Regulatory Brief -- NTSB issues safety recommendations on the use of medications

Regulatory Brief

NTSB issues safety recommendations on the use of medications

The issue:

On January 5, 2000, the National Transportation Safety Board (NTSB) voted on several safety recommendations to be given to the Department of Transportation (DOT), the Federal Aviation Administration (FAA) and the Food and Drug Administration (FDA) regarding the use of medications while operating motor vehicles. On January 13, 2000, the NTSB issued their safety recommendations, requesting that the DOT publish and maintain a list of medications "approved" for use while operating a vehicle.

The importance to our members:

The formulation of an "approved" medications list has potentially grim possibilities for all certificated airmen. FAAï¿½s dependence on such a list may lead to overly restrictive medical certification standards and may ultimately leave many airman "grounded". Further, FAA development and maintenance of an "approved" list will place a significant strain upon Aeromedicalï¿½s extremely limited resources. This is likely to result in a substantial increase in the backlog of medical applications currently plaguing the FAAï¿½s OKC offices.

Significant provisions:

The NTSBï¿½s recommendations include the following:

The establishment of an "approved" list of medications by the DOT;
The establishment of procedures or criteria by the FAA for pilots who medically require medication not on any "approved" medication list the DOT may develop;
FAAï¿½s development and periodic publishing of an easy-to-read source of information for pilots on the hazards of using specific medications when flying;
FAAï¿½s establishment and implementation of an educational program that targets pilots and ensures that all pilots are aware of the various sources of information regarding the hazards of certain medications when flying;
FDAï¿½s establishment of a system for clear, consistent and easily recognizable and prominently displayed warning label for all prescription and over-the counter (OTC) medications.

AOPA position:

AOPA opposes the establishment of an "approved" medication list. AOPA strongly believes that the FAA does not have the internal resources or the budget to manage an "approved" list of medication let alone establish procedures and criteria for pilots who must take medication not on the "approved" list. The lack of ability to maintain proper periodic oversight will have the undesirable effect of "grounding" many pilots because a particular or new medication had not yet been reviewed for approval or other disposition.

AOPA endorses the implementation of an educational program. In fact, AOPA has worked closely with the FAA in the past to develop educational materials highlighting the use of certain medications and their effects on pilot performance. AOPA will continue to support any educational efforts aimed at informing pilots of the hazards of using certain types of medications. In light of the NTSB recommendations, AOPA is pursuing new initiatives to help educate pilots about the use of medications while flying.

Most important, AOPA feels that clearer labeling and more prominent warning symbols will alleviate much of the confusion surrounding the use of certain medications while flying. AOPA supports the NTSBï¿½s product labeling recommendations and urges the FDA to implement clearer and more prominent warning.

Status:

On January 5, 2000 AOPA attended a meeting at which the NTSB voted to forward medication related Safety Recommendations to the DOT, FAA and FDA.
On January 13, 2000, NTSB released Safety Recommendations 00-1 through ï¿½6.
AOPA will respond to the NTSBï¿½s recommendations and keep the membership informed.