# February 22, 2013

U.S. Department of Transportation Docket Operations West Building Ground Floor, Room W12-140 1200 New Jersey Avenue, SE Washington, DC 20590

RE: Petition for Emergency Exemption regarding Emergency Medical Equipment; 14 CFR §

121.803

Dear Sir or Madam:

In accordance with the provisions of Title 14, Code of Federal Regulations §§ 11.63, 11.81, and 11.87, Spirit Airlines, Inc. petitions for emergency expedited approval of a limited exemption from 14 CFR § 121.803(c)(3), which requires airplanes with seating capacity of more than nine passengers to carry an Emergency Medical Kit (EMK) with contents as specified in Appendix A to Part 121. Specifically, Spirit requests a temporar y exemption from the requirements of 14 CFR § 121.803(c)(d) Part 121, Appendix A to the extent necessary to relieve it from the requirement to carry one single do se ampule of Dextrose, 50%/50 cc injectable in required onboard EMKs. Due to a manufacturing shortfall, Spirit’s EMK provider is currently unable to restock this medication, creating the potential that Spirit will be unable to comply with the requirements of Appendix A. Due to the expected temporary nature of the shortage, Spirit

req uests an exemption from this requirement through July 31, 2013 or until the shortage is
resolved.

Current Shortage of Dextrose:

On February 21, 2013, Spirit was advised by its medical kit provider MedAire that as of February 20, 2013 it has depleted its stock of dextrose, and due to manufacturing shortages, does

no t expect to be able to provide dextrose for inclusion in EMKs until at least the end of June 2013. (See February 20, 2013 MedAire notice attached).

Dextrose 50% (also known as d-50) is an injectable solution of sugar in water at a 50% concentration, which is used to restore blood glucose levels in acute severe hypoglycemia or insulin
shock. It has been a required component of EMKs since 1986. Appendix A calls for it to be stocke d in injectable single dose ampules. There are currently two companies producing this product in the United States, Amphastar (IMS) and Hospira, Inc. Both report shortages of the product due to manufacturing delays and increased demand and currently have the product on back order. 1 

# Hospira expects to have the product available this month, and Amphastar is intermittently releasing the

1 

## FDA, Current Drug Shortages, http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm#dextrose (enclosed)

## Petition for Exemption

February 22, 2013

2 

# product as it becomes available. However, as explained by MedAire, priority for filling back orders will be given to first line medical facilities and emergency response units. MedAire does not expect the drug to be available for inclusion in EMKs until at least the end of June 2013.

Ordinarily, Spirit maintains a certain number of extra EMKs to replace those that are opened during a medical emergency. The used EMKs are then sent back to MedAire for refurbishment. In addition, all EMKs are restocked periodically to replace expired products. Beginning today, MedAire plans to return kits without restocking dextrose 50% if this drug has not expired or been used. However, if the dextrose in the EMK has expired or been used, MedAire will not replace this product and the kit cannot be returned to use under the requirements of Appendix A.



# Applicable Regulation and Relief Sought:

14 C.F.R. § 121.803(c)(3) requires aircraft with more than nine passenger seats to be equipped with EMKs, and Part 121, Appendix A specifies that the EMK contains, among other items, dextrose 50%. Although Appendix A states that the EMK include these for mulations “or equivalent,” in the case of dextrose 50% there is no true equivalent.



# Spirit requests a temporary, one-year exemption from the requirements of 14 CFR § 121.803(c)(d) Part 121, Appendix A to the extent necessary to relieve it from the requirement to carry one single dose ampule of dextrose, 50%/50 cc injectable in required on-board EMKs through July 31, 2013 or until this shortage has been alleviated 

# . EMKs lacking dextrose would be clearly labeled and flight attendants informed of this change in the EMK contents as part of preflight briefing.

Alternatively, the FAA could grant Spirit approval to use glucagon 1 mg as a substitute for dextrose, subject to availability, through July 31, 2013 or until this shortage has been alleviated. Although not an identical product, glucagon 1 mg will achieve similar results to dextrose in the majority of the population by raising the blood glucose levels in passengers with severe hypoglycemia. Again, the EMKs containing this substitution would be clearly labeled and flight attendants informed of this change in the EMK contents as part of pre-flight briefing.

Due to the current unavailability of dextrose and the unpredictability of when Spirit’s curren t supply of the product will be exhausted, 

# pursuant to 14 CFR § 11.87, Spirit requests that the FAA waive publication and expeditiously provide the relief requested.

Granting this Exemption would be in the Public Interest:

Absent this relief, Spirit would be unable to fully comply with FAR 121.803 should dextrose need to be restocked in an EMK, creating the possibility that aircraft would have to be taken out of service. Grounding otherwise airworthy aircraft for this reason alone would disrupt air service and is not in the interest of the traveling public. Granting this exemption would serve the public interest by help ing to ensure that Spirit’s operations continue uninterrupted.

Further, as this shortage is affecting all types of medical service providers, it would be in the public interest to prioritize the needs of first line medical facilities and emergency response providers by preventing airlines from needing to compete with these entities for the limited stock of dextrose.

## Petition for Exemption

February 22, 2013

3 

# Granting this Exemption would not adversely affect safety:

While dextrose may be important in cases of severe hypoglycemia, such cases are exceedingly rare. A recent review of 2012 data by MedAire, a major provider of EMKs and in-flight medical advisory services, suggests that only .02% of in-flight cases were serious enough to call for the use of dextrose or glucagon in order to manage the medical emergency. Accordingly, the risk of the lack of dextrose resulting in a life-threatening situation during the limited period when this exemption would apply is very low. Further, should the FAA allow the substitution of glucagon
that risk decreases even more.

Exercise of this Exemption outside the United States:

Spirit also requests that it be allowed to exercise this privilege outside of the United States. The International Civil Aviation Organization recommends that dextrose be included in EMKs but does not specifically require it. 2 

# Accordingly, Spirit would not violate ICAO requirements if

dextrose was not present in an EMK.

Summary of Petition:

Petitioner: Spirit Airline, Inc.

Affected Regulations: 14 CFR 121.803(c)(3) and 14 CFR part 121, Appendix A - First Aid Kits and Emergency Medical Kits.

Summary of Relief Sought: The relief would temporarily exempt Spirit Airlines, Inc. from having to carry dextrose in EMKs due to a manufacturing shortage of the drug

Granting this exemption is in the public interest as it avoids potential, unpredictable

disru ptions in scheduled air transport service.

For the foregoing reasons, Spirit respectfully request an expedited exemption from the requirements of 14 C.F.R. § 121.803(c)(3) and Appendix A to Part 121 pertaining to the provision of dextrose in the EMK through July 2013 or until this shortage is resolved.

2 

## ICAO, International Standards and Recommended Practices, Annex 6 to the Convention on International Civil Aviation (Ninth Edition, July 2010), Part I, para. 6.2.2

## Petition for Exemption

February 22, 2013

4 

# Respectfully submitted February 22, 2013 by:

Joanne W. Young
David M. Kirstein Kirstein & Young PLLC
1750 K Street N.W.
Suite 200 Washington, D.C. 20006 (202) 331-3348 (telephone) (202) 331-3933 (facsimile)

Counsel for SPIRIT AIRLINES, INC.

CC (by email):

Mr. John Allen
Federal Aviation Administration Director, Flight Standards Service, AFS-1 800 Independence Ave., SW Washington, DC 20591

Mr. John Duncan
Federal Aviation Administration Deputy Director for Policy, Flight Standards, AFS-2P 800 Independence Ave., SW Washington, DC 20591

Mr. Les Smith
Federal Aviation Administration Flight Standards Service Air Transport Division, AFS-200 800 Independence Avenue, SW Washington, DC 20591

Mr . Steve Douglas
Federal Aviation Administration Flight Standards Service Aircraft Maintenance Division, AFS-300 470 L’Enfant Plaza, SW Washington, DC 20024

Enclosure/

# February 21, 2013

Dear Sir or Madame,

MedAire produces FAR-compliant medical kits for your airline subject to Part 121 requirements.

Recent pharmaceutical manufacturing c hanges have reduced t he availability of
Dextrose. Dextrose 50%, inj. 50 mL is an FAA-required component for onboard medical kits according to 14 CFR Part 121.803, Appendix A.

As of February 20, MedAire has depleted its supply of Dextrose. Should your carrier request new medical kits, or r equest refurbishment of existing medical kits with expired or missing Dextrose, MedA ire will be unable to prov ide FAR-compliant kits.

Beginning today, we are coordinating with your carrier to re-furbish only those used and expired medical kits which st ill contain Dextrose that has not yet expired. In these cases, the kits will be usable fo r only the period of time in wh ich the existing Dextrose is usable—dating that varies from 1 to 11 mont hs. For kits containing expired Dextrose,
we are not able to refurb ish them at this time.

The manufacturers have indicated that th ey will begin distributing the drug again sometime in February and antici pate that availability will meet demand sometime in Q2 2013. This timeline is dynamic, however, and once distribution begins again, distribution
is at the discretion of the manufacturer. T he typical distribution will be to first line medical facilities and emergency response units and finally to suppliers such as MedAire. To that end, we ant icipate that this shortage ma y extend to the end of Q2 2013 or longer.

For additional information about the Dextrose production shortage, please refer to the following links: http://www.fda.gov/Drugs/DrugSafet y/DrugShortages/ucm 314739.htm#dextrose http://www.ashp.org/DrugShortage s/Current/bulletin.aspx?id=988

# Based on a formal review by MedAire’s Medi cal Equipment Review Board, there are two acceptable equivalent medications for t he Dextrose 50%/50 cc (single dose ampule or equivalent) requirement:

• Glucagon 1mg-- Although not an identical product, gl ucagon 1 mg will achieve similar results in the majority of the popul ation by raising the blood glucose levels in passengers with severe hypoglycemia.

• Dextrose 25% [2 doses]. Note: There is also currently a shortage of Dextrose
25%.

MedAire supports airlines with in-flight medical advisory services, assisting with approximately 25,000 events each year. A recent review of data from 2012 suggests that .02% of in-flight case s were serious enough to call for use of Glucagon [which some airlines stock] or Dextrose-- the nec essary intervention to manage the medical emergency. It should be noted that these dr ugs are indicated in cases of severe hypoglycemia which although uncomm on could be life-threatening.

Please let us know if we can pr ovide any additional information.

Sincerely,

Heidi MacFarlane

Vice President, Strategic Development MedAire, an International SOS company Paulo Alves, MD, MSc, FAsMA

Vice President, Aviation and Maritime
Health MedAire, an International SOS company

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