Safety advisories for impairing medications

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CanadianMRO
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Safety advisories for impairing medications

Post by CanadianMRO » Thu Jan 09, 2020 3:07 pm

If an individual is taking a prescribed drug which CAN result in cognitive impairment (ie. opioids), what would be required for the MRO to verify (or overturn) the result to a full negative (as compared to a negative with a safety-advisory)? Whose responsibility is it, in the end, to make sure that the donor is not impaired while taking their prescribed drug? We know the MRO is NOT the prescribing physician so if the prescribing physician provides a medical variance (stating they know the donor’s job duties as well as medical info) and that THEY feel the donor is able to safely fulfill their job duties while taking the prescription as set out, should the MRO then turn-over the negative with a safety advisory? Or, should the MRO be advising the employer of this information and leaving it in the employer’s hands to follow-up with a Medical Examiner (as they see fit) to confirm the fitness-of-duty of the donor/employee in question?

We are finding there are large variances between MROs and how they give out/don’t give out negative with safety advisories. We would like a clear picture of when a result should be released as negative with a safety advisory and when it should just be a negative. And, to confirm that in the end, the responsibility for the donor/employee being safe on the road, is that of the employer.



Robert Swotinsky MD
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Re: Safety advisories for impairing medications

Post by Robert Swotinsky MD » Sun Jan 12, 2020 9:48 pm

If an individual is taking a prescribed drug which CAN result in cognitive impairment (ie. opioids), what would be required for the MRO to verify (or overturn) the result to a full negative (as compared to a negative with a safety-advisory)? Whose responsibility is it, in the end, to make sure that the donor is not impaired while taking their prescribed drug.
The DOT procedures direct MROs to respond to likely safety and medical qualification concerns by alerting someone who can take action. Some MROs have opined that the option is really a responsibility. That's a matter of opinion, one that has not been legally tested nor is it addressed in ethical guidelines for MROs, e.g., not addressed in ACOEM's Ethical Aspects of Drug Testing as reaffirmed in July 2019. If an MRO responds by alerting someone who can take action -- for example, the designated employer representative -- the next step is to have a local expert assess the safety or medical qualification concern and determine fitness for duty. The MRO doesn't make assessment - it's made by someone who can and hopefully will take the time to gather whatever information is needed to make a decision.
if the prescribing physician provides a medical variance (stating they know the donor’s job duties as well as medical info) and that THEY feel the donor is able to safely fulfill their job duties while taking the prescription as set out, should the MRO then turn-over the negative with a safety advisory?
No. Again, per the DOT procedures, if the prescribing physician agrees to change to a different medication, one that doesn't raise a safety or qualification concern in the MRO's opinion, the MRO can then decide there's no longer a concern. The question posted about getting an "ok to work" note by the prescriber implicitly raises one type of concern - we all know that "ok to work" notes are often given out primarily to meet the patient's stated need and not because the prescriber has gathered information and made a thoughtful analysis. My answer posted about having the prescriber agree to change meds raises a different type of concern - many of the risky meds cause dependence, so it seems unlikely that a patient will stop taking a drug like this just because a prescriber told the MRO they'd stop taking it.
should the MRO be advising the employer of this information and leaving it in the employer’s hands to follow-up with a Medical Examiner (as they see fit) to confirm the fitness-of-duty of the donor/employee in question?
Yes. On my reports, I write: "During the review of this test, a safety concern was identified. This concern can best be resolved by having the donor evaluated by the employer's local occupational health services provider. That provider can call me for further detail about the concern. / Robert Swotinsky, MD; 882-394-1192 c" (not my real number) btw, I have written this on hundreds of reports to employers in the past several years and I recall one, maybe two, times that a local provider called me in response. I would be interested in other MRO approaches that appear more effective but not overly obtrusive.

BradWalshMD
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Re: Safety advisories for impairing medications

Post by BradWalshMD » Mon Jan 13, 2020 1:23 pm

On that note, I have a question regarding the regulations of issuing a safety concern. I have operated under the assumption (which possibly is false) that if the safety concern was presented to the donor, and in the allotted 5 day time period the prescribing physician contacted the MRO and stated that he/she would alter the sig or drug to a safer alternative, that at that point a safety concern could NOT be issued to the employer. This never sat well with me as you alluded to, changes aren't likely to actually take place. Is that the case, or does the MRO have the ability to make a notification similar to your example directly to the employer even if the prescriber states changes will be made? I can see both sides of the coin, but erring on the side of safety (the name of the game?) one would think it would make the most sense to bring these concerns to light and evaluate.

Robert Swotinsky MD
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Re: Safety advisories for impairing medications

Post by Robert Swotinsky MD » Mon Jan 13, 2020 9:18 pm

As of 11/13/17:
40.1235(e) You must also advise the employee that, before informing any third party about any medication the employee is using pursuant to a legally valid prescription consistent with the Controlled Substances Act, you will allow 5 business days from the date you report the verified negative result for the employee to have the prescribing physician contact you to determine if the medication can be changed to one that does not make the employee medically unqualified or does not pose a significant safety risk. If, in your reasonable medical judgment, a medical qualification issue or a significant safety risk remains after you communicate with the employee’s prescribing physician or after 5 business days, whichever is shorter, you must follow §40.327. If, as the MRO, you receive information that eliminates the medical qualification issue or significant safety risk, you must transmit this information to any third party to whom you previously provided information under §40.327.
As I read it, the MRO has discretion to decide that a safety concern remains, even if the prescribing physician contacts the MRO and says he/she will stop prescribing the drug of concern. For example, if the MRO learns that the donor has been getting 10 mg oxycodone #180/month and the prescriber calls the MRO and says he/she will stop prescribing oxycodone, it would be reasonable in my opinion for the MRO to nevertheless report a likely safety concern.

BradWalshMD
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Re: Safety advisories for impairing medications

Post by BradWalshMD » Tue Jan 14, 2020 9:31 am

Interesting. As it was presented in my course it was more of a "handcuffed" model where employee privacy seemed to trump MRO gut opinion when the "OK I'll change it" was given from the prescriber. I appreciate your advice. Would be good to go back to review cases where a concern could have been generated but was not based on that. Thank you.

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