Determine it for you directly in the home. There so many dozens of different masks and full face masks for mouth breathers and let you sleep on your side or back. Its a flow generator and with an open airway its possible to have a continuous flow of oxygen and with oxygen the patients can sleep and get a break from all that adrenaline. We know with randomized trials, they show c pap lowers crash risk and creates alertness and a driving simulator can improve in as little as two to seven days. People feel better. Their Blood Pressure is lower and heard disease and stroke risk and even mortality all improve and we know that they spend less monohealth care. There other therapies including oral appliances and surgeries. The body of evidence that supports the use is so enormous that that tends to be the first line therapy. We also recommend that the patients lose weight and they limit alcohol and sleeping pills and narcotics to the lowest amount they can get away with. Avoid tobacco smoke that can increase the swelling and make the airway more collapsible. And also to keep the nasal passages open by controlling nasal congestion. n if they need surgery, we will advise to correct the deviated septum. We can monitor those using the c pap. Not only the ds cards, but they have modems that snap on to the back of the machine that allows us to track tonight how many hours they use it. What was the pressure level and is there still apnea going on and was the mask leaking . We can address the issues as we go. This is an example of such a download and the green color indicate that is the person use it for at least four nights. Night after night and on the fifth night they skipped it and it was blank. In summary, i would say that the sleep apnea is common. Its definitely been linked to sleepiness and crashes as well as Major EconomicHealth Outcomes and importantly it can be diagnosed in the home. The treatment is inexpensive and inaccessible and shown to lower trash risk and improves many conditions and can be tracked in realtime. Thank you. Thank you very much. Our final panelist is from the food and drug administration. Im a clin dal team leader in the center for drug evaluation and research at the food and drug administration. I would like to thank the ntsb for inviting them here to talk and im going to start with a slide that said the views i am going to express are mine and not necessarily of the fda. One of the discussion questions that will come up soon is what the fda is saying to patients to help them understand the risks from drugs as with regard to drowsiness and driving. In this presentation there, its hard to see, but there is yellow. On my screen its hard to see. Yellow highlights around text and that text is from web pages that the fda has that help patients to understand risk from drugs and also the picture on the right is from a pamphlet available to patients who would like to learn more about the effects of drugs on driving. So the fda is trying to communicate clearly the risks that can occur from overthecounter drugs and to use clear language and make clear recommendations like you see here fda and actually working with the ntsb and other sister agencies that warns patients that both prescription and over t kountthecounter medications can make it to drive. One important way that the fda judges the acceptability of risk of drugs, all drugs have risks but whats an acceptable risk . We looked to examples like Drowsy Driving or examples like drunk driving. Driving under the influence of alcohol. To try to understand societys tolerance for risks from drugs and one of the things we look at is the legal definition. Not to give legal advice but to warn patients about if you take this particular drug, would you be impaired to the same degree that you might be from alcohol at the legal limit for driving . I think too that normally when you think of adverse events from drugs, you think about injury to your liver or skin reactions. That kind of thing. Certainly crashes are a serious adverse event and even the whole even if its not illegal, being stopped by the police is something that patients would be interested in avoiding. So the car crashes are right in the middle of frequent events and rare events. So that if you give somebody a drug and they get into a car crash, they are frequent enough so you cant say necessarily that the drug caused the car crash and rare enough that if you do a normal sized trial of an experimental drug, you only see a few car crashes and not the power to determine if the drug increased the risk of the car crash. The studies could be designed and designed to investigate the increased risk of the car crash from the drug, but they have to be large and most of the time thats not practical. If you have suspicion that they would cause car crashes, it would be problematic to expose them to that risk. Looking to examples from alcohol and from Drowsy Driving one approach that we have been looking the fda is the effect that drugs have on driving skills. This is very helpful. Drugs are certainly complicated, but drugs are extremely complicated, a drug for insomnia when the blood level is high, its dangerous to drive. How many hours after taking the drug would it be to drive again . Some of these kinds of detailed questions about drug levels that are individual patient variability is much easier in a controlled trial and laughboratory with a simulated car. So this again is an image from the fda website and stressing that knowing how your medications and any combination of them affect your ability to drive is a safety measure that involves the patient and their passengers and others on the road. In fact, the sign here, the traffic sign shows the whole list of problems that could be caused by drugs that could affect your title drive in addition sleepiness. Some of the others are more straight forward. In terms of the patient perceiving the problem like fainting. One of the things that has been talked about are patients are unaware of the drowsiness and other affects on their thinking. So that its less reliable to judge the ability to drive after you have taken the medicine based on if you feel awake and alert. There is a tremendous complexity to trying to understand the effects of drugs that are mixed together. Its difficult to understand the effects of drugs in different people who have different blood levels after taking the same dose who eliminate at different rates. One thing the patients need to be aware of is the combinations of drugs like two drugs have caused sleepiness can have a far greater effect than taking one drug alone. There is a very large number of drugs that cause sleepiness and they increase that risk in controlled trials and we often see things like 10 of patients who take the drug are sleepy during the day versus 3 of the people on placebo. Its a randomized sample and they have the same disease. We know about that increased risk and this is represented in the label for drugs. The website for the fda gives kind of a long list of categories and we would recommend people check with their Health Care Provider and with the pharmacist can read the drug labels and information that comes with the drugs. This list shows how a very large variety of drugs can cause anxiety and antidepressants and drugs containing codeine and narcotics. Cold remedies and allergy products and sleeping pills. At the bottom it lists diet pills. One thing we are concerned about is there is the possibility of the increased risk of crashes from sleepiness but drugs might affect a persons judgment. Even if they are awake that could lead to problems with Decision Making or aggressive driving, if you will. Thats one character in stimulants that we are interested in evaluating. When thinking about what should be assessed, this line here said safety concerns could differ based on the drug and safety population. Really to say it most clearly that is that the drugs have different effects on different people. Right now i think doctors and the fda are struggling with how to identify patients from a particular drug. Thats the ideal place to look. A lot of patients can take a drug safely and some are at risk and the goal to be to try to identify the patients who are sleepy from the drug. We have taken a lot of guidance from work done by ntsb and meetings and expert panels and i apologize that this is small but its kind of a graeme work for the fda that we have been using to evaluate drugs. Up in the left hand corner the basic pharmocology of drugs and what receptor are they binding to and what neurotransmitter are they affecting and they give a strong indication if a drug will be appearing. We have a drug often used for sleep or anxiety. They those generally cause a great deal of sleepiness. Then off to the right there is epidemiological evidence. There is evidence that drugs that can make people sleepy do increase the risk of traffic accidents. And then down at the bottom is this focus on standardized studies. Taking a look at neuropsychological tests and measuring alertness and arousal and going through actually all of the important brain functions. That brain functions are important for driving. Arousal and sleepiness is important, but it would go on to things like executive function. In the setting of studies for drugs, again we can ask Drug Developers to enroll patients or Healthy Volunteers and do randomized trials and have positive controls and have a really good idea of skills important for driving like being able to stay within the lane of the highway. So at this point i think we are changing to a more sophisticated drug. We were collecting a lot of data about patients complaining of sleepiness and representing that and the label. Now more recently we have labels here where they go into some detail about the kinds of driving studies that were done and the results. We make recommendations about the dose and as the dose increases in some of these drugs, these are involving sleep. At the highest dose we will say essentially that unless the physician and patient know that the patient is not impaired, not just that they dont feel sleepy, it may not be a good idea to drive or maybe there is another drug for that patient. Thank you. Blap. Risk mitigation, patients are not aware they are sleep fre a drug or it has effects on the judgment. If they do feel sleepy or do feel impaired they shouldnt drive. That could be paired with from the fda website, learning to know how your body reacts to the medicine. A lot of this gets back to the pharmocology. To the dose. Its effective for the condition and to making sure that for some drugs like drugs for insomnia, they take them at the beginning of the night and have a full night of sleep before you drive again so that the drug levels are low and shouldnt affect you by the time you drive in the morning. Its trying to combine how they feel with kind of a wise doping strategy to decrease the risk of Car Accidents from drugs. Thats the end. Thanks. Thank you very much, doctor fark as. This is a pretty complex issue, how to deal with the Health Issues related to sleepiness and driving. And so this is really a question that i would like to hear from each of you. The information that is currently available to patients directly to patients related to over the counter or prescription medications. Are they getting enough information to make knowledgeable decisions . Well, were increasing the amount of Information Available to patients and for example in prescription insomnia drugs, there is medication guides that go to patients and describe risks like Impaired Driving and describe how the medicine should be taken and very straight forward language. We also have Information Available to the patients that are very much saying that some drugs even overthecounter drugs can impair driving. Saying very clearly if you are going to drive you should try to select the medicine that doesnt cause sleepiness. Or trying to direct people towards safer drugs. I can tell you that in some of the patients i see, particularly at the va, they are not just taking one drug once in a while to help fall asleep. A lot are on multiple medications, all of which has sedation as a side effect and all too often they appear unaware of which cause sedation and which dont. I think that it really speaks to how fragmented the Health Care System has become with specialists doing their own thing and not necessarily being aware of the whole picture and what else is the patient dealing with and what meds are they on and the patients seem unaware too often. There is definitely room for improvement. I think in the general population, the people are knowing the major effect of the drug im sorry, can you speak into the microphone. Yeah. They are knowing the pills that are responsible for sleepiness. The usual medications that they take for medical conditions and the conditions, they know it they drive, they must diminish or stop the medication. For the people that are taking otc, for example it is show s that often they dont read the indications that are there on the medication. Also the fact that for example you can take a pill because have the fruit and inside this one is responsible for sleepiness. This is the damage. So again, i think we are highlighting the complexity of this. Is there enough have we done enough to educate and provide the correct information to patients regarding these side effects or is that in some cases still difficult for Health Care Providers to interpret . I think that there many sources of information to Health Care Providers in particular. They are tuned in to the Health Safety communications out of the fda and a lot of news over the past few years about the dangers of drugs that impair your brain function for driving. And they are really i think equipped with the information they need to advise patients about drugs that impair driving. The paint is taken that there drugs available over the counter to patients that cause sleepiness and the fda is studying patients understanding of the labeling. It is trying to figure out the best ways to communicate to patients the things we have on the website. If you are going to be driving, you should select an overthecounter medication that is less likely the cause of sleepiness. One thing that made a big difference for us as providers is having e prescribing available. The sedation is cross checked and getting the medication from the same source. Similarly these systems can also cross check for conditions that requires lower dosing and things like that. Those have helped and the question is, are we doing enough to educate our patients . I can tell you as a busy practitioner, time is of the essence. I think that we need to make more avenues available for patients to get the information. It is critically important. Pharmacists would be another great venue. I know they give an insert when patients pick up the prescriptions and i dont know who is stopping to read those inserts. If sleepiness is one of a long list of side effects with lots of percentages mixed im not sure they can be getting that they could be the that has that side effect. We have a lot of people underlining the fact that we must do more. Thank you. The next question is for the doctor. One of the interesting things that you mentioned was the relationship between psychiatric disease, sleepiness and accident risk. Do we have convincing evidence that treating that disease changes that level of sleepiness for the crash risk . We know that they can be at risk from accident. The sleepiness project out for the diseases. I think that the depression by itself is giving to the people and they are more important and responsible for a lot of accidents. Thank you. One of the things we run into in commercial transportation is a pretty big reluctance on the part of operators to even explore the possibility of whether or not it might have a sleep disorder like sleep apnea. In my personal life, i have a couple of friend who is have sleep apnea and they dont want to know. Can you talk about the folk who is may be more or less likely to be willing to be tested and treated . I will jump in there. That has been the area of my research and there certain aspects to care delivery that seem to help people come forward. Education is really important, but even if they are aware there is a condition called sleep apnea, they dont come forward because of fear of employment repercussions. Its important that its nguyen punitive. We have recommendations for how to screen from the bodies now. The Society Task Force and we have a number of guidelines and we all agree that you have to find a way to diagnose and treat people while keeping them in service. They dont feel their employment is threatened. Affordable of diagnosis and treatment and we have come a long way in recent years. With home sleep testing the cost has come down considerably and automatically adjusting positive airway pressure. In more patients, they have health insurance. I think that we can continue to improve accessibility, but that made a big dent. The third place is providing ongoing support for c pap that they dont stru as a thing that gathered dust in their closet. That has them feel better. Less so on ongoing support. That is something undergoing major transformation right now. Thats all good news for patients. You mentioned a couple of times that recently working very hard to try to increase the amount of information that is available to patients and care givers. Can you talk about where people may be able to find that information. Particularly for the overthecounter medications. We tried to have simple drug facts on the over thethecounter medication s that contain simple and straight forward easy to understand warnings that the drugs can cause drowsiness. I think the goal is to still direct patients towards drugs that dont cause drowsiness. If they are going to be driving. They have drugs that they have used for many years and to give the option for drugs that can be and effective and are not ideal to use while driving and while directing them to safer drugs if they are going to be driving or safer if you are driving. Thank you. Doctor price . Excellent presentations so far. We have one additional question to dr. Fark as. You talked about the challenges in addressing and studying driving risk through naturalistic and epidemiologic approaches. You alluded to studies as one promising approach that is being employed. You can talk about if drug testers are using the testing and what would be the role of the fda and the drugmaker in doing that type of testing . To what degree those drugs might impair the driving. The Drug Developers a