On October 1, 2010 the DOT (U.S. Department of Transportation) made some changes to their drug testing requirements. One of these changes is the addition of 6-Acetylmorphines or 6-AM to the list. 6-AM is a short-lived metabolite of heroin. It is produce in the body only from heroin and not from other opiates like codeine or morphine. Therefore, the presence of 6-AM in a specimen would be a clear indication of heroin use...or would it?

While it is true that 6-AM is a metabolite resulting only from heroin use, it is also an impurity present in the manufacture of legitimately prescribed opiates such as Oxycontin®, Vicodin®, morphine, and others. This impurity is not known to pose any harm to the patient taking the prescribed drug, but it may be detected by drug tests. This was not an issue until the DOT initiated its new, more sensitive test for 6-AM.

There is no way in the lab to differentiate if 6-AM is present because of appropriately prescribed pain medication or because of heroin use. However, when 6-AM shows up on a drug test, the donor and his or her employer should care about where it came from!

The American Association of Medical Review Officers (AAMRO) has put out an alert regarding a potential problem with the new requirement to test for 6-Acetylmorphines as an indicator for heroin use. The Federal Transit Administration (FTA) does not seem to agree. Here is what the FTA said in Drug and Alcohol Regulation Updates, Issue 42, Summer 2010:

"An additional test for 6-Acetylmorphines (6-AM) will be conducted for opiate positives above the initial test cutoff concentration of 2000 ng/mL. The 6-AM test is a definitive marker for heroin use. There is no legitimate medical explanation for 6-AM positive tests. The MRO must confer with the laboratory to determine if there was confirmed morphine below 2000 ng/mL."

This is a case where the various agencies are contradicting each other. The DOT says that 6-AM is a definitive marker for heroin and no other medical explanation can be entertained. The Food and Drug Administration (FDA), on the other hand, says that 6-AM is an impurity in the manufacture of a variety of controlled substances which may be legitimately prescribed.

The AAMRO says that the presence of this impurity will present, "A significant technical issue for MRO verification of 6-AM in DOT and HHS [Health and Human Services] urine tests." They say this problem will arise because "6-AM is present in very low levels in pharmaceutical morphine preparations."

At very low levels, this 6-AM might not be detected. But for people with prescriptions for high-strength opioid pain killers, it might be possible for levels of 6-AM to be detected that exceed established thresholds.

Laboratories involved with monitoring opioids have known about "process impurities" for a long time, but workplace drug testing lab have never had to deal with it.

The current regulations do not address this problem. This could become a serious "technical issue" for companies who find out certain employees are "heroin users" and for those employees who lose their jobs because they were taking prescription pain killers.

According to the AAMRO, the best course of action in the case of 6-AM detection in a donor who is taking a prescription opioid pain killer:

  • The Medical Review Officer (MRO) should follow current guidelines, taking care to address safety concerns
  • The MRO should contact the appropriate regulatory body for additional guidance
  • The MRO should ethically discuss the possibility of "process impurities" with the donor.

References:

http://www.aamro.com/docs/news/27.pdf

http://en.wikipedia.org/wiki/Monoacetylmorphine

http://transit-safety.volpe.dot.gov/drugandalcohol/Newsletters/issue42/pdf/Issue42.pdf

http://arthritisinsight.com/medical/meds/opiates.html

http://www.fsijournal.org/article/S0379-0738%2898%2900074-7/abstract

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