U.S. FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

Transportation Safety

and

Potentially Sedating or Impairing Medications

National Transportation Safety Board Headquarters

429 L'Enfant Plaza

Washington, D.C.

Thursday, November 15, 2001

8:00 a.m.

Acting Principal Deputy Commissioner

Food and Drug Administration

Vice Chairman

National Transportation Safety Board

Co-Chairs

STEVEN GALSON, M.D., M.P.H.

Deputy Director

Center for Drug Evaluation and Research

Food and Drug Administration

DR. VERNON ELLINGSTAD

Director

Office of Research & Engineering

National Transportation Safety Board

On behalf of the Food and Drug

Administration:

DR. ROBERT TEMPLE

Director

Office of Medical Policy & Office of Drug

Evaluation I

On behalf of the Food and Drug

Administration:

DR. ROBERT MEYER

Director

Division of Pulmonary and Allergy Drug

Products

DR. CHARLES GANLEY

Director

Division of Over-the-Counter Drug Products

DR. RUSSELL KATZ

Director

Division of Neuropharmacological Drug

Products

DR. THOMAS LAUGHREN

Supervisory Medical Officer

Division of Neuropharmacological Drug

Products

DR. PAUL ANDREASON

Medical Officer

Division of Neuropharmacological Drug

Products

On behalf of the National Transportation

Safety Board:

DR. MITCHELL GARBER

Medical Officer

Office of Research & Engineering

DR. MARGARET SWEENEY

Transportation Research Analyst

Safety Studies Division

Office of Research & Engineering

MR. PETE KOTOWSKI

Motor Carrier Specialist

Office of Highway Safety

MR. RAFAEL MARSHALL

Project Manager

Office of Highway Safety

Invited Parties

Advocacy Groups

KAREN TARNEY

Citizens Against Drug Impaired Drivers

Industry

TODD SPENCER

Owner-Operator Independent Drivers

CORRINE RUSSELL

Consumer Healthcare Products Association

WILLIAM MAHORNEY

American Bus Association

NORM LITTLER

United Motor Coach Association

TOM FAULKNER

Air Transport Association

BILL BRADLEY

Consumer Healthcare Products Association

Operator Unions

KAREN HEAD

Legislative Council

CAPTAIN RANDY POPIEL

Allied Pilots Association

Government

ROBERT M. CLARKE

DR. FREDERICK TILTON

Professional

RICHARD GELULA

National Sleep Foundation

DARREL DROBNICH

National Sleep Foundation

A G E N D A

AGENDA ITEM: PAGE:

Administrative Announcements and Opening 328

Remarks

Witness Panel V - Education 329

Kenneth Edgell

Office of the Secretary of Transportation

Office of Drug and Alcohol Policy and

Compliance

Washington, D.C.

Natalie Hartenbaum, M.D., M.P.H.

Occumedix

Maple Glen, PA

Allen Parmet, M.D., M.P.H.

Midwest Occupational Medicine

Kansas City, Missouri

Questions from Technical Panel/Parties 346

and Discussion

Witness Panel VI - International 428

Jenny Bergin

Pharmacist Consultant

National Secretariat of the Pharmacy Guild

Australia

Asbjorg S. Christophersen, Ph.D.

Associate Director

National Institute of Forensic Toxicology

Norway

Dr. Johann J. de Gier

Ultrecht Institute for Pharmaceutical Science

The Netherlands

Questions from Technical Panel and Discussion 459

A G E N D A

AGENDA ITEM: PAGE:

Afternoon Session

Witness Panel VII - Warning Labels 495

Ruth Day, Ph.D.

Duke University

Durham, North Carolina

R. William Soller

Senior Vice President and Director,

Science and Technology

Consumer Healthcare Products Association

Washington, D.C.

Bert Spilker, Ph.D., M.D.

Pharmaceutical Research and Manufacturers

of America

Washington, D.C.

Michael Wogalter, Ph.D.

North Carolina State University

Raleigh, North Carolina

Questions from Technical Panel/Parties 521

and Discussion

Adjournment

P R O C E E D I N G S

8:06 a.m.

Administrative Announcements and Opening Remarks DR. ELLINGSTAD: Welcome back. We're off schedule already. I'm sure we'll make up for that.We'll have three panels today. A couple of announcements first.

Again, as -- as yesterday, questions from the audience may be given to one of the staff members who's -- who have the index cards, and if you get that -- give -- give those questions to them we will ask that at the conclusion of the round of -- of questioning.

We also will -- have scheduled a 1:00 audience discussion session as we had yesterday for those who have -- have preregistered to make some remarks. At the moment no one has -- has registered for that, and essentially, anybody that wishes to do so should do that by the time of the first break. What is likely to happen is that we will move up the start of our afternoon panel to 1:00. So, we -- we possibly will -- will be able to exceed the schedule that we have printed up here.

Are there -- you have, Steve?

DR. GALSON: Just very quickly. The reason this meeting is running so smoothly is because of a lot of hard work of -- of -- and planning and also running the mechanics of the room, and I just want to acknowledge the hard work and assistance of those folks. From FDA, Lee Lemley and Anne Henig, who are standing in the back. From NTSB, Carolyn Dargan and Mary Jones. I'm not quite sure where they are but they're around. And then, helping us in the room is Antione Downs and Will Scholochenko. Thank you very much. Doing a great job.

DR. ELLINGSTAD: Thank you. We'll begin this morning with our Education Panel. And our first panelist is Dr. Natalie Hartenbaum from Occumedix in Maple Glen, Pennsylvania.

Dr. Hartenbaum?

Witness Panel V - Education

DR. HARTENBAUM: Thank you for inviting me -- that better? Okay. Sorry about that. Didn't sound like it was vibrating yet.

While I'm primarily going to address educating operators, I think it's equally important to look that we have to also educate healthcare providers, and this is not just the medical examiners that work for the companies but also the treating providers. While companies are aware that they do have a requirement to educate their operators, they do so in many different ways. I've spoken with several of my colleagues in occupational medicine, both in the corporate and private practice setting, to get a sense of what the different organizations are doing. I've also practiced in private practice and served as medical director of a Class 1 railroad, so I'm going to primarily address commercial highway driving and rail.

Many of the companies will advise their operators to talk to their treating providers and read labels, which is a nice start. Some of them will also tell them to have their providers or have the employees themselves talk to the companies' medical professionals to discuss the side effects of medications. This may work well in some cases but it doesn't work very well when we're dealing with over-the-counter medications where there are no medical professionals involved in the prescribing.

Some of the drivers may actually go ahead, take the medication insert, read it, pulling up their reading glasses first if they need to, and look for the great words that say, "Use caution when driving motor vehicle or operating machinery." These operators will indeed use caution. They will be careful. They will work more slowly. But they are still impaired. Evidence has shown that they cannot always adequately assess the degree of impairment these medications may cause.

Some companies do require that individuals in safety-sensitive operations provide information from their healthcare professional that the medication they're using is safe, medication they're using will not impair their operations. And what they will do is some companies will also ask that the medical examiners for that company interview and instruct.

For the rail industry, the only individuals required to have regular contact with health professionals are locomotive engineers. This occurs only once every three years and they're only required to address vision, hearing, and color vision.

For highway, the new medical examination reporting form requires the examiner to discuss with the driver the potential hazards of medications, both prescription and over-the-counter. But here again, the only thing the examiner can do is advise them to talk to their treating provider and read warning labels.

With very few exceptions commercial driving, the only -- there are very few specific limitations on medications. They are not supposed to be using any medication which is impairing or may be habit-forming. However, if they have a health professional who is prescribing a medication and states they are not impaired, they can continue to work in commercial operations.

Many examiners and many companies attempt to get this information from the treating provider and may give questionnaires similar to the one in the binder containing questions such as these. The treating professional looks at the patient -- their patient they want to keep happy and says, "Are you having side effects?" What does the driver or operator say? "No, I'm not." He knows if he answers he's having problems he'll be pulled from service. The healthcare professional says, "Okay. Fine. You're safe to drive," signs off the form, it goes back to the company. The company's medical examiner has no option but tries to challenge or question this medical professional. The response that they often get is, "I know this patient longer than you have and he's better now than he's been for the past five years not on the medication," not understanding the full implications of this partially incomplete assessment and the impairment that this medication may cause.

There are some guidance available for commercial driver medical examiners. In conference reports prepared by -- they were conferences sponsored by the Federal Highway Administration. These, however, predated the ADA. So, even though it contains recommendations on both classes of medications and specific medications, examiners for companies who try to prohibit this are challenged because they need to do an individualized assessment on each driver.

Some of the companies will have information such as the FDA does have a nice pamphlet called "Over-the-Counter Medications and Flying," maybe you shouldn't. There are also information prepared by -- pharmaceutical companies who try to reach out to the healthcare providers and explain to them the importance of impairing medication while at work, not just while driving.

The FAA has a bulletin available and the FTA also has a newsletter available that has in the past covered medication's potential impairment. The FRA and the FMCSA does not at this point have a vehicle for this. Labeling is one start but it's just as important to make certain that the health professionals, the healthcare professionals, understand the importance of a complete assessment and how impairing and how dangerous some of these medications can be.

DR. ELLINGSTAD: Thank you. Dr. Garber has reminded me that I've neglected to make the obligatory fire safety announcement. And in the event of an emergency such as a fire, the building fire alarm will activate and a voice message will instruct persons to vacate the building. If that happens, you should proceed to the nearest exit. There are emergency exits up in the front here on either side of the platform and at the back of the room. Sorry for having neglected that, intruding into the program.

Our next panelist is Dr. Allen Parmet, Midwest Occupational Medicine, Kansas City, Missouri.

Dr. Parmet?

DR. PARMET: Thank you for inviting me.

My background is about 25 years in the military medicine and about 10 years in private practice. The last six years I was medical director for an American Airline company, which was a not-for-profit company. It wasn't on purpose. Just kind of worked out that way. But back in private practice now.

I am a pilot and before I started all this I was actually an air traffic controller for the military, so I've been in this business a long time.

Our point of view from aviation is very similar. I'll have to preface my remarks by saying I totally agree with what Dr. Hartenbaum has said and want to build a few things with regard to aviation.

Our pilots and air traffic controllers are regulated and we have the FAA to rely on and often to blame. When we need somebody to blame, we're very happy to have them there because it gives us the opportunity to say, "You can't take any medications without approval." That's a blanket statement. Nothing. And at least in my company, our rule was that any medication taken must be reported to the company medical director and I personally reviewed all the reports that were submitted and had to approve somebody to return to work. I won't say that everybody actually did that, but that was the rule and it was enforced if somebody was found not to be compliant with it.

But across the board, the only regulations that really apply are to the pilots and air traffic controllers. We have other safety-sensitive personnel as well, including our mechanics, our flight attendants, and security people. And we certainly don't need a mechanic who is sedated and forgets to screw the bolts that hold the tail plane on. We don't need a security person who falls asleep and allows a few pieces of cutlery to go through the X-ray machine. So, our -- our needs are quite broad here.

And we can't use accidents as the end point because those events are so rare as to not give us a good statistical evaluation. We have to be able to evaluate cognitive impairment by a means less than that.

We also have to evaluate it over a very broad screen. We of course don't -- in -- general commercial aviation don't -- don't have any 60-year-old -- 61-year-old pilots, but we do know that -- that aging affects the results of some of these medications, so we have to look at that as well.

The other thing is the environment we operate in is not quite the same. Most of us operate at cabin altitudes equivalent to about 8000 feet. That's about 550 millimeters of barometric pressure and the oxygen levels have dropped from a normal -- the 160 millimeters down to 110. This hypoxia affects and magnifies the effect of any sedating medications. You put in at end of flight, long day, fatigue after a -- a maximum mission is basically equivalent to having about two drinks of alcohol. We -- when we add in any sedation from any medication, you get a sedagistic effect.

So, we've had company policies that work. We can try to educate individual practitioners. It's very difficult to do that because the individual practitioner is the advocate of the patient and will absolutely never tell their patients, "You can't do what you want to do." And I've seen extremes in this.

It -- really, to give you an example, I -- I had a recent case where a driver literally ran into a parked vehicle that had warning lights and a flagman, and the driver was taking prescription amounts of codeine and diphenhydramine and also had a blood alcohol of .18 and at the time his personal physician evaluated him had a blood alcohol level of .18. And his provider testified in court that that man was not impaired.

When you have these situations where the individual provider clearly is such an advocate for the patient, we're never going to see anybody say that there is no impairment unless they're independent, and they have to be independent to be able to -- to base it because otherwise we're -- we're winning individual freedom with no collective responsibility. And if we don't regulate this we're going to legislate -- we're going to litigate it. The lawyers are going to say who will be responsible and who's going to end up paying the bills, and that could be individual practitioners.

What we'd like to have is strong guidance. One could create a list. The -- the FAA has -- has already, as you've seen, Dr. Hartenbaum presented, a -- a pamphlet that is a very strong advisory for aviators. And it works if everybody reads it. But getting that pamphlet is not universal. Ideally, we'd like to have every single person aware of every medication they take and, even more ideally, the interaction between medications, which is much more difficult and in many cases remains unknown.

So, we're faced with a lot of dilemmas here and it's not an easy -- easy situation to -- to come to the ultimate conclusion of what is safe, what can you go safely and work with, what can you not, and what are individual variations. So, it's a tough problem. I don't have the absolute solutions for you.

DR. ELLINGSTAD: Thank you, Dr. Parmet.

Our third panelist is Mr. Kenneth Edgell with the Office of the Secretary of Transportation and the Office of Drug and Alcohol Policy and Compliance.

Mr. Edgell?

MR. EDGELL: Dr. Ellingstad, Dr. Galson, members of the panel, thank you for inviting me here.

I --

(Pause)

MR. EDGELL: Okay. Back on track. I am going to take the next few minutes -- I hope I can get through it in five or 10 -- to introduce this mountain of information that I have here on -- on the table and leave it with you and offer it as an example of DOT's contribution in the education area.

Safety is DOT's number one objective. It is -- we refer to it as our "North Star." DOT shares the concern of the NTSB and the FDA regarding the complications that can arise if caution is not exercised when any prescription medication and some over-the-counter medications are used. During the last decade DOT has issued extensive drug and alcohol regulations together with guidance and specific education and training requirements. The transportation industry itself has addressed the need for caution when using prescription and over-the-counter medicine.

DOT continually addresses this issue with periodic notices to the industry and with a wide range of educational and training efforts to those with safety-sensitive jobs and those --

DR. ELLINGSTAD: Could you pull the microphone a little closer?

MR. EDGELL: Oh, I'm sorry.

DOT continually addresses these issues with periodic notices to the industry and a wide range of educational and training efforts to those with safety-sensitive jobs, to those -- and to those physicians who are tasked with ensuring the medical qualifications. I'd like to go through some slides to point out some of the actions taken by each one of our operating administrations.

(Slide)

MR. EDGELL: The Federal Motor Carrier Safety Administration develops and periodically publishes easy-to-understand guidance documents and videos that advise medical providers and operators on the hazards of -- hazards of using medications while responsible for operating commercial motor vehicles.

As an example, Federal Motor Carrier Administration has developed an educational video that targets the motor coach industry. This video addresses the use of prescription and over-the-counter meds in relationship to fatigue.

Motor Carriers is working in partnership with the American Trucking Association on a train-the-trainer program for their Wellness Program which targets commercial drivers called "Getting in Gear." This program will address, among other issues, the use of over-the-counter medicine, prescription meds as possible hazards when operating a commercial motor vehicle.

The -- over 350 physicians, medical examiners involved in determining medical qualification for drivers have been trained by the American College of Occupational and Environmental Medicine and more physicians, approximately 3000, have purchased the DOT "Medical Examination Guidebook."

Motor Carriers has traditionally relied upon the medical community to advise drivers about the proper use of -- medications, both prescription and non-prescription.

(Slide)

MR. EDGELL: Federal Transit Administration has been very active in providing training for public transit agencies and their contractors the past two years. 13 fatigue classes, 15 substance abuse classes, eight drug and alcohol seminars, 13 seminars are planned for 2002. Special emphasis has been placed on education for both management and employees about the safe use of all medications, including over-the-counter drugs. All of the major transit systems have incorporated over-the-counter and prescriptive meds into their policies and driver training orientations.

(Slide)

MR. EDGELL: The Federal Rail has issued a safety advisory on the recommended practices for safe use of prescription and over-the-counter meds by safety-sensitive railroad employees. That initiative involved into the Federal Rail publishing and distributing a compliance and enforcement manual which established the program standard for prescription and over-counter medication use. Federal Rails has also provided numerous presentations and classes to railroad labor and management leaders which underscore the seriousness of their training efforts.

(Slide)

MR. EDGELL: And as a follow-up to the -- the DOT's complete commitment to safety, when Lamar Allen, who was a panelist before you yesterday, does a railroad inspection tomorrow, I can assure you that he will look carefully at the railroad to determine that their policy that they have is fully implemented in this area of concern.

(Slide)

MR. EDGELL: Federal Aviation has published information for airmen which addresses the dangers associated with the use of specific over-the-counter drugs as well as the dangers associated with the use of prescriptive medications. Examples include the "Aeronautical Information Manual" developed for civil aviation pilots which devotes an entire chapter to the medical facts for pilots; the "Medical Handbook for Pilots," which contains a chapter "Drugs and Flying;" and from the "Medical Facts for Pilots" a brochure entitled "Over-the-Counter Medications and Flying."

In addition, the FAA has developed information specific for the aviation -- for their aviation medical examiners. These include quarterly publications from the Federal air surgeon and the medical bulletin, which contains relevant articles and technical reports on the effects of medications and flying. A series of presentations has been developed by the Civil Aeronautical -- Aero Medical Institute. These are known as CAMI's aviation -- courses. CAMI has also developed the basic and beam aviation medical -- examiners' seminars which are conducted across the country and two self-administered training courses.

(Slide)

MR. EDGELL: U.S. Coast Guard has the Motion Marine Personnel Physical Examination Report. This is a report -- this is a form that standardizes the physical examination of all holders of Coast Guard-issued licenses and merchant mariner documents. This form is used for navigation and vessel inspection circular, which specifies -- specifically addresses dosage, purpose, and side effects of medication.

The Coast Guard has embarked on a new crew alertness campaign. The Research and Development Center has been working with the maritime industry in generating interest and awareness of crew alertness and crew endurance management. This system was designed to allow company management and crew members to use objective methods to constantly improve the work plan, the safety, and the personnel endurance.

(Slide)

MR. EDGELL: National Highway Traffic Safety Administration is involved now in the large truck crash study with the Federal Motor Carrier Safety Administration. This study is to determine the causes of serious truck crashes so that most -- so that the most effective measures -- countermeasures to reduce the occurrence and the severity of the large truck crashes will be implemented. The study will determine the causes of serious large truck crashes and the part of the assessment includes significant information related to the use of prescription and over-counter medications, asking about 41 different prescriptions and 15 over-the-counter medications. Data will be collected on a voluntary basis but not from the standpoint of toxicological testing by the National Automotive Sampling System and law enforcement at 24 sites across the country.

This is a four-year effort, 250 of a planned 1000 accidents results have been collected to date and a final draft report and preliminary results should be available in 2003.

(Slide)

MR. EDGELL: The DOT strongly supports clear, consistent, meaningful, easily recognizable warning labels on prescription drugs and over-the-counter medications. Such a meaningful label would be helpful as a tool as a constant reminder of the side effects of medication. A meaningful warning label would be an excellent memory jogger for all of those involved in transportation.

The DOT's position is that we believe that the underlying medical condition for which these listed medications are taken is of utmost concern; that individual reactions to medications vary, creating a case-by-case determination; that drug interactions are another highly confounding concern that, again, leads to a case-by-case evaluation due to beliefs that the solution is very complicated but it centers around a system of continual education of all the key safety components, the DOT medical examiners, and the DOT safety-sensitive employees. Thank you.

DR. ELLINGSTAD: Thank you.

Questions from Technical Panel/Parties and Discussion

DR. ELLINGSTAD: We'll turn to the Technical Panel. Lead-off questions from Dr. Garber.

DR. GARBER: Thank you. Thank you all for -- for being here and thank you for your presentations.

I'd like to start out with a couple of points of clarification from Mr. Edgell, if I may. The training, the American College of Occupational and Environment -- Environmental Medicine training that -- that you listed under the FMCSA actions, is that DOT-sponsored? Does the DOT pay for that?

MR. EDGELL: No, not to my knowledge.

DR. GARBER: Okay. And --

MR. EDGELL: -- that's one-day training. That is -- would be paid for by those participating.

DR. GARBER: Does the DOT in any way fund that training?

MR. EDGELL: Not to my knowledge.

DR. GARBER: Okay. Does the DOT publish a book that goes along with that training?

MR. EDGELL: I'm not sure.

DR. GARBER: Okay. So, in spite of the fact that this is an FMCSA-listed activity, the FMCSA in fact does not have any role in providing that training?

MR. EDGELL: I'm actually not sure what the Federal Motor Carrier Safety Administration's role is in the administration of that training, if they participate in the training. They could very well. The Department of Transportation, and I'm speaking of other types of training or perhaps this is an analogy to be made here, we train medical review officers.

DR. GARBER: Right. No, I'm sorry --

MR. EDGELL: Now, --

DR. GARBER: -- I guess -- I guess the question really was to that specific issue of the -- of the training provided by the FMCSA.

MR. EDGELL: They -- they -- they -- they could participate in that with staff members. I personally do not know. I can find that out for you --

DR. GARBER: Does --

MR. EDGELL: -- and give you that information.

DR. GARBER: -- I know that Dr. Hartenbaum is a member of the American College of Occupational Medicine and also the -- the -- the editor of the text used, I believe, in that training. Can you comment on that, Dr. Hartenbaum?

DR. HARTENBAUM: Actually, there are several pieces. First of all, the textbook is not through ACOM. It's not through the American College of Occupational Medicine. It was an independent book put out, really, as a result of the negotiator rule-making committing merging the exam and the licensing process.

We recognize that information was available but it was not easily accessible. You had to all the agency and request the conference reports. What we did at the time was we took the conference reports and basically summarized them. We included information on the medications as it was listed in the conference reports, which were recommendations. It also included recommendations for an FHWA-, at the time, accepted and trained psychiatrist to evaluate the use of any of the psychiatric medications.

So, the book came out of the conference reports. They were recommendations. They had no regulatory force and could not really be held to a standard.

Of course, this came a couple years later. It is fully run by ACOM -- ACOM members. We did have a member from the FHWA speak several years ago, just talking about the regulatory issues.

What we've tended to present, again, are recommendations, regulations, and guidance material where any exists. Much of it is many years old. Our examiners continually tell us that they really can't enforce many of the recommendations on medications because it's a matter of opinion. These are recommendations. They're not codified. There's no supporting material available and there have been numerous lawsuits filed against companies and examiners that say, "I'm sorry. I can't qualify you while you're on Xanax or while you're on Adivan." And they go back and they get the treating professional to fill out a questionnaire and he says, "He's safe to drive. He's fine to drive."

ACOM would welcome an opportunity to work with the agency to get this sanctioned information. Right now it is independent and partially opinion.

DR. GARBER: Okay. And just, again, so -- so that I'm -- I'm very clear on this. And this is something that is independent of the DOT, this -- this guidance and these courses? Okay.

MR. EDGELL: But if I could add here, these courses in training the medical examiners would no doubt rely heavily on the DOT-published regulations, such as 391 which covers the medical examination criteria and the support information, the question and answers, additional guidance that is published to go along with 391.

And all of this is available on the DOT Web site. There's a very elaborate Federal Motor Carrier Safety Administration home page with this information spelled out categorically. And I would think that -- that the Motor Carriers would work very closely with ACOM or any organization to try to train to be in -- in a cooperative partnership. I just can't imagine anything else.

DR. GARBER: Which -- which actually brings me to my next question. Dr. Hartenbaum, do you believe that the guidance that is available that Mr. Edgell just described on the Web site and through other DOT sources, regulatory or official guidance sources, is adequate for the average commercial vehicle operator, commercial truck driver in particular, out on the -- out on the roads? Are they able to make a determination with the resources they have available as to whether a medication should or should not be used by them?

DR. HARTENBAUM: What the first -- is do medical examiners know the information is even out there? We've trained 350. There are thousands of individuals who can do these exams, from physicians, both M.D.s and D.O.s, nurse practitioners, P.A.s, and in some states chiropractors can medically qualify a driver as being able to drive. That includes evaluating the medication. So, first of all, we're not even coming close to reaching the -- the examiners.

Secondly, the information is incredibly vague. The recommendation on -- is very clear and it says that Elavil should not be used. But that's not codified. If an examiner or company says, "I'm sorry but you're on Elavil. I can't qualify you," there have been and there will continue to be lawsuits because these are not codified or officially -- recently updated regulations. They come from conference reports that are about 10 years old and that is where we're getting our resources from.

We are with the second edition of the book, with the new recourses, we're trying to pull from medical literature but it's still recommendation and that's only reaching a very small percentage of the examiners.

DR. GARBER: And with regard then again to the drivers themselves, would -- would you suggest that -- that a large percentage or a small percentage of them is in reach of this information?

DR. HARTENBAUM: That'd be a very small percentage. If there was a brochure or pamphlet available similar to what the FAA has produced, that could be distributed either through the companies or through the examiners. That would probably be a good starting point.

DR. GARBER: Thank you. And Dr. Parmet, sort of a similar question. Is the -- is the guidance that is provided by the FAA currently effective in reaching the entire pilot community? And again here, I recognize that a lot of your experience has been in the commercial air carrier operations where there -- where there's often a physician such as yourself supervising. But in air taxi operations or commuter operations where there may not be as -- as robust a medical program, do you feel that those pilots are getting the official and -- and necessary information to make the appropriate decisions?

DR. PARMET: I think initially the information's available. And when we're dealing with pilots we have a different group of people who are more interested in what's going on because the tolerances are so much tighter. Certainly, at the fundamental level of the medical examiner we have a very different environment. We only have about 7000 aviation medical examiners in the country. You cannot just pick up and do a physical. You must go through a mandatory 40-hour training course from the FAA. You not only -- having done this, every exam you do is reviewed by the FAA. Your -- everything you do is tracked by the FAA. You must have continuing education and document that in the FAA courses.

There is no way that any medical exam in contact with the medical community through the FAA is done without FAA information, sponsored oversight, and continuous training. The FAA provides us with a newsletter that comes out on a periodic basis. So, medical examinations have continuous input from the FAA with advice to the medical examiner and we pass that on to our pilots.

And at the commercial level it works extremely well. At general aviation it's much less so and a lot of it's relied on their private organizations, particularly AOPA and EAA, which are very helpful and they work closely with the FAA on that issue.

In between are air taxi, some charter operations, and what we -- we like to call Agro Americans out in my part of the world, crop dusters and agricultural aircraft. And a lot of these folks, even if you gave them the information, wouldn't pay any attention. So, it's -- these are sort of our -- our equivalent to independent operators from the truck drivers.

But the information is -- is much more readily available. There are FAA publications that are -- that are reasonably good. I'd like to see more detail and better labeling on the issue, but we're in a much better situation on the aviation community than -- than the other agencies are.

DR. GARBER: Thank you. I think those are all my questions for now.

DR. LAUGHREN: I want to try and contrast this with -- with the -- the program late in the day yesterday when the military was talking about their approach to -- to controlling medications. So -- just so I can understand exactly how it happens in commercial transportation in this country, for example, a commercial truck driver is having problems sleeping, so goes to his physician and gets prescribed a medication. Does that have to be cleared with -- say if it's a -- if it's a large company, large trucking company. Does that have to be cleared with the medical examiner at the company?

DR. HARTENBAUM: In the majority of companies, no. Some large companies may require reporting. Most of them do not. Most of them leave it just to the -- talk to your doctor and discuss it.

DR. LAUGHREN: Okay. How about in -- in commercial air? Would -- if a pilot is prescribed a hypnotic, would that have to be cleared with -- with the medical examiner in the company?

DR. PARMET: Well, the answer is individual companies might have a policy yes or not, but absolutely every pilot would be knowledgeable that if they're on a prescription medication that must be reported to the FAA before they're cleared to return to service. And most commercial air operators would tell any -- any pilot if you have newly prescribed medication you are not cleared to fly and not cleared to return to duty until you have -- and blessed by the FAA or you're no longer requiring that medication.

DR. LAUGHREN: Okay. So -- so, --

DR. PARMET: We fail safe, basically.

DR. LAUGHREN: Okay. So, it would have to be cleared by -- by someone presumably following FAA policies about that. Then, my question is, what -- what are those policies? Do you have -- do you have lists of -- of hypnotics that are acceptable or not acceptable in the same sense that the military might -- might have those?

DR. PARMET: For most of the hypnotics the blanket answer's no. They're -- none of them are accepted.

DR. LAUGHREN: Even a very short half-life one would not be acceptable?

DR. PARMET: Yeah. In -- in general, they're -- and I could be corrected because I can see that Federal air surgeon has a representative, but in general, no, they're not permitted. If somebody is not actively flying and needs to take something, they cannot fly for at least 24 hours so that the effects of that are worn off before they return to duty.

DR. LAUGHREN: Well, it sound -- it sounds like that's an even more severe policy than is applied in the military. I mean as I -- if I understood it yesterday, very short half-life hypnotics were considered acceptable. I think the term was "bottle to throttle time" four hours or something like that. So, it sounds like it's -- it's even a more strict policy than in the military.

DR. PARMET: Well, the military is mission-driven. And if they want somebody to get their rest right now they tell them to get their rest right now. And when I was in the military we would prescribe what we called "no-go pills." We would give you a medication to put you to sleep now and then when we wanted you awake we would give you a medication to make you alert, even to the point of prescribing amphetamines. And we know short-term that this is safe. But we also had much higher acceptable level of risk in military aviation. There's people shooting at you.

In civil aviation, you don't have to go. We can get somebody else to do your job, so we don't have to accept that risk. We can bring in a back-up pilot to fly that flight. Why should -- why should we accept the risk that somebody may be compromised in their cognitive ability?

DR. LAUGHREN: I guess the only difficulty then is that if -- if the -- if the consequence of taking a hypnotic to a pilot is that he or she won't fly and if they, you know, they feel they need that, then it might encourage deception.

DR. PARMET: This is true, and this does happen. And I -- you know, I've had informal conversations with the Pilots Union physicians and they're aware of it. And the pilots are aware of it. We haven't quite figured out how to get around it yet.

DR. LAUGHREN: I guess the only other point I wanted to come back to -- this is for Dr. Hartenbaum. I had -- had the sense from what you were saying is that -- that one severe limitation on -- on what kind of education you can provide is the information available on drugs and in particular the fact that it's hard to distinguish among drugs based on -- on, for example, prescription labeling, that -- that the information is often somewhat vague. It encourages caution but doesn't really make the kinds of distinctions that might be -- might be useful to an examiner in making recommendations about, you know, one drug versus another for any particular class of drug.

DR. HARTENBAUM: Most of the examiners are seeing the driver for one time over two year exposure. The person who is prescribing are the treating professionals. And when you go back and say, "Is this person having side effects? Are they safe on this medication?" invariably the treating will say, "He's fine. He's not having side effects." So, until there's a list that says, "These are not permitted" -- right now the -- FMCSA prohibits the use of insulin and medications for seizures if you're driving a truck. And we still have neurologists and endocrinologists who keep writing, "Okay to go back to work. Safe to drive," yet he's on insulin. But we don't have the same kind of force behind saying, "He is on Elavil. He really isn't safe to drive." "No, he's my patient. I know him. He's better now than he's ever been." And the companies will try and deny that and we'll end up in court.

MR. EDGELL: One of the things I would like to add on your first statement, just to point out that it is a requirement of any driver -- and -- and drivers, that's the -- the largest portion of the transportation industry. 7 and a half million, we estimate, out of the 8 and a half million safety-sensitive employees regulated by the Department of Transportation. Those drivers are required to any time they go to a physician are -- and have medication prescribed are required to tell that physician, "I'm a driver," so that the physician can provide the proper warnings with any medication.

And maybe it's -- the defense -- being somewhat defensive or -- or just naive in this area, but I would like to think that these individual providers are more than advocates of the patient in doing these physicals, that they are advocates of safety. That's their purpose in this. And -- and we are having faith in that system.

DR. GALSON: Your colleagues next to you are shaking their heads.

DR. HARTENBAUM: I'd like to respond on that one. There's really two different --

MR. EDGELL: They are the physicians. I'm not.

DR. HARTENBAUM: There's really two different examiners we're referring to. One is the medical examiner that the company may send the individual to, and that contact is only once every two years. The other is the prescribing physician, who actually may end up being the examining physician because some companies allow a driver to go to their own personal physician, who generally doesn't even --

We have found in occupational medicine that we frequently get return-to-work notes. "Can return to work." But he's having passing-out episodes. "Do you know he works at heights?" "Oh, I didn't know that." "I started him on insulin. He had a seizure last month. He's fine to go back to work." "Do you have any idea what he does for a living?" or even ask what the person's job is? And doctors prescribe the sedating medications. I'm not sure why they would prescribe it without thinking that they're driving a car or just working around with other equipment at home.

So, I think too often physicians just really don't think about the potential side effects of their medications or what the person does for a living.

DR. TEMPLE: Mr. Edgell, you just -- before I get to my main question, you said that drivers are required to tell their treating physician their -- what their job is. What does that actually mean? How are they required -- what if they violate -- is it a law?

MR. EDGELL: It is -- it is a -- requirement of DOT regulation for motor carriers and it is to be conveyed to the driver by the employer that if you go to a physician that you tell that physician that you are a driver when they're prescribing any medication in the interest of safety. And that is to be conveyed by the employer to the driver, and we write our rules addressing the employer as well as the driver.

Also, companies are authorized to have policies that if you're on prescription medication it's the company's -- is the -- is authorized to know that -- stated that most companies do not have those policies in place. I would think that the large companies do. They have a greater appreciation for litigation liability. But we are a small business industry.

DR. TEMPLE: Well, one of the things people ask us more and more at FDA is whether we know how our various risk management programs are actually working. We have all kinds of labeling and advice and if it was followed everything would probably be perfect. But we know that people don't follow it.

Really, for all of you, do we have any idea how much transmission of knowledge and then -- and then appropriate performance there is? There's -- it sounds like there's masses of literature that give all good advice people would need if they became aware. Do we have any idea what the penetrance of that is? Do most people know? And if they do know, do they say, "Oh, well, I just -- I've got a cold. I'm going to take that stuff"? Any -- I mean these are susceptible to surveys and sampling. Is there any of that?

DR. HARTENBAUM: I guess just even looking at some of the accident reports that's come through the NTSB where operators at all commercial modes have been found to have things like Benadryl in their system.

As far as reporting to your personal physician, I'm not sure that even makes a real difference. We had an accident in New Orleans a couple years ago where every treating physician knew he was a bus driver. It was on every hospital admission, it was on every hospital form, every physician encounter, and yet they kept releasing him back to work despite medical problems and despite medications.

So, I think educating the healthcare provider has to be an important part of this process. We can't just stop educating the employee because they'll go back and talk to their doctor and the doctor will say, "Oh, I guess you're fine."

DR. TEMPLE: But it -- it would be possible, for example, to conduct a survey among practitioners, wherever the people who are doing this, to learn about the level of consciousness of those things. I mean those are all expensive and I understand why things don't get done, but there isn't -- nobody's tried to do that sort of thing, I take it?

DR. PARMET: Well, --

DR. HARTENBAUM: I'm sure the College -- the American College of Occupational Medicine would be thrilled to work with the FDA in --

DR. TEMPLE: DOT --

DR. HARTENBAUM: Whoever wants to work with us.

(Laughter)

DR. HARTENBAUM: We'd love to get the grant.

DR. PARMET: Well, let me -- let me say, the FAA has actually been doing this because they have a much tighter control as well as investigating all the fatal accidents, and they've got a continuing surveillance both by FAA and NTSB together. And they have the statistical data. I mean when you look at that end point, rare as it is, you find that between 25 and 35 percent of fatal accidents have some sort of drug on board at time of the accident. Some of these drugs are prescription drugs that are prescribed and approved by FAA. It's just a survey that's been done. But it's -- some of them, about 15 percent, are over-the-counter drugs. And a small percentage are controlled substances that it was illegal to fly with under the DOT 5.

So, we -- we know it's out there even in a organization and a group of -- of pilots who are aware of the risk. They're much more aware, they're much better educated on the average than the other agencies. They're much better controlled. The examiners are all trained, which you cannot say in the other agencies, except the Coast Guard is working on theirs.

But certainly, the DOT examiners of -- of commercial drivers, I would say the majority of them have had no training whatsoever. They're just told to do the physical, and they don't have to be a physician, they don't have any training, and there is no feedback as to whether they've done the job correctly or not. I can't tell you how many drivers' physicals I may have failed somebody on and the individual go down the street and have someone else do it and pass them for egregious conditions.

DR. ELLINGSTAD: Could I interrupt? To follow up on that point, we -- we've got representatives of all of the transportation modes here and we're participating and we're sort of pretending that we have equivalent kinds of systems going on. But we're certainly hearing of substantial differences in terms of the kinds of infrastructure both to monitor and regulate operators as well as to provide education and training and information.

Perhaps it would be helpful, maybe starting with Mr. Edgell, if you could just explain for us what the infrastructure is with -- in each of the -- the modes with respect to the -- the medical examiner, you know, cadre and what -- what role they have with respect to operators either to monitor what they're -- they're taking or to -- to deliver this kind of information?

MR. EDGELL: The -- starting with the Federal Motor Carrier Safety Administration drivers, the drivers are the safety-sensitive position. And they are required, if they're driving interstate, to have a physical to determine their medical qualifications for driving.

DR. ELLINGSTAD: Who delivers the physical, and does FMCSA license or -- or otherwise --

MR. EDGELL: They --

DR. ELLINGSTAD: -- certify these examiners?

MR. EDGELL: They -- the Motor Carriers allows the states to determine the -- who -- who a medical examiner may be: physicians, some places physician's assistants, nurse practitioners, and at this point or not even chiropractors if they're allowed to do physicals in that -- in that state.

The intrastate drivers, most of the states have incorporated the requirements of the regulation that I mentioned, 391, for their state commercial motor vehicle operators. Aviation has specific physical requirements that have been discussed on the regular basis, periodic basis, one to two years, some three years.

The transit industry does not have specific requirements for physicals. However, most of the transit operators are strongly influenced by Motor Carriers and by the rail industry and have incorporated those same physical requirements in their transit operations -- all of the major transit systems have physical requirements -- medical qualifications for their operators.

And the maritime industry has medical qualifications for anyone with documents, issued licenses and merchant mariner documents.

DR. ELLINGSTAD: One follow-up. I assume from what I've heard that someone could probably produce a list of all of the FAA-certified medical examiners by this afternoon if we asked. Could the same thing be done for any of the other modes?

DR. HARTENBAUM: No.

MR. EDGELL: No, I don't believe so.

DR. HARTENBAUM: No. There's no way you can do it for highway, and you can't do it in rail, either. It can also take a little bit for transit. I know transit right now -- a large number of transit operators are covered either under FRA or FMCSA requirements. And the companies that have those requirements are meeting them.

For their operators who do not fall under one of those two agencies, there are often -- maybe some similar exam but not always, not requirement. For highway, the examiner can be anyone who is licensed by a state to do an exam. There is no formal training requirement. The examiner is expected by regulation to be aware and knowledgeable of regulations and training and -- regulations and additional material.

There was an informal study done about six years ago asking occupational physicians if they were even aware of the conference reports or the advisory criteria that was available and a significant portion of them said they had no clue it even existed.

There was also a study done in the midwest with eight states where they were looking at every single examination done, and over half of them had errors made and these were examiners that knew they were being reviewed.

For rail, the company can -- can have the exam done by any examiner they choose. And it's only -- locomotive engineers are required to be examined and it's only vision, hearing, and color vision.

DR. ELLINGSTAD: Thank you. I'm sorry, Dr. Temple.

DR. TEMPLE: No, that was very instructive, actually. I think I'm -- I'm done.

DR. SWEENEY: I have a question for probably Mr. Edgell. What has DOT done for non-commercial drivers in terms of informing them about the dangers of medications?

MR. EDGELL: Non-commercial drivers?

DR. SWEENEY: Yes.

MR. EDGELL: Taxi cabs? Private autos?

DR. SWEENEY: Passenger cars, yeah.

MR. EDGELL: Passenger cars? I really can't address that question. I mean we have not -- we participated with this -- with the City of New York when they had some questions regarding drug testing their -- their taxi drivers, but on -- on request we will provide information. But specifically providing information to private drivers, I'm not aware of anything specific that we -- anything targeted that we have in -- in the Department.

DR. SWEENEY: And yesterday -- for any of the panel members here, yesterday we heard in the late afternoon about the expanding role of pharmacists in counseling patients who come in for prescription medications. Have any of the modes worked in the -- with the pharmacy industry?

DR. HARTENBAUM: I know that at least one pharmaceutical company has been working with the American College of Occupational Medicine trying to make sure that the op docs know about the sedating versus non-sedating antihistamines. But not directly working with the pharmacists.

DR. GARBER: I've just got one point of clarification. There -- there is -- is there in fact any list, either permissible medications or non-permitted medications, that an operator could access if they wanted it that is approved by the DOT? In fact, does -- does the DOT publish any list of either approved or non-approved medications that an operator could use either in conjunction with their physician or -- or on their own to determine whether a medication should or should not be used?

MR. EDGELL: We do not have an approved list.

DR. GARBER: And again, just as a point of clarification, I know Dr. Parmet indicated that certain hypnotics would not be permitted for 24 hours, but my impression is that that was more of a guidance either provided to the medical examiners or something that the company provided rather than FAA guidance, is that correct?

DR. PARMET: For -- for general purposes that's correct. The FAA does have an internal list that they use with their air traffic controllers, but in theory -- not supposed to be using.

DR. GARBER: Okay. And then, just -- I really -- I know that I've -- I've probably been a bit harsh in my questioning, Mr. Edgell, but I did want to point out and -- and perhaps give you the opportunity to point out how -- how much leeway does the DOT actually have in enforcing any rules that it would -- might require with regard to medications? I mean how would the DOT in fact be able to enforce any rules were they to put them in place that were specific to specific medications?

MR. EDGELL: Well, enforcement is certainly a big concern with the Department of Transportation because we have so many companies, so many employees. In the motor carrier industry alone you're talking hundreds of thousands of employers, millions of employees. It -- it would be quite -- quite difficult because the enforcement is only -- it's most effective when done at the company's -- at the employer's principle place of business. And the resources are -- are a problem.

DR. GARBER: Thank you. I think that's all we've got for now from the Technical Panel.

DR. ELLINGSTAD: Thank you.

This morning I think we'll start with the Transportation Industry group.

DR. FAULKNER: Tom Faulkner, ATA. I have a question from colleagues here for Dr. Hartenbaum. Is it your position that all medical providers performing DOT medical examinations be trained, certified, and/or registered on an approved DOT list similar to what the FAA has?

DR. HARTENBAUM: That's a difficult question. My personal opinion is, yes, there should be some mandatory information dissemination, mandatory requirement that they demonstrate that they understand the questions.

There was a committee formed several years back and we've been waiting the past three years I guess now for a rule-making where the question of should there be certified examiners. One group proposed certified examiners similar to the FAA system. One group -- one party of this committee said, "We'll sign a form that we'll do the exams right," which clearly they're already signing the form, they're still not doing it right. And the third group recommended giving the information out and answering a series of questions and answers to demonstrate understanding.

Part of the problem with certifying is that there are not absolutes. Intentionally, a lot of these are left to the discretion of the examiner. There is not a pass-defer type system as there is in the FAA. An AME can examine an individual and say, "You don't meet these criteria. I defer you," and that goes to the regional flight surgeon and it goes up the ladder for review.

In highway, the medical examiner, whoever that might be, whether they have the information or not, has the final answer. There is no appeal. There is no further up-the-ladder to go. So, my concern with certifying is how do you test an absolute yes-no answer when there is no absolute yes-no answer? You have to look at each individual basis.

Do I feel there should be mandatory training? I do there -- do feel there should be some mandatory training of some sort. Does it need to be for the FAA? No. We would love to work cooperatively with, you know, the agency on these courses.

DR. FAULKNER: Another question. We will be hearing from the International group, but for instance, in France they have by mandate so many doctors per so many employees, a pretty tight ratio. And as we heard yesterday with the military, one flight surgeon will be serving, you know, maybe 100 pilots along with the other personnel. In the States here 7500 AMEs, or aviation medical examiners, to half a million pilots.

What's the panel's thought about something similar to what they have in other countries where you have a mandatory number of physicians, maybe increase the number of AMEs to be more -- better resource or accessible to employees in the transportation industry?

DR. HARTENBAUM: -- doing commercial driver exams?

DR. FAULKNER: No, I -- well, that's another thing is to have a, maybe, combined specialist that, you know, we've heard here a maritime ground transportation -- commercial driver's license, aviation. Individuals that know the very limits and the training in that and have that safety responsibility rather than -- I mean they're still patient advocates, obviously, but again, the -- the public good, shall we say, in mind as well.

DR. HARTENBAUM: That's probably not a bad step but I think you could do it a simpler way by making certain that examiners -- there are sufficient examiners and they're sufficiently provided the information.

DR. PARMET: If I can address that -- I was part of one of the pilot programs about seven years ago. And we trained all the individuals in the State of Missouri who were going to do DOT driver examinations. We got organized, we trained everybody in a series of seminars. It wasn't nearly as extensive as -- as the FAA, but we weren't dealing with the same demanding environment of altitude and acceleration. And we were also dealing with people who were fairly experienced already. We certified the people in short order.

I think we greatly improved the awareness and the quality of the examinations done. For the first time people began to get feedback on the examinations they were doing. Somebody was looking at their product and giving them a grade. Because right now there is nothing done. For the majority of these examinations under DOT commercial drivers there is absolutely no feedback. You don't know if you're doing a good job or a bad job. You may be the best, you may be the worst, and you have no idea. And I think it's very feasible to do that and we've proved it.

So, I -- I actually support something parallel to the FAA system. I think that would be an excellent idea. It would promote safety. It's going to cost, but it would promote safety.

MR. EDGELL: We certainly -- if I could comment on that, the advocates of safety are also advocates of training. If we get to establish a -- a way to get this information to the physicians in a better way I think the Department would certainly promote that idea. We do have guidelines that have been put out that I mentioned. The Motor Carrier industry has developed a physical examination form that we certainly want to have in the hands of all of those examiners doing these physicals and a better way to get that information out.

We certainly -- I think what I hear is that we need to do more and the needs are very broad -- tremendous amount of individuals -- it's a huge problem. Huge, huge issue.

DR. FAULKNER: Last question, actually, is -- it's from the -- since I gotcha, Mr. Edgell, comment. Any plans on the horizon to change the DOT 5 drugs tested for?

MR. EDGELL: They're at the -- at OMDCP, the Office of Management and Drug Control Policy and Health and Human Services Drug Testing Advisory Board, there has been a lot of attention lately made to the ecstasy drug. And that is -- has been proposed in some guidance -- some efforts by the Drug Testing Advisory Board on their -- on their guidance for alternative specimens to add that drug. But the protocols are not developed. It would be an amphetamine class and that is the only thing -- and I'm not saying we're going to do this. I'm just saying that that -- that is the one that's making its way towards the stove and could be a possible addition to the amphetamine class of drugs. That's the only one that I'm aware of.

That is -- if we did that, it would -- sometime in the near future, two, three years probably.

DR. FAULKNER: Final question. This is more, really, for the panel. What about -- there's been approaches from some people or employees in particular saying when it comes to labeling perhaps putting "DOT-prohibited drug." Your thoughts on that?

MR. EDGELL: The idea of a list, a tremendous amount of medications, these medications, the condition is more important than the medication you're taking. The physicians yesterday were talking about it. Can I produce a list that is -- is totally safe? And one physician says, yes, probably -- only problem in one in a thousand. One in a thousand with 8 and a half million people still gets you a pretty large number that could be potentially problematic.

Everyone said that, well, you have to have a caveat here that taking it at the proper dosage because if you're using it incorrectly -- and then the -- the cross reaction with other medications you might be taking. So, once again, you ask tough questions.

DR. PARMET: I -- I'd like to think that would be a great idea, but the -- there are some -- some medications that even at minimal dose would not be safe. The problem is that you say "no go" and the assumption is that that -- if that's not on the label everything else is okay.

DR. HARTENBAUM: I think having a list of at least some absolute "no’s" would provide some start, a way of getting around this for both examiners and for providers. I used the example of Elavil earlier. It was recommended Elavil should not be permitted but it's recommended. We know Elavil is significantly -- its effects last for a -- really, for a long time. If we had something that said that these are absolutely nots and these are to be reviewed, it would give the companies and the examiners something to stand on.

DR. PARMET: You could in fact have a prohibited label, a mandatory "you gotta check before you can do this," and then this is generally okay. Although I -- I can tell you in my workers' compensation practice I have a lot of people who tell me they can't possibly work if I put them on ibuprofen. It puts them right to sleep. Now, if they're taking it for a headache it's okay but not with a work-related injury. Everybody's individual.

(Pause)

MR. SPENCER: I'm Todd Spencer with the Owner-Operator and Drivers Association. And I'm not going to contend or -- that I'm going to speak for anybody else at the table, but yesterday I had -- I had real difficulty with the sedating effects of this particular meeting.

Now, this morning --

(Laughter)

MR. SPENCER: -- I've had no such condition. I felt the arrows several times and I think now and then somebody really needs to speak up and say, well, wait a minute, let's get with the real world.

Clearly, I think the best we can hope for from this meeting is some guidance about what is acceptable and what's not. Largely everything else is a gray area. It's important, I think, for us to realize the people that we're working with.

Now, in -- for example, I don't know very many people of any occupation and doing anything that aren't aware that things like Benadryl and other over-the-counter cold remedies or -- or drugs for allergies can make you -- can make you drowsy. It doesn't make any difference what they are. Most people know those things already whether they're truck drivers or pilots, and I cannot imagine any scenario where pilots or truck drivers or other operators of equipment aren't especially aware and keen on those particular issues. And those are -- any kind of over-the-counter stuff you're only going to take as a last resort if -- if -- because the symptoms of the problem are going to create more of a safety problem than the condition that might result from taking an over-the-counter medication.

Now, in regard to -- so you're not going to do that unless you -- unless you really have no other options, and then you're aware of those things.

In my experience in commercial trucking, oftentimes -- oftentimes doctors are going to be conscientious. If it's your personal physician, then he's going to know something about you. And yes, he's going to be your advocate but he's also going to be -- he's also doesn't want you to die. Now, that's going to be a personal physician. So, he's going to tell you straight in terms of -- in terms of what effects any kind of a prescription medication might have on you. He's going to provide you the information.

Now -- but not all doctors are going to be equal when it comes to this. We hear -- there are instances where there are company physicians with motor carriers. Now, the way the motor carrier industry works is that -- is that they need -- they need drivers. The -- the biggest segment of trucking is the truckload carrier industry and this is the segment that goes through drivers like oats to a horse.

A hundred percent turnover is the industry norm. Now, do I think a company's medical doctor is going to necessarily be more conscientious about things like that? Not a chance if they've got a truck that needs a driver. Not a chance. They'll send him down the road.

Now, in the practical world, in the -- in the practical world, we have anywhere from 5 to 7 and a half to 10 million commercial drivers. I don't care whether the driver works for a small company or the biggest company in the world. None of those drivers are going to report to the company that they're taking medications. They're not going to do it and there's absolutely no power on this earth that would make them, no law we could pass. It's simply not going to happen.

We need to provide better education to truck drivers and perhaps to pilots and some others. Right now there's no formal education of any kind, not in driving or anything like that required, for truck drivers. None whatsoever. And unless -- unless it's mandated there -- there won't ever be any real meaningful training that truck drivers get. There won't be any.

There are opportunities, as I said previously. Many -- most people are aware of side effects that are common with some substances but not all. In the trucking industry what we've seen over the past decade is a tremendous growth in immigrant drivers operating trucks. Many don't speak English. I'm thinking they don't speak English and I'm thinking they would be at a real disadvantage in any of these types of things because I'm not aware of any over-the-counter substances that basically come with different languages on the label. Maybe there are some, but I suspect we have problems there that could be addressed. I'm not exactly sure how we do them.

Now, is -- and I know there are -- I would agree that there should be substances that should be simply "yes" -- "yes" or clearly "no." But in other instances I think drivers can safely drive with over-the-counter medications and -- and many -- many, many, many have done it for years.

Now, probably to underscore my comment about how trucking works, a few months ago there was a driver that took a truck into the capital in California. Now, in retrospect, I kind of wish that driver had have had some Elavil in his blood because maybe he wouldn't have made that decision. But -- but that's basically the way trucking works. Thank you.

DR. ELLINGSTAD: Was there a question embedded in there, Todd?

(Laughter)

DR. HARTENBAUM: If there was I'd like to make a comment on that.

DR. ELLINGSTAD: I -- I am glad that -- that we aroused you a little bit. I -- I despaired of surviving an entire public meeting without a word from Todd Spencer.

(Laughter)

MR. SPENCER: Actually, I need to add one more just to set the record straight.

(Laughter)

MR. SPENCER: I mean it's important that you have an accurate picture of the real world if you're going to be talking about policies that are going to have any meaningful impact. Dr. Parmet suggested a while ago that independents could somehow be some special problems. Now, I understand the term "independent" covers lots and lots of different areas. The particular organization that I'm here representing are -- is made up of individuals that own -- that own and drive their own trucks. They do this for a living and most do it for careers. In terms of frequency of accidents and severity of accidents, they are the best and safest drivers on the road today. So, I'm hoping that wasn't the "independents" that you might have been suggesting.

DR. ELLINGSTAD: Well, we don't want to cast dispersions on the crop dusters that he was talking about either, so we'll move on to the unions.

DR. PARMET: That's the highest risk activity you can do, so they naturally have more accidents.

DR. ELLINGSTAD: The union table?

CAPTAIN POPIEL: Pretty hard to follow that speech.

(Laughter)

CAPTAIN POPIEL: Randy Popiel, APA.

(Pause)

CAPTAIN POPIEL: -- the FAA actually has a -- a very strict tolerance on -- on hypnotics and depressants. And I guess it's curious to me as to why the DOT wouldn't follow through with -- with something like that, something as to their strict policy with -- with any operator of any -- of any motor vehicle. I think in commercial aviation the -- the grounding time is -- is more than the magnitude of the depressant -- certain depressants that have been prescribed to an aviator are in the -- in the area of -- of three to six months away from the -- of the cockpit of an aircraft.

Any idea why -- why the severity or the -- the concern doesn't follow through into DOT's enforcement of -- of other activities, other drivers?

DR. PARMET: Well, I think in terms of use of antidepressant medications the question is less the medication than the underlying disease, both of which have to be addressed for safety. So, with regard to a minimum of six months -- and in fact right now the FAA will not approve somebody returning to flight duty who's taking an antidepressant medication. If they stop the medication and -- as most of these mental health problems do resolve, we can return to some -- I will have to say for our other safety-sensitive people a lot of them do work on antidepressant medications. About 25 percent of my flight attendants are taking some sort of psychoactive drug and we are aware of the process of reviewing if there is a safety impact.

But again, we're looking more in those cases to the underlying disease process, not the use of medication. The -- the comments earlier were a short-term grounding if somebody was using a medication on a one-time or two-time basis for sleep or some acute problem. It's -- it's not -- not really a disease going on, it's simply a situation that is -- is going to pass in a day or two.

CAPTAIN POPIEL: In the -- in general aviation and also commercial aviation there are mandatory disclosures either on a -- depending on which area you're operating in, mandatory physicals at -- at six months or a year, depending on -- on what your -- your position is in the aircraft and up to two years in general aviation between -- between physicals. And on each one of those the FAA requires a mandatory disclosure of doctors visits and medications being prescribed. Is there any -- is there any follow-up policy with -- with the other industries that require mandatory -- mandatory disclosures?

DR. HARTENBAUM: For rail, no. For highway, the exams are at least every two years and the new form does include a space for any physician you've seen, any medications you're taking. So, that's there.

The -- the driver is required to sign that the information they've provided is accurate and true. So, that's, I guess, the closest you can come to a mandatory. But it's two years.

If a person starts on the medication during that two-year period there is no flag to pick that up. And you know, the ideal waiting period, talking about a period of time until you adjust to the medication and develop a tolerance to the side effects, there's nothing to really educate the drivers that they shouldn't drive until they develop a tolerance or have gotten used to side effects.

MR. EDGELL: The form used in maritime also has similar questions -- past --

CAPTAIN POPIEL: In both -- in both commercial and transportation operators are international drivers and operators held to the same standards as far as disclosures? Is that a question you can answer?

DR. HARTENBAUM: I can answer for highway. There's been agreements both with Canada and with Mexico through NAFTA that we will accept their statement that their drivers are medically qualified. Canada has a rather interesting system with a very detailed book put out, essentially approved by the government, on medical conditions and what's qualified and what's not qualified. Very detailed.

Mexico, we're really not quite sure what they have. But the U.S. has signed an agreement that we'll accept their medical qualification.

CAPTAIN POPIEL: Same hold true with aviation?

DR. PARMET: With aviation we have a requirement that anyone that flies a commercial aircraft into U.S. air space must meet U.S. FAA requirements. And we participate with ICAO, the International Civil Aviation Organization, whose regulations are similar -- tougher than FAA. FAA's actually one of the more liberal organizations in having carefully evaluated pilots for use of chronic problems and chronic medications and permitting them to return to flying. But they have the largest database in the world as well, so I think their -- their decision on that is sound. The aviation community internationally is close to --

MR. EDGELL: Just to add one thing that of the -- with the exception of just a handful of Mexican employers -- carriers, while they do enter the United States they are limited to the travel within the commercial zones -- U.S.-Mexico border. We're still in the process of -- of working that issue for --

DR. ELLINGSTAD: Thank you. Now we'll go to the pharmaceutical industry.

MS. RUSSELL: I'm Corinne with the Consumer Healthcare Products Association. I have two questions aimed at any or all of the panelists. Are you aware that the over-the-counter drug manufacturers have an extensive and ongoing consumer education program aimed at all consumers? And as consumers we know there are many drivers who are drivers, and this campaign is aimed to provide important guides for safe medicine use. And continuing with that same question, I -- I wanted to know if you're aware of an organization called the Council on Family Health, which is a consumer education foundation funded by industry that has averaged over 194 million impressions with print, broadcast, and Internet materials designed to educate people about consumer proper medicine use. And CHPA, our association, has distributed over 6 and a half million copies of various publications, again, about safe medicine use over the last three decades or so. That's one question.

And the other is, what suggestions do any of you have for the OTC industry about groups we can work with to further get out messages that would specifically help the transportation industry? Because we do partner often with Food and Drug Administration, with a host of consumer groups, minority groups, senior citizen groups, et cetera. So, we'd like your suggestions.

DR. HARTENBAUM: I think the first issue is that we're dealing with a different population. I had not heard of the second organization you mentioned. I'm aware of OTC, information that's out there. It recommends don't operate machinery, don't drive until you know how this affects you. The problem is, is the individual has that choice. I can say, "Okay. I have a cold. I'm not going to go drive today or I'm going to drive from here to the supermarket."

With commercial drivers, we're dealing with those who need to show up at work or they're going to get disciplined or they're going to lose their pay or are driving 10 hours, according to our service regulations. So, the amount of driving they'll do is different.

The information provided includes, "Be careful." And the drivers are being careful. The problem is there's difficulty in recognizing the level of impairment and in essentially multi-tasking. You can concentrate on one activity. But if you have a car coming at you from the right, another one coming from the left, and they're walking across in front of you, you may not have that reaction time to respond appropriately. And the exposure time and the potential hazards are very different from the private drivers that's into commercial driving.

As far as organizations, I can give you, "Gee, I can suggest." Probably afterwards would be --

MR. EDGELL: The -- specifically as -- since we are mainly talking about the Federal Motor Carrier Safety Administration, a good point of contact within Motor Carriers would be the Physical Requirements branch.

Also, it sounds like that just physicians in general would be an excellent place to start to provide this information since they -- they are what we are relying on -- who we are relying on for safety of -- of the drivers.

MS. RUSSELL: Thank you very much.

DR. ELLINGSTAD: Thank you. Next we'll move to the Professional Sleep group.

MR. GELULA: Thank you. I have a question first for Dr. Hartenbaum and then Dr. Parmet, and it's the same question. At this hearing yesterday the Delaware deputy attorney general cited an egregious example of a failure to adhere to established trucking hours of service rules resulting in that case in a catastrophic collision. And I'm wondering if you would explain the hours of service work rules for commercial drivers and, Dr. Parmet, for pilots and then address how such work rules would create drowsiness and sleepiness for many, if not most workers and interact with sedating medications?

DR. HARTENBAUM: Okay. They're very detailed. It's basically -- I'd might defer from -- details, but they can operate 10 hours without a rest period. And I believe they have to have eight hours -- it's 60 hours a certain number of days, 70 hours other days. There was a new hours of service rule proposed -- it's been put on kind of indefinite hold -- which was more based on giving them adequate rest areas and looking at some of the studies to see people don't rest during their time off.

MR. GELULA: But those work rules have not been implemented. The existing work rules, as you said, 10 hours on, eight hours off, and then 10 hours on and eight hours off. So, there -- isn't there a circadian effect there?

DR. HARTENBAUM: Absolutely. There's a maximum number of hours you can put in over a seven-day period. But getting yourself regular sleep when it's required is definitely a problem.

MR. GELULA: How would that react -- relate to sedating medication?

DR. HARTENBAUM: Certainly not helping.

MR. GELULA: And -- and for pilots, could you also explain, Dr. Parmet, the distinction between flying time and duty time?

DR. PARMET: We clock them in when they -- they actually push back, so that's when their flight time begins. They do have an 80-hour work month. But they may put in 160 hours to get their 80 hours because they're going to show up, report for duty, and brief their flight, pre-flight the aircraft. If there's a delay there's going to be more -- more time before they actually push back and start the clock. They will have a limited duty day and we forecast a particular flight -- run a flight crew out we have to put a second crew on board the aircraft so that one crew takes off and the other crew lands. They have mandatory rest periods.

We work very hard in the commercial industry to make sure where people are staying is adequate, quiet so they do get good rest. We -- hotels to make sure that we get our -- our people appropriate rest.

In the air taxi operations, however, the rules are considerably looser and you'll find that somebody's -- may put in two or three hours in the morning and then be back in the afternoon and put in three or four more hours the same day. Certainly, there's -- teeing is an issue here.

Circadian synchrony, or jet lag some people call it, is -- is a major problem because when we're trying to have someone operate when their body clock says sleep, your performance goes down. And as I mentioned earlier, that can be the same as having several drinks of alcohol. When you add any sedation whatsoever to that from a medication, even one that someone is well adapted to, as we mentioned, -- which people typically don't have sedation after a week or two on that medication. Put them into a situation where they're fatigued because of duty time, working, and they're out of their daily body synchrony, now you have a synergistic effect and it all adds up to create an unsafe situation.

We try by scheduling to avoid that in commercial airlines. We work pretty hard -- we're not there yet -- working -- our pilots' unions are trying to make sure we work on it.

MR. DROBNICH: One quick question. You did a pretty good job of covering all the different modes but what I didn't hear a lot about was light rail and bus operators, which concerns me very greatly. Can you describe any educational efforts aimed at transit operators or are they covered by any rules or regulations from Department of Transportation?

DR. HARTENBAUM: Light rail are generally covered under the FRA, so they'd be under those regulations.

The buses are often CDL holders and will fall under the FMCSA standards. The ones that are not covered of the FTA are the subway operators. And it really -- I noted the FTA has put out both a -- has a newsletter that goes out to the examiners and several companies have gotten together and they do have questionnaires that are sent to the employees asking them to fill out by the treating physician, "Are you safe or are you not safe?" So, we're kind of back to the same question as before.

MR. DROBNICH: Does the FTA have any rules or regulations covering Metro rail drivers or bus operators?

DR. HARTENBAUM: Rail and -- under highway. The -- there was a letter issued -- you know, I have the least knowledge about FTA or FAA. There was a letter issued by the secretary about two years ago reminding transit companies that they need to educate their operators. I do believe that most of them have now standardized the form and do educate their operators.

MR. DROBNICH: Is the panel aware of any educational efforts towards transit operators on this issue?

MR. EDGELL: Transit has over the past two years run a number of training operations on fatigue classes, substance abuse classes, drug and alcohol seminars. And they've continued to plan for those in the future as well. And Doctor's correct that transit is very much influenced by the rail industry or the motor carrier industry because of the obvious association -- your large transit operators, say, in total are very aware of the medication issues, as I mentioned before, and have those in -- in driving training orientations.

DR. ELLINGSTAD: Thank you. We'll go to the Government group. Mr. Clarke?

MR. CLARKE: If I can -- let me just clarify on that last point before I get into my questions. The FTA does not have statutory authority to issue safety regulations for the transit authority. What they do have statutory authority for is to require that transit authorities as a condition of -- of being funded by FTA for capital programs have safety programs in place. But our authority to approve or disapprove those plans is tenuous, and so I think the answer to the question, "Do we have direct control over -- over transit operations," we at the Federal level, the answer is "no." But we certainly work very closely with transit operators to help them do the right thing. And I think the point that's being made here is that they are conscientious and responsible.

MR. DROBNICH: Just to follow up on that, has the FTA given guidance in this area to the transit authority?

MR. CLARKE: Well, I think Mr. Edgell pointed out that there's been a series of classes and training exercises done in which this is part -- this issue is part of that subject.

Let me go on to some of my questions. Dr. Hartenbaum, there was some back and forth earlier on about FMCSA's role in -- in your -- and ACOM's activities in training. Can you explain further whether or not -- it's my understanding that they have had some more than small amount of involvement and cooperation with you folks on that work, is that -- is that not true? In terms of guidance or support or coordination?

DR. HARTENBAUM: No.

MR. CLARKE: No? You've had no contact with them at all?

DR. HARTENBAUM: No. We've had contact. We've actually had much more earlier on where we did have someone from FMCSA speak one of the lectures -- two of the lectures much earlier. We actually asked -- we discussed the possibility of working more closely and were kind of told that the agency couldn't sanction one training program over another. We also have a newsletter that's put out through ACOM which we have -- I sent an open invitation to the FMCSA and also the NTSB to submit articles. And you know, they've had the time to answer specific questions when they've been posed.

But no, the -- is not overseeing it, it is not reviewed, it is not sanctioned by the FMCSA. The information we present is primarily from their regulations and their conference reports although the conference reports are many years old.

MR. CLARKE: Are you familiar with FMCSA's waiver program for disability folks?

DR. HARTENBAUM: Well, there's the skill forms evaluation certificate, which used to be -- orthopedic waiver program. And yes, I also am aware of what used to be the waiver program for vision and diabetes. It was then changed after being challenged to an exemption program. I know there was a "Federal Register" announcement about two or three, maybe six months ago concerning the option of exempting insulin-requiring diabetics. I believe at this time there's only exemption or waiver programs that are under consideration.

MR. CLARKE: And there's a testing program associated with that, too, is that --

DR. HARTENBAUM: The only testing program is for the skill performance evaluation certificate, former orthopedic, requires a road test.

MR. CLARKE: Is it your -- is it your sense that that's an involved process?

DR. HARTENBAUM: Yeah, that is an involved process. The processing of the vision waiver, which is the only waiver currently being -- vision exemption. The wording was changed in 1998 -- required an ophthalmologist to say the person is safe and that their vision hasn't changed.

MR. CLARKE: Does this go before some kind of board or --

DR. HARTENBAUM: It's published in the "Federal Register." There is a required public comment period for this exemption.

MR. CLARKE: Would you see the same kind of thing evolving if this was to expand to kind of -- in fact, he was talking about here. In other words, folks looking for waivers and --

DR. HARTENBAUM: I think the program could exist and would be very well -- well based if there was a decent review mechanism in place. Unfortunately, the individual who's saying that he is safe is the person's treating physician.

MR. CLARKE: Right.

DR. HARTENBAUM: The waiver program in the FAA has individuals who are trained and understand flight. They understand the medical conditions that occur in flight. Right now what the FMCSA does for their waiver programs is they put it back to the treating provider. You know, I've --

MR. CLARKE: But still, I'm talking procedural. What -- what is -- what is the process involved in attempting to get one of these things in terms of due process and -- and amount of time spent to do all this?

DR. HARTENBAUM: There's two different pieces. First is the orthopedic piece where the motor carrier or the individual can submit to a state or regional director of the FMCSA that they're, first of all, otherwise medically qualified, what their orthopedic limitation is, how long they've had, what kind of vehicle they're operating, how long, and all the details that go along with that. They then undergo a road test.

MR. CLARKE: So it's an involved process?

DR. HARTENBAUM: That's an involved process. The other waiver program or exception program is vision and there they submit an application to the Federal agency, who gathers information including their safety record, and gets information from an ophthalmologist about their vision, about whether it's stable or not.

MR. CLARKE: Any sense as to how many folks total might be involved in both these, then?

DR. HARTENBAUM: Yeah. There's probably about 400 in vision exemption right now and -- better number on that. There are also a number, probably about 1500 who have been in the original waiver program for vision and I think about 200 may still be floating out there who have been in the insulin --

MR. CLARKE: Would you like to venture a guess as to how that process might work? Because the number was 3 million or 4 million or so.

DR. HARTENBAUM: I think at --

MR. CLARKE: Attempting to get those kinds of waivers.

DR. HARTENBAUM: I think it would be overwhelmed, the system. But I think that even the way it works right now I have concern about, you know, there's -- put the information out. On one hand, there's a report that just came out sponsored by the -- the FHWI that the vision requirement is necessary and in fact to recommend that the field of vision be expanded to include a vertical requirement, not just a horizontal field of vision as it now exists. Yet, we're -- they're granting exemptions --

MR. CLARKE: I guess my question goes to the process, not the -- not the criteria.

DR. HARTENBAUM: The process -- I think there needs to be a better medical body that reviews this than just the person -- personal physician.

MR. CLARKE: But -- but in your opinion, how would that work if the numbers were on the order of millions?

DR. HARTENBAUM: It wouldn't work.

MR. CLARKE: So, how would you -- how would you suggest, then, if something like that --

DR. HARTENBAUM: I think you would need a system similar to the FAA where there is a group that is dedicated to looking at the waivers and has sufficient staffing and funding --

MR. CLARKE: And how many --

DR. HARTENBAUM: -- and expertise.

MR. CLARKE: -- how many folks do you think that would take?

DR. HARTENBAUM: I couldn't begin to --

MR. CLARKE: Do you want to guess?

DR. HARTENBAUM: How many does the FAA use? Multiply it by a factor of --

DR. PARMET: Well, --

DR. HARTENBAUM: -- 10.

DR. PARMET: -- right -- right now I think the FAA has about six full-time physicians. Is that right, Doctor -- down at -- down at CAMI who review 7000 field examiners. You would probably need some --

MR. CLARKE: And that's for a population of how many -- how many --

DR. PARMET: We -- we have around 600,000 pilots.

MR. CLARKE: How many commercial?

DR. PARMET: Commercial, I think it's around 150,000. I'm -- it's in that area.

MR. CLARKE: So, we're talking a population of 100-, 150,000 commercial operators?

DR. PARMET: Right. You would have to proportionally be on the same ratio. If you have enough people, your process will work properly. But that's what it requires, enough people to properly access, review, and analyze each individual case.

MR. CLARKE: So, we're talking hundreds of thousands of -- of field examiners, the equivalents of AMEs --

DR. PARMET: Right -- right now you have no clue as to how many examiners you have. It's theoretically every licensed exam --

MR. CLARKE: Physician.

DR. PARMET: -- P.A. in several states. You know, you're talking millions. You have no idea who --who's out there.

MR. CLARKE: No, but I mean in the system --

DR. PARMET: And no idea --

MR. CLARKE: -- in the system that's been suggested here, do you want to hazard a guess as to what the scope might be as it relates to the commercial driving population?

DR. PARMET: It -- it would be proportionately large. You'd probably need around 100,000 examiners.

MR. CLARKE: Or more.

DR. PARMET: It's -- possibly, yeah. It's -- it's doable.

MR. CLARKE: And a review mechanism associated with reviewing what -- what those --

DR. PARMET: That -- that's right. You'd have to meet proportionally that kind of training system set up to do it. But you could do it. It's not impossible.

MR. CLARKE: No, no. I'm not suggesting it's impossible.

DR. PARMET: Been working for the FAA since 1926.

MR. CLARKE: Are you suggesting, then, that -- that you think in -- in -- in your opinion that some system like that -- of that magnitude is -- is -- is practical and warranted?

DR. PARMET: I -- I think it's warranted. I think it would be practical. It's -- if you do it computer-based, which is how we do it with the FAA, 99 percent of the routine physicals are absolutely standard and they're reviewed on a computer base compared to published regulations. And you know the person meets the standard. When they don't, then they require review.

DR. HARTENBAUM: One comment on published standards. The published standards for pilots is much more detailed than for highway. The cardiac one for -- for highway states that they can't have cardiac insufficiency -- I forget the exact wording right now. I should know that -- or any other medical condition likely to result in loss of consciousness, syncope, or congestive heart failure. But it doesn't give guidance as the FAA's does on how long they need to be -- after an MI, what's required after a heart attack, whether they can have a pacemaker or not, what kind of -- they can have. So, the specifics --

MR. CLARKE: As a --

DR. HARTENBAUM: -- of the regulations are very different.

MR. CLARKE: -- as a practical matter, all of that, if it were to be done, would have to be done in a rule-making process.

DR. HARTENBAUM: That would be correct.

MR. CLARKE: And -- and all of it would have to be subject to the scrutiny of -- of the rule-making process in excruciating detail on every aspect of every guideline.

Is it -- do you have any sense as to whether or not the new Motor Carrier form has helped at all in terms of highlight -- or heightening doctors' awareness of the need to be sensitive to this issue?

DR. HARTENBAUM: The issue in general or just sedating medications?

MR. CLARKE: Medication.

DR. HARTENBAUM: I think it has made them more aware, those that read it. We know a lot of them don't read it, especially the ones who do one or two a year. They are instructed to discuss with the driver. But even just discussing it doesn't always solve the problem because the drivers don't understand how much impairment they may have and the treating providers don't understand.

MR. CLARKE: So, in your --

DR. HARTENBAUM: I think there's improvement. Do I think it solved the problem? No.

MR. CLARKE: But there has been improvement?

DR. HARTENBAUM: Some.

MR. CLARKE: Thank you.

DR. ELLINGSTAD: And finally, we turn to the Evidence group.

MS. TARNEY: Two questions for Mr. Edgell. What do you know about training of pharmacists and physicians during their professional schooling, if any, on the issues of driving and medications?

MR. EDGELL: I really can't comment on that at all. I have very limited knowledge. Physicians might be better to address that question.

DR. HARTENBAUM: I'll handle that one. Not very much at all. I gave -- rounds at a hospital recently. Not even looking at commercial drivers but just reminding them that there are medical standards for private drivers and a significant physician -- significant proportion of practicing physicians weren't even aware that there were medical standards for private drivers. They weren't aware that -- I live in Pennsylvania -- that Pennsylvania has a mandatory reporting law. So, these are practicing physicians.

In private -- in medical schools they're not taught at all.

MS. TARNEY: Is the DOT working with the AMA,the American Medical Association, for general physician education?

MR. EDGELL: Specifically, I'm not -- I -- once again, I'm not able to comment on that specifically.

MS. TARNEY: We have two questions for Dr. Hartenbaum. Along with your talking about generating a -- you'd like to see a list of -- of drugs generated that are absolutely on a unsafe list, would it also make sense to you to have your examiners trained on the issue of impairment and not rely totally on medications so that variations can be included -- individual variations can be included?

DR. HARTENBAUM: I would love to see examiners properly trained on impairment, on medical conditions, on prognosis, on understanding that if a person has a small heart attack they're not necessarily safe to go back to work one week later because that small heart attack may extend out, become a large heart attack. So, there's a lot of education that needs to be done.

But what's important is we need to have support -- companies and the examiners need support to make a decision and not constantly be challenged, as we're seeing right now.

MS. TARNEY: In the courts?

DR. HARTENBAUM: Yes.

MS. TARNEY: Another question for Dr. Hartenbaum. Are you aware that the Australian truck drivers operate without any limiting hours of service and that surveys have shown that up to 25 percent of them use amphetamines to stay alert and to keep driving? Could you describe some of the psychomotor degradation and cognitive impairment that can result when drivers operate trucks for very long consecutive hours and are actively using drugs to stay awake?

DR. HARTENBAUM: No.

(Laughter)

DR. HARTENBAUM: It's not a good combination, but I am not a psychopharmacologist. So, I -- I was aware that Australia did not have hours of service regulations. I was not aware that that many of them operate with enhancing medications.

MS. TARNEY: Do you think there's that many in -- in this country? I hear rumors all the time that there's that many and more using amphetamines.

DR. HARTENBAUM: There may be. We have run into a problem where providers will prescribe ritalin for drivers who have, quote, "ADD" to help them stay alert while they're driving. You know, we do have to talk about the underlying condition, if they truly have ADD. Again, there's medical -- medical literature out there that drive -- individuals with ADD don't drive safely. However, the physicians swear that they're safer because they're on the amphetamine.

So, you know, it's really the information and getting it out there and having support to make these decisions.

MS. TARNEY: Thank you.

DR. ELLINGSTAD: Thank you.

I believe we have a couple of questions from the audience. Dr. Galson?

DR. GALSON: Let me just start with a question of my own. In the air transport sector, how are sedating antihistamines treated with regard to their stature on these lists?

DR. PARMET: All sedating antihistamines are not --

DR. GALSON: If some --

DR. PARMET: -- are not -- sedating antihistamines are not approved. The so-called "non-sedating antihistamines" must go through a trial period and then we can submit the individuals for approval to be chronically on them, keeping in mind that about six percent of people are sedated by the -- the non-sedators because they don't have the enzyme in the brain that actually pumps the -- the drug back out.

DR. GALSON: Great. Okay. From the audience, if medical examiners will be required to be certified, what would be the impact on the number of medical examiners that would be willing to continue conducting exams? This is for anyone on the panel.

DR. HARTENBAUM: Well, I think that's been a concern all along is that the number of examiners will go down. I think we're now seeing with the medical review officers as they're now required to be trained and pass an exam that the numbers will drop off. So, I think the -- the number will go down. There also is concern that as the number goes down, the cost may go up both because of the cost of training and the decreased access, supply and demand economics.

DR. PARMET: When we did the pilot program in Missouri we had a whole lot of -- that's a technical term, "whole lot" -- of -- of educational programs to certify people. We went all around the state and made it as convenient as we could. We maybe had a drop-off at 20 percent of folks but there was no increase in cost because we went out of our way to make sure that everybody who wanted to take the training could go through it.

Yeah, there would be an impact but that's -- that's the effect of every regulation we do. We have to -- have to weigh the -- the cost of the benefit.

DR. GALSON: Okay. This is a -- specifically for Dr. Parmet. If -- if a pilot flies with a company without a treating medical -- and is prescribed a medication not recommended for flight, what mechanism is there for forcing the individual to report to his AME or company or FAA?

DR. PARMET: Well, the individual's required by Federal Air Regulations to report that. And the treating -- if the treating physician's in the AME, then the AME knows that that has to be reported. But just like with drivers or any other agency, if the treating physician is not the medical examiner they may not report it. They may not even know. So, we -- we, as everybody else, have to rely on the individual pilot or driver to report and basically ground themselves in those situations.

DR. GALSON: And the follow-up to that, isn't it true that many of these drug uses are never reported?

DR. PARMET: Absolutely.

DR. GALSON: And then the last one, isn't it true that this reporting is largely voluntary? And I think you've already answered that.

DR. PARMET: That's correct.

DR. GALSON: That's it.

DR. ELLINGSTAD: Okay. I think we have a couple more from the Technical Panel. Dr. Garber?

DR. GARBER: Yeah. Just one -- one distinction that I'd like to draw would be the -- we spent a fair amount of time discussing certification of examiners or -- or examiner systems. And obviously, that could conceivably play an important role in regulating medication use by operators, particularly for chronic conditions. But I do want to draw a distinction. What about for the acute conditions? The -- many of our drivers, many of our pilots will be using, say, a benzoanasapine as prescribed for muscle relaxant properties or other central nervous system acting medications for that. For an intermittent problem that they may have they may be using the over-the-counter substances for intermittent problems that they have.

Even if you do have a -- a -- a large systematic program by which an individual has intermittent contact with aviation medical examiners or other certifying officials, how do you get to that issue? How do you get to the issue of the intermittent use of various medications, hypnotics for sleep aids, variety of different things that we -- that we commonly see prescribed and commonly see used by -- by people out in the community that would not be listed as a medication that they were currently using?

DR. HARTENBAUM: One way of doing that, the FAA's pamphlet, informational booklets that are given to AMEs to give to their pilots. Having something similar prepared to be given to commercial drivers. Just kind of a little bit of an education piece. Will it stop them all the time? No. Will it at least make them stop and think? Yes.

DR. PARMET: With regard to the individual practitioners, we're talking about every single licensed provider in the country and how do you get that information to them? One might have to actually change the labeling within the "Physician's Desk Reference," which is probably on every provider's desk in the country since it's provided to us for free. That's -- that's the best way I -- I buy that book.

But if it actually had a label on each drug that says, "This may not be used by a commercial pilot without approval by the FAA," "This should not be operated in commercial vehicles," kind of a labeling issue on that end. That brings awareness to the individual providers who may not even know that their -- their patient happens to operate hazardous equipment.

DR. GARBER: And -- and one -- one question related. For the medical certification system, we've been discussing either an FAA-type system or a system in which, essentially, every licensed practitioner can -- can allow or certify operator. Presumably, there are variations in between these two systems. And I thought I heard Dr. Parmet discuss a system in Missouri which was somewhere in between and did or did not have Federal funds or Federal requirements attached to that? Perhaps you could elucidate a little bit more on how that worked and whether that sort of system might be useful in conveying medical information -- medication information to operators?

DR. PARMET: That -- that was a pilot program under the aegis of DOT. So, the state was educating every physician. In Missouri it's only physicians and nurse practitioners can complete the DOT form for drivers. And that was just a pilot program under one year.

And we -- we actually modeled it on the FAA system using a new form that required the driver to fill out everything they were taking, including medications, and then sign it under penalty, which didn't exist in the regular commercial driver's market.

DR. GARBER: If -- would -- in your opinion, would the system that was initiated as a pilot program in Missouri at that time be as unwieldy for handling as many commercial drivers as the system that would be proposed that would be a Federally centralized system from the -- from the -- from a FAA-type perspective?

DR. PARMET: I think it has the same issues because it had to be managed at the state level. And the state Department of Transportation was having the same issues with -- with manpower as well as trying to be consistent. And you've got every jurisdiction in the country.

So, I'm not sure you would get uniformity at -- at the state level. Certainly don't have it now. It would certainly improve the system in terms of education, and drugs and sedation were addressed in that program.

DR. HARTENBAUM: With the negotiation of that rule-making committee, one of the concepts was to make a system not quite as unwieldy as the FAA system where all the information is, first of all, updated and, secondly, sent to all examiners that you're not on the approved examiner list, you just don't do it. And I would also provide a mechanism that when there's new drug information available that could be sent to the examiners and then relayed to the drivers when they show up at their exams. Kind of a cross breed between the way it is and the way FAA has it.

DR. PARMET: I'm not sure the FAA system is unwieldy, but it's -- it's more structured. It does respond. When we have a problem we get good response out of it, so I -- I wouldn't say they're unwieldy. They're a highly structured system and it's been in place for over 75 years, so it knows what it's doing. And our -- our regulations are -- that we operate under are straightforward. I've got three pages of guidance for cardiac conditions, not three sentences.

DR. GARBER: Thank you. And I believe Dr. Sweeney has a question as well.

DR. SWEENEY: Earlier the question was asked about the feasibility of a "DOT-prohibited" label. What about the alternative of a "DOT-approved" label? Your opinions on that?

DR. HARTENBAUM: That would probably work just as well. Yeah, then you would address what do you do about medications that are not on that list? There would need to be a mechanism to review those as they come along.

MR. EDGELL: I think any list would certainly be a formidable task. The review, the development, the updating. Certainly a formidable task.

DR. GALSON: But it exists already for the FAA and the military has a list, so what -- why is that such a large endeavor?

MR. EDGELL: I was not here yesterday so I did not hear the military list and I think even when you were talking about it a moment ago you had some issues with it. The -- I'm -- the -- for the DOT to prepare this list.

DR. ELLINGSTAD: Mr. Clarke asked some questions about the staffing requirements to -- to hire all of these physicians and supervise them. If we're try -- if we're talking about some kind of a magnitude estimate of the task, what would it take to do that particular task of creating such lists? And I guess we probably should have asked our Air Force and Navy folks in terms of what their investment was. Do you have something to suggest in terms of -- of how big that -- that project would be?

DR. HARTENBAUM: First you start with what exists. You take the military list, you take the FAA not officially sanctioned list. You review it, you add to it, it -- that probably is somewhat more workable than the whole certification and review process for everything else. So, I think it's workable.

DR. TILTON: I have a comment that there is no FAA list, so I --

DR. ELLINGSTAD: Excuse me. Please identify yourself?

DR. TILTON: I'm Dr. Tilton. I'm the Deputy Federal Air Surgeon.

There is no FAA list, and -- and Dr. Parmet said there's an unsanctioned list which I -- I would say is a very loose definition because what I think he's talking about is the fact that we don't allow hypnotics and we don't allow a lot of categories of things. But there's no list of medications that we have either written or unwritten or sanctioned. So, I just want to make sure that we understand there is no list, and I agree with what Dr. -- Mr. Edgell said about the -- the difficulty of developing that list, number one, maintaining it, number two, and also, coming back to what we're really concerned about, is the underlying condition.

If you had an approved list, someone might say, "Okay. I can take Medication X," when in fact they shouldn't be taking Medication X because of the side effects they might have, number one, and also because the underlying condition they have, number two, would preclude them from safely operating whatever vehicle it is they're operating.

DR. PARMET: I think you do have a list you use with your air traffic control unit, which is not quite the same thing.

DR. TILTON: Well, I guess if we do I'm not aware of it, so. The air traffic control process is managed and -- and we actually, in my mind, we don't have an approved sanctioned list for air traffic controllers as well. But we would include them in the same way we would include pilots, which would be they're effectively controlling airplanes. And so, the list of kinds of things that we would prevent them from working with would be the same things: hypnotics and anything that would sedate and anything that would be psychoactive.

DR. ELLINGSTAD: Did you have another comment, Dr. Hartenbaum?

DR. HARTENBAUM: If we could get a -- even a list like that that was official in commercial drivers that we take out of the recommendations from the conference report and say, "These are officially recommended as not to be used without detailed review," it would help the examiner because a lot of them don't even know what to do with that list. They -- 10 years old.

DR. ELLINGSTAD: Thank you. Are there any --

MR. CLARKE: Can I make a comment? Can I make a comment, Doctor?

DR. ELLINGSTAD: Okay.

MR. CLARKE: There's been a lot of discussion about recommending and requiring, and just to clarify, in the context of -- of sanctioned programs, regulated programs like pilots and locomotive engineers and so forth there are no such things as recommendations. You either have a rule or you don't. You can -- and I learned this long ago from my lawyers, that if you want to put out a recommendation, they would say, put out a rule.

So, I think we have to be clear that -- that you can't deal with recommendations here in the context of official DOT-recommended lists. It's either a rule that would allow or prohibit or not. And therefore, I think we -- we have to be mindful of what all that entails to get such an official prohibition or approval in place. I think that's some of the distinctions that we're trying to draw here. Recommendations, trade associations, professional societies, the AME, for example, can make all kinds of recommendations about best practices and -- and professionally recommended ways of doing things, but officially sanctioned and prohibiting is a very different issue.

DR. GALSON: Just --

DR. HARTENBAUM: I --

DR. GALSON: -- just a quick comment. Sorry.

The Food and Drug Administration and I believe lots of other Federal regulatory agencies make recommendations that don't have the weight of law. So, there are officially sanctioned guidances or recommendations that the Federal regulatory agencies make. They wouldn't have the force of prohibiting but they can be used as guidances by industry and other groups, and that's fairly common Federal regulatory practice.

DR. HARTENBAUM: The conference reports I refer to are -- were sponsored by the FHWA and it does say, "These are not officially sanctioned recommendations." But they are what the medical examiner tries to use to give some guidance to these very vague regulatory pieces. And because they're only recommendations from a conference that hasn't been sanctioned, they really don't carry any weight and that is very frustrating.

MR. CLARKE: Right. But that goes to the next step you talked about: people then looking for official ability to go back to work or not go back to work or prohibiting people from going to work.

DR. HARTENBAUM: The examiner's looking for guidance, whatever way we can get it. And the -- the guidance from the conference reports are many years old. And anyone who tries to stand behind them and say, "This is what the recommendations from this group of specialists -- representatives suggest we do" are challenged. So, the examiners try to follow it but are really given a hard time.

DR. ELLINGSTAD: Okay. Anything else from the Tech Panel?

(No response)

DR. ELLINGSTAD: Okay. I'd like to thank the panel very much. Any effort here that keeps Todd awake all morning is -- is --

(Laughter)

DR. ELLINGSTAD: -- certainly worthwhile.

We will reconvene at 10:30 for our International Panel.

(Brief recess)

Witness Panel VI - International

DR. GALSON: Let's get started. Like to start with our sixth panel here, International, and give a special thanks to this crew that has traveled tremendously long distances to come give us the benefit of their expertise and input.

The first speaker is going to be Jennifer Bergin, who is a pharmacist consultant at the Pharmacy Guild of Australia. Thank you.

MS. BERGIN: Dr. Galson, Dr. Ellingstad, members of the panel, thank you very much for inviting me here.

(Slide)

MS. BERGIN: What I'm going to do today is give you an overview of -- overview of the professional and regulatory partnership that exists in Australia.

(Slide)

MS. BERGIN: Okay. Just by way of background, the -- approximately 25 percent of drivers -- of the 3400 drivers killed in Australia in road accidents -- yesterday one of the other speakers referred to Olaf Drummer's work. We -- we have evidence that shows that -- goodness. 25 percent have drugs in their system and of those people, 15 percent had cannabis, 13.4 had psychotropics, 4 to 4.4 percent had opiates, 3.8 percent had stimulants, 3.6 percent had benzodiazepines, and about 8 percent had both drug and alcohol in their system.

It's interesting to note that most cyclists had a higher instance of cannabis, some 17 to 20 percent, and as already mentioned this morning, truck drivers had -- had an incidence of 20 percent of stimulants. These -- these figures are similarly demonstrated in the seriously injured category.

And also, we have a -- a regulatory system that involves subsidizing medicines called "Pharmaceutical Benefit Scheme." And that largely determines how frequently a drug is prescribed because it is subsidized. And of the 250 frequently prescribed drugs, 25 percent are either known or suspected of being capable of impairing users' driver skills. And we have 120 drugs that are actually -- that actually require sedative warnings.

(Slide)

MS. BERGIN: The regulatory framework includes two main categories. The "Prescription Only" system is governed by therapeutic goods orders under the regulations and they require warning statements. As I said earlier, in the standard for the uniform scheduling of drugs and poisons there's an appendix with 120 drugs and pharmacists are required by law to label these with sedative warnings.

(Slide)

MS. BERGIN: In the Non-Prescription area we have two categories of drugs: Schedule 2 and Schedule 3. The -- these are known as "Pharmacist Only" medicines or "Pharmacy" medicines. In this category as a -- as a restriction to the licensing or the registration of the product the manufacturer has to include the warning statements on the packaging.

(Slide)

MS. BERGIN: In the Professional Framework we have a publication called the "Australian Pharmaceutical Formulary Handbook," commonly known as the "APF." In that book the counseling notes.

(Slide)

MS. BERGIN: There are 153 drugs that are listed as an instruction to pharmacists as to what -- what additional information to add to the counseling and also dispensing process.

So, if you can on that slide, there are lots of numbers and letters, and so something with a Warning 1 or a Warning 12 would indicate to the pharmacist that a stated warning statement would be required. We will go back to that in a minute.

These take the -- these take the -- SUSDP, the standard warning statements, of which there are three, a little further because they add drugs like antihypertensives and hypoglemics, drugs that may cause dizziness and lightheadedness or -- particularly in the early part of dosing or where the doses change, the pharmacists would use their discretion and add those -- add those -- not, no -- sorry. Not discretion. They would add the warning segment but they would also discuss with the person what would be the most appropriate label for -- depending on the person's intended use.

(Slide)

MS. BERGIN: The other link is that the -- the warning statements that are in the -- that are in the regulatory framework have been taken up by companies who produce these -- these -- these three stickers. Now, they don't quite match the warning state