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-00-5. Develop, then periodically publish, an easy-to-understand source of information for pilots on the hazards of using specific medications when flying. [Responses] FAA LTR DTD: 3/30/00 The FAA has educational programs and regulatory requirements in place that address this safety concern. 14 CFR 61.53, Prohibition of Operations During Medical Deficiencies, proscribes airmen from aircrew duties while taking any medication or receiving any treatment that would render them unfit to meet the requirements of their medical certificates. This requirement also applies to glider and balloon pilots. Developing and updating an easy-to-understand source document for medications would present a formidable and labor-intensive task of questionable benefit. Resources that would have to be devoted to these tasks would be better spent on oversight of the airman medical certification system. As pointed out in response to Safety Recommendation A-00-4, there are thousands of prescription and over-the-counter medications currently on the market, and hundreds of new medications are approved by the FDA annually. Considering issues related to concerns for the underlying conditions for which medications are used, drug interactions, medication dosages, and the shear volume of medications that would have to be considered, it is unlikely that a source document that would be used or could be understood by airmen can be developed. Because new medications appear on the market daily, a source document would be outdated before it could be revised and published, resulting in the potential for the dissemination of outdated information. I believe that the FAA's procedures and regulations currently in place address this safety issue, and I plan no further action in response to this safety recommendation. NTSB LTR DTD: 9/7/00 The FAA indicates that it currently has educational programs and regulatory requirements in place that address this safety concern, noting that 14 Code of Federal Regulations (CFR) 61.53, "Prohibition of Operations During Medical Deficiencies," proscribes airmen from performing aircrew duties while taking any medication or receiving any treatment that would render them unfit to meet the requirements of their medical certificates. The FAA states that developing and updating an easy-to-understand source document for medications would present a formidable and labor-intensive task of questionable benefit, and that resources that would have to be devoted to those tasks would be better spent on the oversight of the airman medical certification system. The Safety Board notes that the FAA currently publishes a list of hazards to aviators using common over-the-counter medications, which has been designed by the FAA Civil Aeromedical Institute (CAMI) Aeromedical Education Division for distribution to pilots. No similar list exists for common prescription medications. In addition, the CAMI web site contains an extensive list of medications detected in pilots by the FAA's Toxicology and Accident Research Laboratory, including prescription, over-the-counter, and illegal recreational medications, along with occasional notes on the impact of these medications on an airman's ability to perform flight duties. The Board notes that these two current activities may form the basis for an acceptable response to this recommendation. The Board asks the FAA to reconsider its response to this recommendation. Pending the development and publication of an easy-to-understand source of information for pilots on the hazards of using specific medications when flying, Safety Recommendation A-00-5 is classified "Open Unacceptable Response." FAA LTR DTD: 3/22/01 The FAA has reviewed its previous position in response to this safety recommendation and continues to believe that developing and updating an easy-to-understand source document for medications would present a formidable and labor-intensive task of questionable benefit. Airmen have access to the Civil Aeromedical Institute's (CAMI) web site, which contains information on medications detected in pilots by the FAA's Toxicology and Accident Research Laboratory. The information available on the CAMI web site includes prescription medications detected in pilots, along with the notes on the impact of these medications on an airman's ability to perform flight duties. The FAA also publishes a list of common, over-the-counter medications and their hazards to aviators, which is distributed to pilots. I believe that the FAA's procedures and regulations currently in place address this safety issue completely, and I consider the FAA's action to be completed in response to this safety recommendation. NTSB LTR DTD: 1/25/05 The FAA agrees that providing education programs and materials for pilots regarding the danger associated with the use of over-the-counter (OTC) and prescription medications is useful. The FAA outlined a variety of educational programs and information sources currently available to both AMEs and pilots through seminars, bulletins, the Aeronautical Information Manual, and the FAA Web sites. The FAA reports that a new brochure is under development to update and expand information on OTC and prescription medications and their impact on flying. The brochure will be electronically published on the FAA's Web site, distributed to all AME offices, and made available at seminars and special events. The Safety Board requests that the FAA provide a draft copy of the brochure before it is published so that we may have an opportunity to provide comments. Pending completion of the updated brochure about the use of OTC and prescription medications, Safety Recommendation A-00-05 is classified "Open-Acceptable Response." The distribution plans outlined by the FAA for the updated brochure will make it available in a variety of venues to the pilots who are looking for the information. As discussed at the June 21, 2004, meeting, the Safety Board believes that every active pilot (that is, one with a current medical certificate) must be provided with a copy of the brochure to ensure that they are aware of this source of information. To address the intent of Safety Recommendation A-00-06, the FAA needs to develop a plan to distribute the information using a variety of methods such as direct mail, electronic mail, distribution by AMEs during recurrent medical examinations, or some other process. Pending development and implementation of an acceptable distribution plan, Safety Recommendation A-00-06 is classified "Open-Acceptable Response." FAA LTR DTD: 1/9/06 The Federal Aviation Administration has completed its efforts to address these safety recommendations. The following is a list of these items: * Issued a brochure and poster entitled "Medications and Flying." The brochure informs the reader of specific things to consider when making the decision to go/no go after taking over-the-counter drugs. The brochure also lists common side effects of frequently used medications. The brochure is available at the FAA's Web site at the following address: http://www.faa.gov/pilots/safety/pilotsafetybrochures. The brochure was mailed to all aviation medical examiners (AME) with instructions on how to obtain additional brochures. * Published an article in the Federal Air Surgeon's Medical Bulletin informing AMEs that the brochure and poster are available for download from the Civil Aerospace Medical Institute at: http://www.faa.gov/library/reports/medical/fasmb. * Published an editorial written by the Federal Air Surgeon in the Federal Air Surgeon's Medical Bulletin to stress the need for AMEs to communicate medication information to airmen. The FAA issued an FAA News release encouraging advocacy groups (i.e., the Airline Pilots Association, the Aircraft Owners and Pilots Association, and other aviation organizations) to disseminate information to their members regarding the brochure and its content. I have enclosed a copy of the brochure, the Federal Air Surgeon's Medical Bulletin, and the FAA News release for the Board's information. I believe that the FAA has satisfactorily responded to this safety recommendation, and I look forward to your response. NTSB LTR DTD: 6/23/06 The Safety Board reviewed the FAA's brochure titled "Medications and Flying," which (1) provides information for pilots about specific things to consider when making the decision to fly after taking drugs and (2) lists common side effects of frequently used medications. The brochure was distributed to all aviation medical examiners (AME) with instructions on how to obtain additional brochures and was placed on the FAA's Web site, where it is easily accessible. The brochure's creation and distribution meets the intent of Safety Recommendation A-00-5, which is classified "Closed-Acceptable Action." ?? ?? ?? ?? 4

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