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

2. Regulation of Schedule II Medications 2 Federal Aviation Administration September 10, 2013 Outline Medical Certification Statistics Methods Medication Philosophy

3. Regulation of Schedule II Medications 3 Federal Aviation Administration September 10, 2013 Medical Certificates - Types First Class –Required for airline transport pilots (ATP) Second Class –Required for commercial pilots Third Class –Required for private pilots

4. Regulation of Schedule II Medications 4 Federal Aviation Administration September 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)

5. Regulation of Schedule II Medications 5 Federal Aviation Administration September 10, 2013 “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. Regulation of Schedule II Medications 6 Federal Aviation Administration September 10, 2013 “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. Regulation of Schedule II Medications 7 Federal Aviation Administration September 10, 2013 “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. Regulation of Schedule II Medications 8 Federal Aviation Administration September 10, 2013 Methods of Regulation Federal Regulations (CFRs) Pilot Education Aviation Medical Examiner Education Deterrence – DOT Testing

9. Regulation of Schedule II Medications 9 Federal Aviation Administration September 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

10. Regulation of Schedule II Medications 10 Federal Aviation Administration September 10, 2013 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. Regulation of Schedule II Medications 11 Federal Aviation Administration September 10, 2013 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. Regulation of Schedule II Medications 12 Federal Aviation Administration September 10, 2013 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. Regulation of Schedule II Medications 13 Federal Aviation Administration September 10, 2013 Pilot Education

14. Regulation of Schedule II Medications 14 Federal Aviation Administration September 10, 2013 Pilot Safety Brochure

15. Regulation of Schedule II Medications 15 Federal Aviation Administration September 10, 2013 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)

16. Regulation of Schedule II Medications 16 Federal Aviation Administration September 10, 2013 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)

17. Regulation of Schedule II Medications 17 Federal Aviation Administration September 10, 2013 AME Education

18. Regulation of Schedule II Medications 18 Federal Aviation Administration September 10, 2013 Section on - Pharmaceuticals (Therapeutic Medications) Table of medication categories with Disposition – i.e. –Antidepressants, –Sedatives, –Sleep aids, etc. Guide for Aviation Medical Examiners

19. Regulation of Schedule II Medications 19 Federal Aviation Administration September 10, 2013 Trade NameGeneric NameRequired minimum waiting time after last dose before resuming pilot or ATCS duties Ambienzolpidem*24 hours Ambien CRzolpidem (extended release) 24 hours Edluarzolpidem (dissolves under the tongue) 36 hours Intermezzozolpidem (for middle of the night awakening) 36 hours Lunestaeszopiclone30 hours Restoriltemazepam72 hours Rozeremramelteon24 hours Sonatazaleplon6 hours Zolpimistzolpidem (as oral spray)48 hours Guide for Aviation Medical Examiners Sleep Aids

20. Regulation of Schedule II Medications 20 Federal Aviation Administration September 10, 2013 Guide for Aviation Medical Examiners Aeromedical Disposition for the following substances of Dependence or Abuse: Alcohol Dependence/AbuseMarijuana AmphetaminesNarcotics AnxiolyticsPhencyclidine (PCP) CocainePsychotropics HallucinogensStimulants HypnoticsTranquilizers

21. Regulation of Schedule II Medications 21 Federal Aviation Administration September 10, 2013 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. Regulation of Schedule II Medications 22 Federal Aviation Administration September 10, 2013 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. Regulation of Schedule II Medications 23 Federal Aviation Administration September 10, 2013 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. Regulation of Schedule II Medications 24 Federal Aviation Administration September 10, 2013 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. Regulation of Schedule II Medications 25 Federal Aviation Administration September 10, 2013 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. Regulation of Schedule II Medications 26 Federal Aviation Administration September 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

27. Regulation of Schedule II Medications 27 Federal Aviation Administration September 10, 2013 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. Regulation of Schedule II Medications 28 Federal Aviation Administration September 10, 2013 Medications - DQ Medications generally disqualifying: The anti-Parkinson’s drugs Anti-seizure medications – used for any reason Sedative-hypnotics

29. Regulation of Schedule II Medications 29 Federal Aviation Administration September 10, 2013 Antihistamines, with the exception of some of the truly non-sedating antihistamines Centrally acting antihypertensives are unacceptable Active chemotherapy (and radiation therapy) Medications - DQ

30. Regulation of Schedule II Medications 30 Federal Aviation Administration September 10, 2013 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. Regulation of Schedule II Medications 31 Federal Aviation Administration September 10, 2013 FAA Philosophy Medications AME must defer to the FAA for the following: AnticoagulantMood-ameliorating AntiviralMotion Sickness AnxiolyticsNarcotic BarbituratesSedating Antihistaminic Chemotherapeutic AgentsSedative ExperimentalSteroid drugs HypoglycemicTranquilizers Investigational

32. Regulation of Schedule II Medications 32 Federal Aviation Administration September 10, 2013 Deterrence

33. Regulation of Schedule II Medications 33 Federal Aviation Administration September 10, 2013

34. Regulation of Schedule II Medications 34 Federal Aviation Administration September 10, 2013

35. Regulation of Schedule II Medications 35 Federal Aviation Administration September 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

36. Regulation of Schedule II Medications 36 Federal Aviation Administration September 10, 2013 July 29, 2010 QUESTIONS?