GENERAL INFORMATION

NARRATIVE

[O] The Safety Board has investigated many accidents in all passenger transportation modes in which the use of a licit medication by a vehicle operator has been causal or contributory. As a result, the Safety Board has previously recommended that various agencies take certain actions to address issues pertaining to the use of medications. In this letter, the Board makes new recommendations to the DOT, modal administrations, and the U.S. Food and Drug Administration. [Recommendations] A-00-4. Establish, with assistance from experts on the effects of pharmacological agents on human performance and alertness, procedures or criteria by which pilots who medically require substances not on the U.S. Department of Transportation's list of approved medications may be allowed, when appropriate, to use those medications when flying. [Responses] FAA LTR DTD: 3/30/00 The Federal Aviation Administration (FAA) does not believe the Board's safety 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 duties 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 medications 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) every day. 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 interactions also presents an issue in any effort to establish a list of permissible 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. In the conduct of the airman medical certification program, the FAA reviews all reports of examinations conducted by AME's. Airmen who are found not qualified because of the use of a medication or an underlying medical condition may request consideration for special issuance of a medical certificate (waiver). 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. The FAA will continue its efforts to educate airmen regarding the dangers of medications in the aviation system and encourage airmen to seek counsel from their physicians and AME's regarding their medical conditions and treatment. The FAA will continue to seek the advice of outside medical specialists, when indicated, to determine the propriety of the use of specific medications by airmen. I consider the FAA's action to be completed on this safety recommendation, and I plan no further action. NTSB LTR DTD: 9/7/00 The FAA states that it does not believe that the Safety Board's recommendation to publish a list of medications "approved" for use by airmen is appropriate. The FAA further states that creating such a list would be a formidable and labor-intensive task of questionable benefit and that the list would require frequent updates. The FAA also details its airman medical certification program and the current procedures used to provide guidance on the appropriateness of medication use by individual airmen. The Safety Board is concerned that the FAA may have misunderstood the intent of this safety recommendation. This recommendation does not ask the FAA to create a list of approved medications for use by airmen. In Safety Recommendation I-00-2, which also resulted from this special study, the Board asked the Department 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 not on such a list. However, Safety Recommendation 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 Safety Recommendation 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 Safety Recommendation I-00-2, and recognizes that appropriate modal administration response to Safety Recommendation A-00-4 may need to await the DOT's response to Safety Recommendation 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, Safety Recommendation A-00-4 is classified "Open Unacceptable Response." FAA LTR DTD: 3/22/01 The Federal Aviation Administration (FAA) has reviewed its previous position in response to this safety recommendation and does not believe it is appropriate to publish a list of medications "approved" for use by airmen. The FAA has determined that developing a list of approved medications that may be safely used, and prohibiting the use of medications over twice the recommended dosing interval by safety-sensitive employees and employers, is not the correct approach. The medical certification process now in place at the FAA requires airmen to secure permission to fly while using reported medication. 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. The FAA fully understands the intent of this safety recommendation and has addressed this safety recommendation completely. I consider the FAA's action to be completed in response to this safety recommendation. NTSB LTR DTD: 1/25/05 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-00-04. 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." 4

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