federal aviation administration regulation of schedule ii medications michael a. berry, m.d., m.s....

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

AdministrationSeptember 10, 2013

Outline

• Medical Certification• Statistics• Methods• Medication Philosophy

Medical Certificates - Types

• First Class– Required for airline transport pilots (ATP)

• Second Class– Required for commercial pilots

• Third Class– Required for private pilots

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)

“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”

“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

“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.

Methods of Regulation

• Federal Regulations (CFRs)

• Pilot Education

• Aviation Medical Examiner Education

• Deterrence – DOT Testing

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

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."

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.

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.

Pilot Education

Pilot Safety Brochure

• 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)

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)

AME Education

Section on -

Pharmaceuticals (Therapeutic Medications)

Table of medication categories with Disposition – i.e.

–Antidepressants, –Sedatives, –Sleep aids, etc.

Guide for Aviation Medical Examiners

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

Sleep Aids

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

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

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

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

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]

• 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

• 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

• 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

Medications - DQ

Medications generally disqualifying:

•The anti-Parkinson’s drugs

•Anti-seizure medications – used for any reason

•Sedative-hypnotics

• Antihistamines, with the exception of some of the truly non-sedating antihistamines

• Centrally acting antihypertensives are unacceptable

• Active chemotherapy (and radiation therapy)

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

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

Deterrence

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 FY2008*

FY 2009 FY 2010 FY 2011 FY 2012 FY 2013

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.

11 1215

138 9 8 7

1515 16

5 5 5 74 4 5 5 5

26 6 4

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.

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

AdministrationSeptember 10, 2013•July 29, 2010

QUESTIONS?

federal aviation administration regulation of schedule ii medications michael a. berry, m.d., m.s....

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