Safety Recommendation A-00-004

The Safety Board notes that for many years the FAA has had an extensive and detailed system of aviation medical examiners (AMEs), who are physicians that evaluate medical conditions and medications for pilots and determine a pilot's fitness for flight duty. This system features extensive educational efforts for AMEs concerning medications and the availability of experts in the effects of medications on a pilot.

At the June 21, 2004, meeting, the FAA indicated that although it has always been and remains opposed to the creation by the Department of Transportation (DOT) of a list of approved medications, the FAA would rely on the existing AME system, if necessary, to take the actions in Safety Recommendation A-00-4. The Board urges the FAA to reconsider its opposition to the creation by DOT of a list of approved medications. Further, the Board urges the FAA to lend its support and considerable medical expertise related to a vehicle operator's fitness for duty to the creation of the DOT list.

At the June 21 meeting the FAA clarified its belief that the current AME system meets the intent of this recommendation. The current AME system was developed and operational before this recommendation was issued, and the FAA has not taken any additional actions in response. Therefore, based on the FAA's statement at the June 21 meeting that the current AME system has procedures that would be used to evaluate pilots who medically require substances not on a DOT list of approved medications to determine whether these pilots may be allowed to use those medications when flying, Safety Recommendation A-00-04 is classified "Closed--Reconsidered."

The NTSB recommended that the U.S. Department of Transportation's develop a list of approved medications, and that the FAA establish procedures or criteria by which pilots may be allowed to fly while using medications that are not on the approved list. The FAA believes that the following procedures fulfill the FAA's responsibilities with respect to the NTSB recommendations.

The FAA's approach to the use of medications by airmen, other than as provided for in 14 CFR Part 67, is to provide general and specific guidance to aviation medical examiners (AME) regarding those medications that present a safety risk during the performance of airman duties. AMEs are charged with the responsibility to inform airmen of the potential adverse effects of medications and to counsel airmen regarding their use. Airmen are encouraged to discuss medication issues with their private physicians, and with their AMEs. Medication information is also made available to airmen at safety seminars.

The medical certification process now in place at the FAA requires airmen to secure permission to fly while using reported medication. There are dangers inherent with the use of many medications and these dangers are complicated by the underlying medical condition for which the medication is taken. Because the FAA believes that all drugs taken for a medical reason have a potential to affect aviation piloting performance adversely, this process takes into account the drug and dosage level, the medical condition being treated, and the potential for adverse response to any given medication or combination of medications.

As a part of this process, safety aspects relating to the medication being used are considered by the FAA's medical staff, frequently in consultation with outside medical consultants. For medications newly approved by the FDA, consultation with the Federal Air Surgeon may be used to establish an agency position on the medication or class of medication. When necessary, further consultation with outside medical experts or organizations may establish whether such medications are appropriate for use while performing aviation duties. This process of review assures that the latest information available on medications will be available to an airman.

We believe that it may be productive to invite staff from the DOT and/or each of the modal agencies to discuss with our staff their concerns, priorities, and resource limitations before the Safety Board classifies the open recommendations to the DOT and other modal agencies. Based on our experience with the public meeting and the RSAC, it seems possible that such a meeting could result in some potentially acceptable alternate actions with regard to the current recommendations. We also recognize that each individual modal administration has a unique perspective and approach to the issue of medication use.

A meeting between staff could allow a complete discussion of the various distinctive concerns in each transportation mode. If desired, the FDA staff who participated in the public meeting could also be invited for their technical expertise. We are available to meet individually with the modal agencies or as a group.

Letter Mail Controlled 03/26/2001 7:57:42 PM MC# 2010257: The FAA has reviewed its previous position in response to this safety recommendation and believes that the ongoing educational programs outlined in the FAA's letter dated March 30, 2000, adequately address the hazards of medication and flying. These educational programs include distribution of medical publications to Aviation Medical Examiners (AME) to make available to airmen, providing material to AME's for presentation to airmen at flight safety meetings, providing FM support for training airmen at aviation events and activities.

The FAA fully understands the intent of this safety recommendation and has educational programs currently in place to address this safety recommendation completely. I consider the FAA's action to be completed in response to this safety recommendation.

THE SAFETY BOARD IS CONCERNED THAT THE FAA MAY HAVE MISUNDERSTOOD THE INTENT OF THIS RECOMMENDATION. THIS RECOMMENDATION DOES NOT ASK THE FAA TO CREATE A LIST OF APPROVED MEDICATIONS FOR USE BY AIRMEN. IN I-00-2, WHICH ALSO RESULTED FROM THIS SPECIAL STUDY, THE BOARD ASKED THE DEPT. OF TRANSPORTATION (DOT), WITH ASSISTANCE FROM EXPERTS ON THE EFFECTS OF PHARMACOLOGICAL AGENTS ON HUMAN PERFORMANCE AND ALERTNESS, TO DEVELOP FOR ALL MODES OF TRANSPORTATION "A LIST OF APPROVED MEDICATIONS AND/OR CLASSES OF MEDICATIONS THAT MAY BE USED SAFELY WHEN OPERATING A VEHICLE."

ALTHOUGH THE FAA, AS WELL AS OTHER DOT MODAL AGENCIES, MAY BE INVOLVED IN ANY DOT-SPONSORED CONSULTATIONS ASSOCIATED WITH THE CREATION OF THE LIST OF APPROVED MEDICATIONS, THE BOARD DOES NOT BELIEVE THIS WILL BE A LABOR-INTENSIVE OR FORMIDABLE TASK, FOR EITHER THE FAA OR THE DOT. A LIST SHOULD BE MAINTAINED ONLY OF THOSE DRUGS THAT DO NOT ADVERSELY AFFECT VEHICLE OPERATOR PERFORMANCE, AND THE MODAL ADMINISTRATIONS, INCLUDING THE FAA, SHOULD HAVE FLEXIBILITY IN PERMITTING THE USE, WHEN APPROPRIATE, OF MEDICATIONS NO ON SUCH A LIST.

HOWEVER, A-00-4 DOES NOT ASK THE FAA TO DEVELOP SUCH A LIST BUT RATHER ASKS THE FAA TO ESTABLISH PROCEDURES BY WHICH AIRMEN WHO NEEDED TO USE A MEDICATION NOT ON THE DOT LIST COULD REQUEST PERMISSION TO USE THEIR MEDICATION AND HAVE THEIR MEDICAL FITNESS FOR FLIGHT EVALUATED. AIRMEN WHO REQUIRE MEDICATIONS NOT ON THE LIST WOULD NOT BE PRECLUDED FROM BEING CERTIFIED AS FIT FOR FLIGHT, BUT WOULD BE REQUIRED TO FOLLOW FAA PROCEDURES, DEVELOPED IN RESPONSE TO A-00-4, TO SECURE PERMISSION TO FLY WHILE USING SUCH MEDICATIONS. THE SAFETY BOARD NOTES THAT THE PROCEDURES USED BY THE FAA TO MEDICALLY EVALUATE AIRMEN MAY FORM THE BASIS FOR A RESPONSE TO THIS RECOMMENDATION.

THE SAFETY BOARD ASKS THE FAA TO RECONSIDER ITS CONCLUSION THAT THIS RECOMMENDATION IS NOT APPROPRIATE. THE BOARD HAS NOT YET RECEIVED A REPLY FROM THE DOT REGARDING RECOMMENDATION I-00-2, AND RECOGNIZES THAT APPROPRIATE MODAL ADMINISTRATION RESPONSE TO A-00-4 MAY NEED TO AWAIT THE DOT'S RESPONSE TO I-00-2. PENDING THE ESTABLISHMENT OF PROCEDURES OR CRITERIA BY WHICH AIRMEN WHO MEDICALLY REQUIRE SUBSTANCES NOT ON THE DOT LIST OF APPROVED MEDICATIONS MAY BE ALLOWED, WHEN APPROPRIATE, TO USE THOSE MEDICATIONS WHEN FLYING, A-00-4 IS CLASSIFIED "OPEN--UNACCEPTABLE RESPONSE."

Letter Mail Controlled 04/04/2000 11:34:53 AM MC# 2000479 THE FAA DOES NOT BELIEVE THE BOARD'S RECOMMENDATION TO PUBLISH A LIST OF MEDICATIONS "APPROVED" FOR USE BY AIRMEN IS APPROPRIATE. THE FAA'S CURRENT APPROACH TO THE USE OF MEDICATIONS BY AIRMEN, OTHER THAN AS PROVIDED FOR IN 14 CFR PART 67, IS TO PROVIDE GENERAL AND SPECIFIC GUIDANCE TO AVIATION MEDICAL EXAMINERS (AME) REGARDING THOSE MEDICATIONS FOR WHICH THE USE DURING THE PERFORMANCE OF AIRMAN DUITES PRESENTS A SAFETY RISK. THE AME'S ARE CHARGED WITH THE RESPONSIBILITY TO INFORM AIRMEN OF THE POTENTIAL ADVERSE EFFECTS OF MEDICATIONS AND TO COUNSEL AIRMEN REGARDING THEIR USE.

THE FAA HAS PUBLISHED INFORMATION FOR AIRMEN RELATING TO THE USE OF SPECIFIC OVER-THE-COUNTER MEDICATIONS, AS WELL AS TO THE DANGERS ASSOCIATED WITH THE USE OF OTHER PRESCRIPTION MEDICINES. THE FAA CONDUCTS AND PARTICIPATES IN AVIATION SAFETY SEMINARS FOR AIRMEN WHERE MEDICAL ISSUES AND USE OF MEDICATIONS ARE FREQUENT TOPICS. AIRMEN ARE URGED TO DISCUSS THESE ISSUES WITH THEIR PHYSICIANS AND AME'S AND TO IDENTIFY THE ADVERSE EFFECTS THAT MAY OCCUR WITH THEIR PRESCRIBED MEDICATIONS. MOST IMPORTANTLY, AIRMEN ARE COUNSELED THAT IT MAY BE BETTER TO AVOID PERFORMING AVIATION DUTIES WHILE MEDICATIONS ARE REQUIRED.

CONSTRUCTING AND UPDATING A LIST OF PERMISSIBLE FOR USE BY AIRMEN WOULD PRESENT A FORMIDABLE AND LABOR-INTENSIVE TASK OF QUESTIONABLE BENEFIT. THOUSANDS OF PRESCRIPTION AND OVER-THE-COUNTER MEDICATIONS ARE CURRENTLY ON THE MARKET, AND NEW MEDICATIONS ARE APPROVED BY THE FOOD AND DRUG ADMINISTRATION (FDA) EVERYDAY. TO BE USEFUL, CONSTANT AND FREQUENT REVISION OF A LIST WOULD BE REQUIRED. RESOURCES THAT WOULD BE BETTER SPENT ENSURING THE MEDICAL QUALIFICATIONS OF AIRMEN WOULD HAVE TO BE DIVERTED TO MAINTENANCE OF THE LIST.

WHILE THE FAA RECOGNIZES THE DANGERS INHERENT WITH THE USE OF MANY MEDICATIONS, IT MUST ALSO BE CONCERNED WITH THE UNDERLYING MEDICAL CONDITION FOR WHICH THE MEDICATION IS TAKEN. MEDICATIONS THAT ARE OTHERWISE ACCEPTABLE FOR PILOTING AIRPLANES CANNOT BE CONSIDERED FOR USE BY AIRMEN UNTIL THE REASONS FOR WHICH THEY ARE PRESCRIBED ARE ASSESSED AND OBSERVATION HAS SHOWN NO EVIDENCE OF ADVERSE SIDE EFFECTS OR COMPLICATIONS. THE POTENTIAL FOR DRUG MEDICATIONS ALSO PRESENTS AN ISSUE IN ANY EFFORT TO ESTABLISH A LIST OF PERMISSABLE MEDICATIONS. WHILE CERTAIN MEDICATIONS USED ALONE MAY NOT BE PROBLEMATIC, IF USED IN COMBINATION WITH OTHER DRUGS, THEY COULD ENDANGER SAFETY.

IT IS ESSENTIAL THAT AIRMEN DISCUSS THEIR USE OF MEDICATIONS AND THE CONDITIONS FOR WHICH THEY ARE BEING USED WITH THEIR PHYSICIANS OR AME'S BEFORE FLYING, AS ENCOURAGED BY THE FAA. ANY LIST THAT ENCOURAGES AND FACILITATES THE AIRMAN'S SELF-DETERMINATION OF THE RISKS POSED BY VARIOUS MEDICAL CONDITIONS AND THEIR TREATMENT RAISES THE POTENTIAL FOR ERROR, FOR INAPPROPRIATE COMPLACENCY, AND, ULTIMATELY, FOR PILOT IMPAIRMENT. THE FAA'S APPROACH FACILITATES THE SAFE CONTINUATION OF PILOTING DUTIES WHEN INNOCUOUS MEDICATIONS ARE BEING USED, BUT WITHOUT CONFOUNDING THE PROCESS THROUGH MISLEADING PUBLICATIONS.

Letter Mail Controlled 02/14/2000 4:22:54 PM MC# 2000244