federal aviation administration regulation of schedule ii medications michael a. berry, m.d., m.s....
TRANSCRIPT
Federal AviationAdministrationRegulation of
Schedule IIMedications
Michael A. Berry, M.D., M.S.Manager, Medical Specialties DivisionOffice of Aerospace MedicineFederal Aviation AdministrationWashington, DC
Presented to:Federal Motor Carrier Safety Advisory CommitteeTuesday, Sept. 10, 2013
Regulation of Schedule II Medications2Federal Aviation
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Outline
• Medical Certification• Statistics• Methods• Medication Philosophy
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Medical Certificates - Types
• First Class– Required for airline transport pilots (ATP)
• Second Class– Required for commercial pilots
• Third Class– Required for private pilots
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AdministrationSeptember 10, 2013
Certification Statistics (FY 2012)• 380,158 Total Applications Received
203,545 First Class 72, 621 Second Class 103,992 Third Class
• 37,172 Special Issuances 16,920 First Class 6,778 Second Class 13,474 Third Class
• 3,405 Denials (0.9% of all applications)
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“Waivers” – Special Issuance• At the discretion of the Federal Air Surgeon
(FAS), an Authorization for Special Issuance of a medical certificate, valid for a specified period may be granted to an individual who does not meet the medical standards
• The airman medical certificate is issued in accordance with the special issuance section of Part 67 (14 CFR 67.401)
• An Authorization = a “waiver”
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“Waivers” – Special Issuance
• The person must show to the satisfaction of the FAS that the duties authorized by the class of medical certificate applied for can be performed without endangering public safety during the period of the Authorization
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“Waivers” – Special Issuance
• Certificates issued always have a time-limitation
• At the end of the validity period, the airman must once again show to the satisfaction of the FAS that the duties authorized can be performed without endangering public safety.
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Methods of Regulation
• Federal Regulations (CFRs)
• Pilot Education
• Aviation Medical Examiner Education
• Deterrence – DOT Testing
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AdministrationSeptember 10, 2013
Federal Regulations
• 49 U.S.C. 44703
Administrator’s authority to issue or deny medical certificates
• 14 CFR Part 67.407
Authority delegated to Federal Air Surgeon, Manager Aerospace Medical Certification Division, and Regional Flight Surgeons
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Federal Regulations: Medications
14 CFR Part 91.17 (a) (3)
"No person may act or attempt to act as a crewmember of a civil aircraft- While using any drug that affects the person's faculties in any way contrary to safety."
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Federal Regulations: Medications
14 CFR Part 61.53: Prohibition on operations during a medical deficiency
(1) Knows or has reason to know of any medical condition that would make the person unable to meet the requirements for the medical certificate necessary for the pilot operation; or
(2) is taking medication or receiving other treatment for a medical condition that results in the person being unable to meet the requirements necessary for the pilot operation.
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Federal Regulations: Medications
14 CFR Part 67.113, .213, .313:
General Medical Condition(1) Knows or has reason to know of any medical condition that would make the person unable to meet the requirements for the medical certificate necessary for the pilot operation; or
(2) is taking medication or receiving other treatment for a medical condition that results in the person being unable to meet the requirements necessary for the pilot operation.
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Pilot Education
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Pilot Safety Brochure
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• Safety Information for pilots• Chapter 8 – Medical Facts for Pilots
Section 1 - Fitness for Flight• Part c. - Medications
such as tranquilizers, sedatives, strong pain relievers, and cough-suppressant preparations, have primary effects that may impair judgment, memory, alertness, coordination, vision, and the ability to make calculations ….
Aeronautical Information Manual (AIM)
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i. PERSONAL CHECKLIST. I’m physically
and mentally safe to fly; not being impaired by: I’M SAFE
Illness
Medication
Stress
Alcohol
Fatigue
Emotion
Aeronautical Information Manual (AIM)
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AME Education
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Section on -
Pharmaceuticals (Therapeutic Medications)
Table of medication categories with Disposition – i.e.
–Antidepressants, –Sedatives, –Sleep aids, etc.
Guide for Aviation Medical Examiners
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Trade Name Generic Name Required minimum waiting time after last dose before resuming pilot or ATCS duties
Ambien zolpidem* 24 hoursAmbien CR zolpidem (extended
release)24 hours
Edluar zolpidem (dissolves under the tongue)
36 hours
Intermezzo zolpidem (for middle of the night awakening)
36 hours
Lunesta eszopiclone 30 hoursRestoril temazepam 72 hoursRozerem ramelteon 24 hoursSonata zaleplon 6 hoursZolpimist zolpidem (as oral spray) 48 hours
Guide for Aviation Medical Examiners
Sleep Aids
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Guide for Aviation Medical Examiners
Aeromedical Disposition for the following substances of Dependence or Abuse:
Alcohol Dependence/Abuse Marijuana
Amphetamines Narcotics
Anxiolytics Phencyclidine (PCP)
Cocaine Psychotropics
Hallucinogens Stimulants
Hypnotics Tranquilizers
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FAA Philosophy: Medications• Conservative approach to airmen medication use
• Grant medical certification for use of medications through Special Issuance ("waiver") process
• Underlying condition and the medication must have acceptable risk level
• Underlying condition often unacceptable for waiver rather than the treatment
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FAA Philosophy: Medications
• The FAA does not “approve” medications – the FDA does.
• Careful individualized evaluation of airmen with specific condition(s) using specific medication(s) to determine if the medication is aeromedically acceptable in that instance
• It is usually not the medication, but the medical condition that is the issue
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FAA Philosophy: Medications - Caveats• The individual must manifest no significant
adverse effects
• Cannot be “investigational" or “experimental”. It must be approved by the FDA for marketing and use in the United States
• The medication is not taken at greater than the maximum dose recommended by the manufacturer
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FAA Philosophy: Medications - Caveats
The medication, as reported by the usual authorities, must not produce frequent effects that could pose a safety risk in aviation. ["frequent" is considered more than 1% of the patients by FDA definition of adverse event rates]
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FAA Philosophy: Medications - Caveats
• The drug should not carry significant warning labels. Examples that would normally preclude certification:– FDA recommendation that a drug be used
only in hospitalized patients or in life-threatening conditions
– A “black box” warning for an aeromedically significant cardiovascular or neurologic adverse event
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AdministrationSeptember 10, 2013
FAA Philosophy: Medications - Caveats
• One-year of post-marketing experience with a new drug before consideration whether safely certificate airmen using the drug
• Applies for new drugs within an existing class and for drugs in a completely new class of drug
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FAA Philosophy: Medications - Caveats
• Use of a drug for conditions not included in the FDA-approved indications, i.e., “off-label” use, raises concern and circumstances evaluated carefully before any certification decision
• Certain drug combinations may be unacceptable because of side effects related only to the combination
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AdministrationSeptember 10, 2013
Medications - DQ
Medications generally disqualifying:
•The anti-Parkinson’s drugs
•Anti-seizure medications – used for any reason
•Sedative-hypnotics
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• Antihistamines, with the exception of some of the truly non-sedating antihistamines
• Centrally acting antihypertensives are unacceptable
• Active chemotherapy (and radiation therapy)
Medications - DQ
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Medications - DQ
• Tricyclic Antidepressants for ANY medical condition – UNACCEPTABLE
• Selective Serotonin Reuptake Inhibitors (SSRIs) for ANY medical condition – only under Special Issuance for 4 specific medications
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FAA Philosophy MedicationsAME must defer to the FAA for the following:
Anticoagulant Mood-ameliorating
Antiviral Motion Sickness
Anxiolytics Narcotic
Barbiturates Sedating Antihistaminic
Chemotherapeutic Agents Sedative
Experimental Steroid drugs
Hypoglycemic Tranquilizers
Investigational
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Deterrence
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0
5
10
15
20
25
30
35
40
45
50
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 FY2008*
FY 2009 FY 2010 FY 2011 FY 2012 FY 2013
18
26
31
3737
39
33
31
41
28
45
34
30
24
27
25
14
7
5
1110
9
22
16
7
13 14
9
13
7
11
14
9 9
Year
Part 67 (Pilot) Drug Positives and Alcohol ViolationsDrug Positives
Alcohol Violations
* Represents change from Calendar year to Fiscal year. 1997-2007 are based on Calendar year reported numbers.
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0
5
10
15
20
25
30
35
40
45
2118
11 1215
25
11
2319
138 9 8 7
1617
2517
16
16
16
21
15
17
1515 16
7
5 5 5 74 4 5 5 5
26 6 4
2
11
1
5 4
179
3
9 9
9
8
2 9
84
5
21
3
1
3 1
Part 67 (Pilot) Drug Positives and Alcohol Violations by Type of Test
"Other tests*"
Reasonable Cause/Suspicion tests
Random tests
Pre-employment tests
Drug Positives * Change from CY to FY Alcohol Violations * Change from CY to FY
NOTE: “Other Tests” include Post Accident, Follow Up, and Return-to-Duty tests.
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AdministrationSeptember 10, 2013
DOT Testing
• Alcohol (10% test rate)
– 50 K / 12 K Industry / Pilot tests per year– .097% /.044% Industry / Pilot positive rate
• Drugs (25% test rate)– 200 K / 48 K Industry / Pilot tests per year– .462 /.095% Industry / Pilot positive rate
Regulation of Schedule II Medications36Federal Aviation
AdministrationSeptember 10, 2013•July 29, 2010
QUESTIONS?