Regulation of Schedule II Medications

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Regulation of Schedule IIMedications
Michael A. Berry, M.D., M.S. Manager, Medical
Specialties Division Office of Aerospace
MedicineFederal Aviation Administration Washingto
n, DC
Presented to Federal Motor Carrier Safety
Advisory Committee Tuesday, Sept. 10, 2013
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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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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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Federal Regulations

• 49 U.S.C. 44703
• Administrators 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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Aeronautical Information Manual (AIM)

• 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 .

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Aeronautical Information Manual (AIM)

• i. PERSONAL CHECKLIST. Im physically
• and mentally safe to fly not being impaired
  by IM SAFE
• Illness
• Medication
• Stress
• Alcohol
• Fatigue
• Emotion

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AME Education
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Guide for Aviation Medical Examiners

• Section on -
• Pharmaceuticals (Therapeutic Medications)
• Table of medication categories with Disposition
  i.e.
• Antidepressants,
• Sedatives,
• Sleep aids, etc.

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Guide for Aviation Medical Examiners
Sleep Aids
Trade Name Generic Name Required minimum waiting time after last dose before resuming pilot or ATCS duties
Ambien zolpidem 24 hours
Ambien 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 hours
Restoril temazepam 72 hours
Rozerem ramelteon 24 hours
Sonata zaleplon 6 hours
Zolpimist zolpidem (as oral spray) 48 hours
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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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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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Medications - DQ

• Medications generally disqualifying
• The anti-Parkinsons drugs
• Anti-seizure medications used for any reason
• Sedative-hypnotics

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Medications - DQ

• Antihistamines, with the exception of some of the
  truly non-sedating antihistamines
• Centrally acting antihypertensives are
  unacceptable
• Active chemotherapy (and radiation therapy)

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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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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

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QUESTIONS?