Obstructive sleep apnea affects around 20 million Americans and can lead to hypertension, heart attack, stroke, depression, muscle pain, fibromyalgia, morning headaches, and excessive daytime sleepiness.

Tuesday, July 20, 2010

FMCSA Medical Guidelines for OSA: What is right and what is wrong with these guidelines. HOW SAFE ARE TRUCKERS ON THE ROAD?

THE FOLLOWING WAS WRITTEN IN REPLY TO A TRUCK DRIVER QUESTIONING RULES OF FCSMA AND ADVOCATING ONLY THE USE OF CPAP. BECAUSE OF THIS DRIVER I ACTUALLY READ THRU THE RULES FOR THE FIRST TIME AND WAS APPALLED AT THE RECOMENDATIONS BECAUSE THEY ARE BASED ON FAULTY AND CONTRADICTORY STATEMENTS. I HAVE REPRINTED SECTIONS WITH MY COMMENTS. I BELIEVE THAT THERE IS AN UNFAIR BIAS TOWARD CPAP DUE TO IGNORANCE, COMFORT LEVELS, HISTORICAL STUDIES THAT LOOKED AT CPAP AS THE ONLY TREATMENT AND ENORMOUS AMOUNTS OF CASH THAT CPAP COMPANIES CONTROL. IF CPAP IS THE BEST TREATMENT IT SHOULD CERTAINLY BE USED BUT IT IS DISHONEST TO SAY MINIMAL TO PARTIAL TREATMENT WITH CPAP IS BETTER THAN COMPLETE AND EFFECTIVE TREATMENT WITH AN ORAL APPLIANCE. DENTAL SLEEP MEDICINE HAS AN IMPORTANT ROLE IN THE GLOBAL TREATMENT OF SLEEP APNEA.


I had not read the report "Expert Panel Recommendations Obstructive Sleep Apnea and Commercial Motor Vehicle Driver Safety" and have only read thru it briefly to this point. I do not know whether or not this report has been accepted by the Dept of Transportation and placed into written regulations. If it has been accepted as a DOT rule, I would absolutely advise every driver to follow these rules though they are seriously flawed based on research published after the date of this review. The medical review was seriously flawed an intellectually dishonest as I explain in some detail below. I will address this issue quite vocally. COMMENT: GUIDELINES ARE NOT NECESSARILY LAW.

I am 100% in favor of all patients, especially CMV drivers with OSA being treated totally. I also understand that yu were successfully treated with CPAP and I am sure from your discussion that you use it the recommended 7 1/2 hours every single night.

The report states that using CPAP 70% of nights for 4 hours a night is acceptable. It also states that AHI of 20 or less does not need to be treated. A paper presented 2 years ago at the Chest physicians meeting showed that patients with mild apnea and no symptoms of daytime tiredness had a 300% increase in MVA's with serious injury to one ore more occupants of vehicles.

The report states
"A diagnosis of obstructive sleep apnea, however, should not exclude all individuals with the
disorder from driving a CMV; certification may be possible in some instances. An individual with
a diagnosis of obstructive sleep apnea may be certified to drive a CMV if that individual meets
the following criteria:
– Has untreated obstructive sleep apnea with an AHI ≤ 20, AND COMMENT: THIS LEVEL OF UNTREATED APNEA SHOULD ABSOLUTELY PRECLUDE DRIVING....SLOWER RX TIMES THAN LEGALLY INTOXICATED
– Has no daytime sleepiness, OR COMMENT: THIS STATEMENT HAS BEEN SHOWN TO NOT BE A RELIABLE ASSESSMENT TOOL
– Has obstructive sleep apnea that is being effectively treated. " COMMENT: THIS IS WHAT ORAL APPLIANCES DO BUT IT MUST BE CONFIRMED BY FOLLOW-UP TITRATION BY POLYSOMNOGRAPHY!!!

"An individual with OSA who meets the requirements for certification described above should be
recertified on an annual basis, based on demonstrating satisfactory compliance with therapy. " COMMENT: THIS DOES MAKE SENSE WITH CPAP BUT ORAL APPLIANCE COMPLIANCE TESTING IS JUST COMING FORWARD. OBJECTIVE TESTING IS ONLY NECESSARY IF YOU BELIEVE TRUCK DRIVERS CAN NOT BE TRUSTED TO BE TRUTHFUL ABOUT APPLIANCE USE.

OBJECTIVE TESTING WILL BE AVAILABLE IN THE NEXT FEW MONTHS. STUDIES DONE COMPARING ORAL APPLIANCE COMPLINCE AND CPAP SHOW MUCH HIGHER COMPLIANCE WITH ORAL APPLIANCE THERAPY THAN CPAP. MORE IMPORTANT IS THE FACT THAT PATIENTS UTILIZE CPAP MORE FREQUENTLY AND FOR MANY ADDITIONAL HOURS AS A GROUP THAN CPAP USERS.

EFFECTIVE TREATMENT WITH ORAL APPLIANCE IMPIES THAT POLYSOMNOGRAPHY HAS SHOWN THAT APNEA IS ELIMINATED/SUCESSFULLY TREATED.

The next statement explains the folly of this report " Studies comparing individuals with
excessive sleepiness to those who do not have sleepiness find that having an apnea/hypopnea index ≥20
episodes/hour is a risk factor for excessive sleepiness (Pack et al. 2006). The expert panel thus believed
that individuals with an AHI <20 who were not excessively sleepy could be certified to drive." IF TRUCK DRIVERS ARE NOT TRUTHFUL ABOUT WHETHER THEY USE CPAP THAN YOU CERTAINLY CANNOT BELIEVE THAT THEY ARE TRUTHFUL ABOUT DAYTIME SLEEPINESS. THEREFORE IT WOULD MAKE SENSE THAT EVERY DRIVER WITH ANY LEVEL OF APNEA SHOULD BE REQUIRED TO HAVE BOTH MSLT AND MWT TESTING TO INSURE PUBLIC SAFETY.

I WOULD PREFER TO TRUST DRIVERS TO BE TRUTHFUL BUT IF WE DO NOT TRUST THEM TO BE TRUTHFUL ABOUT APPLIANCE USE THAN WE SHOULDN'T TRUST THEM TO BE TRUTHFUL ABOUT TIRDNESS.

THE NEXT ISSUE I HAVE IS IN THIS ASPECT
Guideline 2: Specific Guideline Statement 1 – Drivers who should be
disqualified immediately or denied certification
The Medical Expert Panel identified several populations of individuals who they believe should not be
certified or recertified as being medically qualified to drive a commercial motor vehicle. These
populations are:
• Individuals that report that they have experienced excessive sleepiness while driving, OR ARE THEY TRUTHFUL?
• Individuals who have experienced a crash associated with falling asleep, OR ARE THEY TRUTHFUL?
• Individuals with an AHI that is greater than 20, until such an individual has been adherent to
Positive Airway Pressure (PAP). They can be conditionally certified based on the criteria for
CPAP compliance as outlined in Guideline 3 OR
• Individuals who have undergone surgery and who are pending the findings of a 3 month post- operative evaluation.
• Individuals who have been found to be non-compliant with their treatment at any point, OR
COMMENT:
ACCORDING TO THIS IF A DRIVER MISSES CPAP 2 DAYS SHOULD BE DROPPED ...PERIOD.

• Individuals who have a BMI of greater than 33 kg/m2 (pending evaluation by a sleep study) (80percent of the panel)
COMMENT: THEY LATER DISCUSS GUIDELINES FOR CPAP USE THAT ARE INSUFFICIENT TO TREAT THE DISORDER 4 HOUR 70% 0F NIGHTS

The next section exposes how cost of tests is more important than safety of drivers and public
"One member of the expert panel was concerned that individuals with BMI between 30 kg/m2 and 33
kg/m2 were also at increased risk for OSA (Young et al., 1993). Dr Pack proposed that the cut-point for
determining who requires a sleep study be a BMI of 30 kg/m2. The other members of the panel were
concerned about the feasibility of this and noted that according to a recent study (Pack et al., 2006),
41.9% of truck drivers would have to be given only temporary certification, pending a sleep apnea
evaluation, based on this recommendation. If 33 kg/m2 is used, this number of drivers to be studied drops
substantially since 24.0% of drivers have a BMI greater than 33 kg/m2. Moreover, by focusing on this
group, the majority of the panel believed that we would identify the vast majority of commercial drivers
with severe sleep apnea. "
COMMENT: THE TESTING IS BEING LIMITED TO BMI OVER 33 BECAUSE AT 30 BMI TO MANY TRUCKERS MIGHT BE AFFECTED. THEREFORE IGNORE THE EVIDENCE.

IN TRUTH, TESTING OF 100% OF COMMERCIAL DRIVERS SHOULD PROBABLY BE CONSIDERED BECAUSE SO MANY PATIENTS WITH SLEEP APNEA DO NOT FIT THE "TYPICAL IMAGE" OF OVERWEIGHT BIG NECK ETC.

FROM REPORT "Risk factors for obstructive sleep apnea are:
– Advancing age
– BMI ≥28 kg/m2 NOTE BMI 28 BUT PREVIOUS THEY DID BMI33 CUT OFF
– Small jaw
– Large neck size (≥ 17 inches (male) ≥15.5 (female))
– Small airway (a narrow or edematous oropharynx)
– Family history of sleep apnea " COMMENT: THESE PATIENTS SHOULD ALSO BE TESTED!

COMMENT: ANOTHER FOOLISH ASPECT OF THIS REPORT CAN BE FOUND HERE
" Individuals recently diagnosed with OSA may be conditionally certified for one month during
which time they will be started on CPAP therapy. At the end of this month, they can be
conditionally certified for 3 months if compliance to CPAP is documented in the two previous
weeks. Compliance should be reassessed at 3 months. If at the three month assessment such an
individual demonstrates treatment compliance, that individual may be certified for a period of one
year. The commercial driver needs to receive information that if they stop using their CPAP
during this one year period, they should stop driving a commercial vehicle." COMMENT: A TRUCKER CAN BE BELIEVED HE IS UTILIZING CPAP IF HE USES IT FOR 3 MONTHS AND NO LONGER NEEDS MONITORING. WHY IS HE MORE BELIEVABLE THAN A PATIENT UTILIZING AN ORAL APPLIANCE. IF MONITORING IS NECESSARY WHY SHOULD IT NOT BE CONTINUALLY MONITORED?

THE ACCEPTED TREATMENT PROTOCOL"Minimally acceptable compliance is defined here as greater than 4 hours of use for at least 70% of the days, based on current standards of practice (Gay P, Weaver T, Loube D, Iber C.
Evaluation of positive airway pressure treatment for sleep related breathing disorders in adults.
Positive Airway Pressure Task Force; Standards of Practice Committee; American Academy of
Sleep Medicine. Sleep 29:381-401, 2006)." COMMENT: THIS IS WIDELY CONSIDERED INSUFFICIENT. 4 HOUR NIGHTLY USAGE MEANS THAT IN THE EARL MORNING HOURS WHEN HEART ATTACKS, STROKES AND OTHER VASCULAR EVENTS OCCUR THE PATIENT HAS ALREADY ABANDONED USAGE. THIS IS NOT THE AMOUNT OF TIME TO MAKE DRIVERS AND THE PUBLIC SAFE BUT IS AN ARBITRARY FIGURE USED IN RESEARCH TO DESCRIBE SUCCESSFUL TREATMENT. SUCCESSFUL TREATMENT WITH CPAP IS 7 -7 1/2 HOURS EVERY SINGLE NIGHT.

THE ONLY REASON THIS IS NOT USE IN RESEARCH IS BECAUSE USING THAT GUIDELINE CPAP WOULD BE A FAILURE FOR OVER 75% OF PATIENTS. APPROXIMATELY ONE IN FOUR PATIENTS ARE SUCCESSFUL WITH CPAP USING THOSE DEFINITIONS. THOSE ARE USUALLY THE SAME PATIENTS THAT LIKE CPAP THERAPY FROM THE VERY BEGINING

• Individuals with OSA who are treated with PAP must demonstrate compliance with treatment and
this must be documented objectively
– Compliance is defined as using PAP for the duration of total sleep time.
• Optimal treatment efficacy occurs with seven hours or more of use during sleep; however, four hours of documented time at pressure per major sleep episode is minimally acceptable. COMMENT: DO WE REALLY WANT LESS THAN OPTIMUM TREATMENT IN OUR DRIVERS? IS OPTIMAL TREATMENT WITH AN ORAL APPLIANCE LESS ACCEPTABLE THAN SUB-OPTIMAL TREATMENT WITH CPAP? WHY? THIS IS LUDICROUS. THE ONLY REASON THIS IS ACCEPTABLE IS IF ALL TRUCK DRIVERS LIE! IF A TRUCK DRIVER WOULD BE HEALTHIER AND SAFER BY UTILIZING AN ORAL APPLIANCE THAN THERE IS NO QUESTION HE OR SHE SHOULD BE ENTITLED TO THE BEST TREATMENT AVAILABLE FOR THEM BE IT CPAP, A COMFORTABLE ORAL APPLIANCE OR SURGERY.

• Based on current standards of practice, an acceptable CPAP use is at least 4 hours of use per night on at least 70% of nights. COMMENT: DOES THIS MAKE ANY SENSE TO YOU????

THIS IS THE STATMENT ON ORAL APPLIANCES
"• Dental appliances and surgery are considered to be potential alternatives to PAP for the treatment of
obstructive sleep apnea.
– Currently there is no method of measuring compliance among individuals treated with dental
appliances. Consequently, use of dental appliances cannot be considered an acceptable alternative" COMMENT: THE ONLY REASON ORAL APPLIANCES ARE NOT CONSIDERED ACCEPTABLE IS THERE IS NO COMPLIANCE MONITOR. MONITORS ARE COMING VERY SOON!
to PAP in individuals who require certification to drive a commercial motor vehicle for the purposes of interstate commerce. COMMENT: THE REASON COMPLIANCE MONITORS ARE NEEDED? BECAUSE THE GOVERNMENT AND EMPLOYERS BELIEVE THAT TRUCK DRIVERS LIE AND CANNOT BE TRUSTED. IS THIS TRUE? IF IT IS THEN ANY SUBJECTIVE REPORTING MUST BE DISCARDED.

THESE STATEMENTS ARE TRUE. "An alternative therapy to nasal positive airway pressure is use of intra-oral devices worn during sleep.
These devices reposition the mandible thereby increasing the size of the upper airway. The benefit of
these devices has been shown in randomized trials (Chan et al., 2007). However, not all individuals
benefit from this therapy and in some subjects OSA may get worse (Henke et al., 2000). There is,
moreover, no method currently available to monitor compliance with this form of therapy. Given this,
and the variable efficacy with this treatment, the expert panel took the view that this form of therapy
could not be recommended for use in commercial drivers as an acceptable treatment for OSA." COMMENT: THIS IS WHY IT IS NECESSARY TO TO DO TITRATION POLYSOMNOGRAPHY ON ALL PATIENTS. IF ORAL APPLIANCES DO NOT SUCCESSFULLY TREAT THE PATIENT THAN ALTERNATIVE TREATMENT MODALITIES ARE NECESSARY.

UTILIZING CPAP 4 HOURS A DAY INSTEAD OF SUCCESSFULLY TREATING PATIENTS ALL NIGHT IS FOOLISH AND STATISTICS SHOW THAT 60% OF PATIENTS ABANDON CPAP AND AVE USE IS 4-5 HOURS A NIGHT 4-5 NIGHT A WEEK. THIS IS INSUFFICIENT.

I AM SURE THAT TRUCK DRIVERS SEE THE FOOLISHNESS OF THE COMPARISON.

++++JUST ADDED TO THIS BLOG!! +++++++FROM THE DOT
Medical Advisory Criteria for Evaluation Under 49CFRPart391.41
Print
Note Unlike regulations which arecodifiedand have a statutory base, the recommendations in this advisory are simply guidance established to help the medical examiner determine a driver's medical qualifications pursuant to Section 391.41 of the Federal Motor Carrier Safety Regulations (FMCSRs). The Office of Motor Carrier Research and Standards routinely sends copies of these guidelines to medical examiners to assist them in making an evaluation. The medical examiner may, but is not required to, accept the recommendations. Section 390.3(d) of the FMCSRs allows employers to have more stringent medical requirements

THESE ARE MERELY RECOMENDATIONS; READ FROM DOT AT THE FOLLOWING SITE
http://www.fmcsa.dot.gov/rules-regulations/administration/medical.htm.

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posted by Dr Shapira at 8:44 PM