Regulation of Schedule II Medications

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

2. Outline • Medical Certification • Statistics • Methods • Medication Philosophy

3. Medical Certificates - Types • First Class • Required for airline transport pilots (ATP) • Second Class • Required for commercial pilots • Third Class • Required for private pilots

4. 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)

5. “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”

6. “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

7. “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.

8. Methods of Regulation • Federal Regulations (CFRs) • Pilot Education • Aviation Medical Examiner Education • Deterrence – DOT Testing

9. 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

10. 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."

11. 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.

12. 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.

13. Pilot Education

14. Pilot Safety Brochure

15. 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….

16. Aeronautical Information Manual (AIM) i. PERSONAL CHECKLIST. I’m physically and mentally safe to fly; not being impaired by: I’M SAFE Illness Medication Stress Alcohol Fatigue Emotion

17. AME Education

18. Guide for Aviation Medical Examiners Section on - Pharmaceuticals (Therapeutic Medications) Table of medication categories with Disposition – i.e. • Antidepressants, • Sedatives, • Sleep aids, etc.

19. Guide for Aviation Medical Examiners Sleep Aids

20. Guide for Aviation Medical Examiners Aeromedical Disposition for the following substances of Dependence or Abuse:

21. 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

22. 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

23. 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

24. 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]

25. 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

26. 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

27. 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

28. Medications - DQ Medications generally disqualifying: • The anti-Parkinson’s drugs • Anti-seizure medications – used for any reason • Sedative-hypnotics

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

30. 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

31. FAA Philosophy MedicationsAME must defer to the FAA for the following:

32. Deterrence

35. 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

36. July 29, 2010 QUESTIONS?