-hospital medication storage temperatures:: a review of the literature and directions for the future. Prehospital Emergency Care, 8(2), 200-206.
Chapa, A. F. (2014). U.S. Patent No. 8,640,487. Washington, DC: U.S. Patent and Trademark Office.
Clancy, J., Karish, C., Roddy, M., Sicilia, J. J., & Bigham, M. T. (2017). Temperature-sensitive Medications in Interfacility Transport: The Ice Pack Myth. Air medical journal, 36(6), 302-306.
Clancy, J., Karish, C., Roddy, M., Sicilia, J. J., & Bigham, M. T. (2017). Temperature-sensitive Medications in Interfacility Transport: The Ice Pack Myth. Air medical journal, 36(6), 302-306.
Corder, J., & Mayer, W. T. (2013). U.S. Patent No. 8,424,335. Washington, DC: U.S. Patent and Trademark Office.
Hecq, J. D., Rolin, C., Godet, M., Gillet, P., Jamart, J., & Galanti, L. M. (2015). Long-term Stability of Esomeprazole in 5% Dextrose Infusion Polyolefin Bags at 5 degrees C+/-3 degrees C after Microwave Freeze-thaw Treatment. International journal of pharmaceutical compounding, 19(6), 521-524.
Helm, M., Castner, T. H., & Lampl, L. (2003). Environmental temperature stress on drugs in prehospital emergency medical service. Acta anaesthesiologica scandinavica, 47(4), 425-429.
Kumru, O. S., Joshi, S. B., Smith, D. E., Middaugh, C. R., Prusik, T., & Volkin, D. B. (2014). Vaccine instability in the cold chain: mechanisms, analysis and formulation strategies. Biologicals, 42(5), 237-259.
Luciano Jr, R. A., & Luciano, L. W. (2012). U.S. Patent No. 8,123,036. Washington, DC: U.S. Patent and Trademark Office.
Lv, R., Yang, P., He, F., Gai, S., Yang, G., Dai, Y., … & Lin, J. (2015). An imaging-guided platform for synergistic photodynamic/photothermal/chemo-therapy with pH/temperature-responsive drug release. Biomaterials, 63, 115-127.
McIntosh-Scott, A., Mason, T., Mason-Whitehead, E., & Coyle, D. (2013). Key concepts in nursing and healthcare research. Sage.
Meyer, C. E., DeVore, T. A., Kennison, A. E., Sieron, M. A., & Wynne, N. (2011). U.S. Patent No. 7,913,511. Washington, DC: U.S. Patent and Trademark Office.
Montes, J. A., Johnson, D., Jorgensen, J., McElmeel, M. L., Fulcher, L. C., & Kiel, J. W. (2016). Potency and Sterility of Fortified Tobramycin, Fortified Vancomycin, and Moxifloxacin at 4, 24, and 35° C for 14 Days. Cornea, 35(1), 122-126.
Parahoo, K. (2014). Nursing research: principles, process and issues. Palgrave Macmillan.
Polit, D. F., & Beck, C. T. (2014). Nursing research: Generating and assessing evidence for nursing practice. Lippincott Williams & Wilkins.
Shafaat, K., Hussain, A., Kumar, B., ul Hasan, R., Prabhat, P., & KumarYadav, V. (2013). An overview: storage of pharmaceutical products. world journal of pharmacy and pharmaceutical sciences, 2(5), 2499-2515.
Taylor, J. (2008). Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products. The pharmaceutical journal, 267(28), 128-131.

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