Safety Recommendation A-00-005

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."

Letter Mail Controlled 1/18/2006 7:55:12 AM MC# 2060042 Marion C. Blakey, Administrator, FAA, 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: www.faa.gov/pilots/safety/pilotssafetybrochures. 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.cami.jccbi.gov/AAM-400A/fasmb.html. 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.

The FAA agrees that providing education programs and materials for pilots regarding the dangers 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-00-5 is classified "Open--Acceptable Response."

The FAA has educational programs and regulatory requirements in place that address these recommendations. 14 CFR 61.53, Prohibition of Operations During Medical Deficiencies, restricts 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.

The FAA has information on its Website and in a brochure regarding the use of over-the-counter medications and the dangers associated with the use of other prescription medicines. The FAA is currently developing a new brochure for completion by the end of calendar year 2004. It will update the information from the old brochure and expand it to include a section on prescription medications and flying. Once completed, the brochure will be electronically published on the Website. The brochure will also be available in paper form for distribution at AME seminars, safety seminars, "fly-in" meetings such as Oshkosh, and in AMEs' offices.

The FAA also plans to periodically update its Website to assure that the latest information is available to airmen and AMEs.

The FAA agrees that providing education programs and materials to airmen regarding the hazards of unapproved medications is beneficial. In addition to regulatory requirements regarding the prohibitions on flying while impaired, the FAA has ongoing educational programs that discuss this topic. Some of these ongoing programs are:

· Regional monthly aviation safety seminars, sponsored by the flight standards district offices, include topics on medical issues. In these seminars, 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.

· All AMEs are required to attend a basic seminar prior to being designated and to take refresher training at least once every three years. The refresher training can be accomplished through attendance at theme seminars that are provided by the FAA several time a year, or through a modular based program that the AMEs can complete on their computers at home. If the AME elects to use the computerized training, he or she must alternate that training by attendance at one of the theme seminars to satisfy the next training requirement. So, the AME must attend a theme seminar in person at least once every six years.

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 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, A-00-5 IS CLASSIFIED "OPEN--UNACCEPTABLE RESPONSE."

Letter Mail Controlled 04/04/2000 11:34:53 AM MC# 2000479 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 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 COULE 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 RECOMMENDATION.

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