Hostname: page-component-78c5997874-8bhkd Total loading time: 0 Render date: 2024-11-17T15:22:15.174Z Has data issue: false hasContentIssue false
  • English
  • Français

Effect of Extreme Temperature on Naloxone Nasal Spray Dispensing Device Performance

Published online by Cambridge University Press:  13 April 2020

Michael Estephan ,
Carly Loner  and
Nicole M. Acquisto Open the ORCID record for Nicole M. Acquisto [Opens in a new window]
Michael Estephan
Affiliation:
University of Rochester School of Medicine and Dentistry, Rochester, New YorkUSA
Carly Loner
Affiliation:
Department of Emergency Medicine, University of Rochester, Rochester, New YorkUSA
Nicole M. Acquisto*
Affiliation:
Department of Emergency Medicine, University of Rochester, Rochester, New YorkUSA Department of Pharmacy, University of Rochester Medical Center, Rochester, New YorkUSA
*
Correspondence: Nicole M. Acquisto, PharmD, Departments of Pharmacy and Emergency Medicine, University of Rochester Medical Center, 601 Elmwood Avenue, Box 638, Rochester, New York14642USA, E-mail: [email protected]
Get access Rights & Permissions [Opens in a new window]

Abstract

Introduction:

The opioid epidemic has led to the wide-spread distribution of naloxone to emergency personnel and to the general public. Recommended storage conditions based on prescribing information are between 15°C and 25°C (59°F and 77°F), with excursions permitted between 4°C and 40°C (39°F and 104°F). Actual storage likely varies widely with potential exposures to extreme temperatures outside of these ranges. These potentially prolonged extreme temperatures may alter the volume of naloxone dispensed from the nasal spray device, which could result in suboptimal efficacy.

Study Objective:

The aim of this study was to assess the naloxone volume deployed following nasal spray device storage at extreme temperatures over an extended period of time.

Methods:

Naloxone nasal spray devices were exposed to storage temperatures of −29°C (−20°F), 20°C (68°F), and 71°C (160°F) to simulate extreme temperatures and a control for 10 hours. First, the density was measured under each temperature condition. Following the density calculation part of the experiment, the mass of naloxone dispensed from each nasal spray device at each temperature was captured and used to calculate volume: calculated volume (microliter, µl) = spray mass (mg converted to g)/mean density (g/mL). Measurements and calculations are reported as means with standard deviation and standard error, and a one-way ANOVA was used to evaluate mean dispensed volume differences at different temperatures.

Results:

There was no difference in the mean volume deployed at −29°C (−20°F), 20°C (68°F), and 71°C (160°F), and measurements were 101.44µl (SD = 9.56; SE = 5.52), 99.01µl (SD = 6.31; SE = 3.64), and 108.28µl (SD = 2.04; SE = 1.18), respectively; P value = .289, F-statistic value = 1.535.

Conclusion:

The results of this study suggest that naloxone nasal spray devices will dispense the appropriate volume, even when stored at extreme temperatures outside of the manufacturer’s recommended range.

Keywords

administrationintranasalnaloxonenasal spraystemperature
Type
Original Research
Information
Prehospital and Disaster Medicine , Volume 35 , Issue 3 , June 2020 , pp. 272 - 275
Copyright
© World Association for Disaster and Emergency Medicine 2020

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Centers for Disease Control and Prevention. Wide-ranging Online Data for Epidemiologic Research (WONDER). https://wonder.cdc.gov/WelcomeT.html. Accessed October 5, 2019.Google Scholar
Hedegaard, H, Miniño, AM, Warner, M. Drug overdose deaths in the United States, 1999–2017. National Center for Health Statistics Data Brief, no 329. https://www.cdc.gov/nchs/data/databriefs/db329-h.pdf. Published 2018. Accessed October 5, 2019.Google Scholar
Rzasa Lynn, R, Galinkin, JL.Naloxone dosage for opioid reversal: current evidence and clinical implications. Ther Adv Drug Saf. 2017;9(1):63–88.CrossRefGoogle ScholarPubMed
World Health Organization. Community Management of Opioid Overdose. https://apps.who.int/iris/bitstream/handle/10665/137462/9789241548816_eng.pdf;jsessionid=AA5FFCB846B0C38400980F94BD4068CC?sequence=1. Published 2014. Accessed October 5, 2019.Google Scholar
McDonald, R, Strang, J.Are take-home naloxone programs effective? Systematic review utilizing application of the Bradford Hill criteria. Addiction. 2016;111(7):1177–1187.CrossRefGoogle Scholar
World Health Organization. Model List of Essential Medicines, 21st List. https://apps.who.int/iris/bitstream/handle/10665/325771/WHO-MVP-EMP-IAU-2019.06-eng.pdf?ua=1. Published 2019. Accessed October 5, 2019.Google Scholar
Adapt Pharma, Inc.; Radnor, Pennsylvania USA. Naloxone nasal spray 4mg/0.1mL. Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf. Published 2015. Accessed October 5, 2019.Google Scholar
Mylan Institutional LLC; Rockford, Illinois USA. Naloxone injection 0.4 mg/1mL. Prescribing Information. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=f0932877-1f3b-4d5e-82d2-dd6c53db4730&type=display. Published 2018. Accessed October 5, 2019.Google Scholar
Allegra, JR, Brennan, J, Lanier, V, Lavery, R, MacKenzie, B.Storage temperatures of out-of-hospital medications. Acad Emerg Med. 1999;6(11):1098–1103.CrossRefGoogle ScholarPubMed
Szucs, P, Allegra, JR, Fields, LA, et al.Storage temperatures of medications on an air medical helicopter. Air Med J. 2000;19(1):19–21.CrossRefGoogle ScholarPubMed
Brown, LH, Bailey, LC, Medwick, T, Okeke, CC, Krumperman, K, Tran, CD.Medication storage temperatures on US ambulances: a prospective multicenter observational study. Pharmoperial Forum. 2003;29(2):540–544.Google Scholar
Bureau of Justice Assistance National Training and Technical Assistance Center. Law Enforcement-Naloxone Toolkit 2019. https://bjatta.bja.ojp.gov/naloxone/how-should-naloxone-be-stored. Accessed October 5, 2019.Google Scholar
Vanos, JK, Middel, A, Poletti, MN, Selover, NJ.Evaluating the impact of solar radiation on pediatric heat balance within enclosed, hot vehicles. Temperature (Austin). 2018;5(3):276–292.CrossRefGoogle ScholarPubMed
Seymour, R.The glove compartment is an oven, not a medicine cabinet. JAMA. 1987;258(13):1734.CrossRefGoogle Scholar
Morin, CMD, Ivey, JW, Titosky, JTF, et al.Performance of pressurized metered-dose inhalers at extreme temperature conditions. J Pharm Sci. 2014;103(11):3553–3559.CrossRefGoogle ScholarPubMed
Wilson, AF, Mukai, DS, Ahdout, JJ.Effect of canister temperature on performance of metered-dose inhalers. Am Rev Respir Dis. 1991;143(5 Pt 1):1034–1037.CrossRefGoogle ScholarPubMed
McKeen, LW.The Effect of Temperature and Other Factors on Plastics and Elastomers. 3rd ed. Norwich, New York USA: William Andrew; 2014.Google Scholar
Aptar Radolfzell GmbH. Apparatus for controllably discharging flowable media. United States; Patent US5813570A, 1998.Google Scholar
Loner, C, Estephan, M, Davis, H, Cushman, JT, Acquisto, NM.Effect of fluctuating extreme temperatures on tranexamic acid. Prehosp Disaster Med. 2019;34(3):340–342.CrossRefGoogle ScholarPubMed