At the recent MRO training course in Orlando, MROCC was proud to recognize Dr. Donna Smith with the MROCC Lifetime Achievement Award for her many years of tireless work for and contributions to the fields of occupational health, workplace safety, and substance misuse prevention and testing. As an MRO certification organization, we are not in the business of giving awards. This award was the first of its kind and very much deserved by Dr Smith.
Dr. Smith is currently the Regulatory Compliance Officer at WorkforceQA, a full-service Third Party Administrator for workplace safety and compliance programs. She is also the Quality Assurance Officer at Recovery Trek, a Third Party Administrator focused on Professional Health Monitoring.
She has over 35 years' experience and expertise in drug-free workplace program regulatory compliance. Dr. Smith has served in policy and regulatory positions with the U.S. Army, Department of Defense, and the Department of Transportation (DOT). While at the DOT, she was a principal author of the DOT drug and alcohol testing rules. She also served on the anti-doping task force of the International Olympic Committee.
Dr. Smith is a widely acclaimed speaker, educator, and author. She is a nationally recognized expert in the areas of federal drug testing regulations, drug and alcohol testing procedures, drug and alcohol abuse awareness training for employees and managers, medical review officer (MRO) procedures, drug-free workplace policy and procedures, and substance abuse prevention and rehabilitation.
Since 1990 she has served on the faculties of the American Society of Addiction Medicine (ASAM), the American College of Occupational and Environmental Medicine (ACOEM), and the American Osteopathic College of Occupational and Preventive Medicine (AOCOPM) for continuing medical education courses for physicians serving as Medical Review Officers (MROs).
Dr. Smith has served on the Substance Abuse and Mental Health Services Administration's (SAMHSA) Federal Drug Testing Advisory Board (DTAB), the Substance Abuse Program Administrators Association (SAPAA) Board of Directors, and currently serves on the Board of the Drug-Free America Foundation.
Dr. Smith also serves as a technical expert in the Professional Health Monitoring arena. Dr. Smith earned a BA in sociology from Capital University, an MSW in clinical social work from Hunter College, CUNY, and a PhD in counseling psychology from Ball State University.
In addition to her other work and contributions, Dr. Smith has also regularly contributed to the MROCC newsletter, has co-authored the MROCC MRO Manual, and has served on our Examination Development committee since the early 1990s.
From the Board Members and staff of MROCC, thank you Dr. Smith for all you have done and the continuous support you give to all.
On May 21, 2024, the Department of Justice (DOJ) Drug Enforcement Administration (DEA) published a Notice of Proposed Rulemaking (NPRM) to reschedule marijuana from Schedule I to Schedule III of the federal Controlled Substances Act (CSA). If the rule is finalized, marijuana would be considered a drug with "moderate to low potential for physical and psychological dependence" and would be available for medical use only at the federal level.
Under the federal CSA, the DEA classifies drugs into five distinct categories, or schedules, depending on the drug's acceptable medical use and its potential for abuse or dependence. Schedule I drugs are defined as having no currently accepted medical use and a high potential for abuse. Marijuana has been a Schedule I drug since the inception of the CSA in 1970. Schedule III drugs are defined as drugs with a moderate to low potential for physical and psychological dependence, and with accepted medical use. Some examples of Schedule III drugs are Tylenol with codeine, ketamine, buprenorphine, and anabolic steroids.
On October 6, 2022, President Biden released a statement asking the Secretary of the Department of Health and Human Services (HHS) and the Attorney General "to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law". August 29, 2023, HHS recommended to the DEA that marijuana be rescheduled to Schedule III, and in accordance with the CSA, DEA initiated formal rulemaking in the May 21, 2024 NPRM. If the transfer to Schedule III is finalized, any drugs containing marijuana will be subject to the applicable prohibitions in the Federal Food, Drug, and Cosmetic Act, enforced by the Food and Drug Administration (FDA). Additionally, if marijuana is transferred to Schedule III, the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA.
The NPRM set forth the following eight factors that are used when considering rescheduling. The conclusions reached by HHS and DOJ suggest that they do not agree on all of these issues and in its NPRM the DEA requests additional data through public comments.
Rationale for Schedule III
Impact on Employers and MROs
Comments on the NPRM may be submitted up until July 22, 2024 at the federal register website. The DEA may hold administrative hearings on matters of fact and law related to the rulemaking; notices of such hearings would be published in the Federal Register. It will likely take months for DEA to review the comments submitted, so it is unclear when or if a final rule may be issued.
What follows are some of the key areas where testing in Canada differs from the US. Of note, the information provided here is relevant to drug and alcohol testing in Canada and not related to the US Department of Transportation (US DOT) testing, other than where identified as follows.
For context, the US DOT 49 CFR Part 40 provides regulations on how to conduct required drug and alcohol testing and what procedures to use. These regulations apply to transportation employers, safety-sensitive employees — including self-employed individuals, contractors and volunteers covered by the DOT agency — and service agents. The sectors covered under these regulations are all federal aviation, motor carriers, railroad, transit, and pipeline and hazardous materials, as well as the US Coast Guard.
There are several overarching differences in workplace drug and alcohol testing between Canada and the US. The focus on testing in Canada is related to employer due diligence in providing safe workplaces. Any workplace testing is based on that goal and premise.
In Canada, there is no differentiation between legal and illegal substance use. An employer's responsibility is not enforcement or policing. Substance use that impacts safety is not influenced by the regulatory status of a drug; it is the action of the substance that negatively impacts the ability to work safely that is the concern. In Canada, employers are required to accommodate an employee confirmed to have a substance use disorder (SUD), as this is a protected ground from discrimination under Canada's federal Charter of Human Rights. As such, voluntary disclosure of an SUD is an integral component of drug and alcohol policies in Canada.
For the past 50 years, the alcohol level for criminality in Canada is 0.08% Blood Alcohol Concentration (BAC). However, it is scientifically recognized impairment with some individuals can occur at lower levels of alcohol. In recognition of this, many jurisdictions have reduced this level to 0.05%, and most workplaces follow 0.04% as per the US DOT. Unlike alcohol, there is not a consensus for any drug, from lab-based specimen analysis, at or above which will provide assurance of impairment. Positive test results for Oral Fluid (OF) are indicative of safety risk, not impairment.
There are additional areas where drug and alcohol testing in Canada differ from the US. What has been identified here is a high-level overview. There are benefits to lack of regulation for employers conducting drug and alcohol testing in Canada primarily related to autonomy and flexibility. The downside to this is that in the absence of regulatory direction, there is much inconsistency and confusion. The result is a wide variance in employer policies and procedures, and a frequent lack of adherence to best practices. The best way to ensure drug and alcohol programs meet employer goals and are legally defensible is to stay current and informed through access to reputable and credible references and resources.
Recently, MROCC and other professional societies were invited to participate in a survey evaluating case scenarios related to urine drug test (UDT) interpretation. The survey was sponsored by the Association for Diagnostics and Laboratory Medicine (ADLM), with the goal of identifying educational needs in a diverse group of healthcare professionals. Interpretative questions were developed by volunteers from ADLM's Toxicology and Therapeutic Drug Monitoring division, and vetted by independent expert laboratorians. The questions covered a variety of topics ranging from basic knowledge of immunoassay screen cross-reactivity to more advanced case scenarios such as simulated compliance.
Over 900 clinicians and laboratorians responded to the survey during 2020-2023. The largest respondent group comprised 'MD or equivalent' participants (n=510), 126 of which were from MROCC. Physician respondents reported a broad range of specialties, training/experience, and confidence in UDT interpretation. Respondents from MROCC reported notably more experience and confidence in UDT interpretation compared to physicians from other organizations, and compared to the full group of respondents (Table 1).
Table 1. Self-reported training/experience and confidence in urine drug test interpretation.
Training/experience in UDT interpretation | ||||
N | Extensive | Moderate | Little/None | |
MROCC (MD & APP) | 129 | 48 (37.2%) | 65 (50.4%) | 16 (12.4%) |
Other MDs | 383 | 68 (17.8%) | 112 (29.2%) | 203 (53.0%) |
All respondents | 909 | 194 (21.3%) | 296 (32.6%) | 419 (46.1%) |
Confidence in UDT interpretation | ||||
N | Extremely | Generally | Somewhat/ Not at all | |
MROCC (MD & APP) | 128 | 38 (29.7%) | 74 (57.8%) | 16 (12.5%) |
Other MDs | 382 | 53 (13.9%) | 118 (30.7%) | 211 (55.2%) |
All respondents | 907 | 156 (17.2%) | 324 (35.7%) | 427 (47.1%) |
APP: advanced practice professional; MD: medical doctorate; UDT: urine drug testing |
Each respondent answered 6 out of 11 interpretative questions developed by the project team (the number of questions each participant saw was limited to reduce the time required to complete the survey). The mean number of correct responses for all respondents was 4.04 out of 6 possible. Physician respondents on average answered 4.14 questions correctly, ranging from 4.82 for MD toxicologists to 3.66 for primary care and internal medicine (PCIM) physicians (Table 2). Respondents from MROCC averaged 4.05 correct answers.
Table 2. Survey responses by physician specialty.
MD respondents, by specialty | N (% of MDs) | Mean Correct (SD) | p (vs Toxicology) |
Clinical or medical toxicology | 28 (5.5%) | 4.82 (1.31) | Ref. |
Addiction medicine | 39 (7.6%) | 4.56 (0.94) | n.s. |
Psychiatry | 22 (4.3%) | 4.55 (1.06) | n.s. |
Pain management | 23 (4.5%) | 4.39 (1.03) | n.s. |
Emergency medicine | 121 (23.7%) | 4.26 (1.29) | 0.02 |
Pathology | 43 (8.4%) | 4.19 (1.28) | 0.03 |
Occupational medicine | 73 (14.3%) | 4.18 (0.98) | 0.01 |
Primary care and internal medicine | 132 (25.9%) | 3.66 (1.22) | <0.0001 |
n.s.: not significant; SD: standard deviation. |
The survey results highlighted areas of UDT where additional education could benefit respondents from all backgrounds and specialties. The full study, entitled 'Assessing Knowledge Gaps and Educational Needs in Urine Drug Test Interpretation Among Healthcare Professionals' will be published this summer in American Journal of Clininical Pathology. The following case scenarios from the survey are of particular relevance to MROCC.
CASE 1: A patient prescribed Ativan (lorazepam) has a negative urine immunoassay screen for benzodiazepines. Which response is correct?
RESULTS: 67.2% of all respondents and 41.7% of MROCC respondents correctly identified that benzodiazepine immunoassay screens can have falsely negative results for lorazepam, and that confirmation testing is warranted. 33% of MROCC participants incorrectly responded that the negative screen proves noncompliance.
EDUCATIONAL EMPHASIS: All immunoassay drug screens have the potential for both false positive and false negative results, and should never be considered definitive. Benzodiazepine screens in particular are often poorly sensitive for conjugated metabolites such as lorazepam-glucuronide, the predominant form of lorazepam in urine. Although some assay manufacturers have recently incorporated enzymatic removal of glucuronide conjugates to improve benzodiazepine detection, individuals interpreting UDT screening results should recognize the potential for poor cross-reactivity and the importance of confirmation testing by mass spectrometry to resolve unexpected results.
CASE 2: A patient prescribed oxycodone is positive on her urine confirmation test for oxycodone (40,000 ng/mL) and hydrocodone (5000 ng/mL). What is the best interpretation?
RESULTS: 54.9% of all respondents and 64.1% of MROCC respondents correctly recognized that these drug concentrations are most consistent with co-ingestion of oxycodone and hydrocodone. 30.1% of MROCC respondents incorrectly answered that hydrocodone is a metabolite of oxycodone.
EDUCATIONAL EMPHASIS: Hydrocodone and oxycodone are distinct semi-synthetic opiates that do not share a common metabolic pathway. The primary metabolites of oxycodone are noroxycodone and oxymorphone (active); oxymorphone is further metabolized to noroxymorphone and oxymorphone-glucuronide. Hydrocodone metabolites include norhydrocodone, dihydrocodeine, and hydromorphone (active); the latter two compounds can also form glucuronide conjugates.
CASE 3: Your patient has a history of heroin use. A urine opiate screen is positive and confirmation shows 250 ng/mL of morphine. 6-monoacetylmorphine (6-AM) is undetectable. Which response is correct?
RESULTS: 73.5% of all respondents and 73.8% of MROCC respondents correctly recognized that 6-AM is not always present after remote heroin use. 23.3% of MROCC respondents incorrectly answered that undetectable 6-AM rules out heroin use.
EDUCATIONAL EMPHASIS: Short half-life compounds such as heroin, 6-AM, and cocaine are eliminated shortly after use, even with relatively concentrated matrices such as urine. Downstream metabolites such as morphine (for heroin/6-AM) and benzoylecgonine (cocaine) might be the only remaining evidence of substance use. Detection windows vary depending on the compound, dose, and individuals' clearance, but in general the parent drugs heroin and cocaine will be undetectable within hours and 6-AM may only be detectable within 1 day of heroin use.
CASE 4: A patient prescribed Suboxone (buprenorphine/naloxone) has urine confirmation results (in ng/mL): 10,000 buprenorphine, 50 norbuprenorphine, 2,500 naloxone. What is the best interpretation?
RESULTS: 39.5% of all respondents and 38.5% of MROCC respondents correctly identified sample adulteration with Suboxone to simulate compliance. 42.3% of MROCC respondents incorrectly answered that the norbuprenorphine to buprenorphine ratio indicates compliance.
EDUCATIONAL EMPHASIS: Addition of prescribed medications to urine samples to simulate compliance can occur with any high-risk therapeutic including opioids and medication-assisted therapies. Presence of metabolites, while suggestive of at least partial compliance, does not rule out addition of medication directly to the sample. Very low metabolite to parent ratios are a potential indicator of sample adulteration, although the expected ratios vary depending on the parent compound and metabolite(s) tested. In this scenario, a metabolite:parent ratio of 0.005 is well below the published threshold of 0.02 for suspecting buprenorphine adulteration. An additional clue in this scenario is the presence of naloxone in a 1:4 ratio with buprenorphine; naloxone is poorly absorbed orally but present in Suboxone at 1/4th the concentration of buprenorphine.
The Occupational Toxicology Section of the American College of Occupational and Environmental Medicine (ACOEM) is a newer special interest section within ACOEM. Following the American Occupational Health Conference (AOHC) in spring 2022, ACOEM members Dr. Beth Baker and Dr. John Downs (both medical toxicologists) felt that toxicology-related content at AOHC could be improved and that ACOEM members with a background in medical toxicology or general toxicology would be interested in having a forum where clinical occupational toxicology topics could be discussed. Further, Dr. Baker and Dr. Downs recognized that occupational and environmental medicine (OEM) physicians had a role in establishing the specialty of medical toxicology, but that the vast majority physicians now training in medical toxicology come from an emergency medicine background. A special interest section for occupational toxicology could be helpful to reinvigorate physicians with an OEM background to pursue additional training in toxicology, or to develop unique curriculum for training in occupational toxicology.
In summer 2022, Dr. Baker and Dr. Downs surveyed ACOEM membership with reported expertise in toxicology to assess for the desire for toxicology interest section to be created and willingness to participate. The response from ACOEM was positive, and a formal proposal was submitted to, and approved by the ACOEM Board of Directors in November 2022. Initial section members and other interested ACOEM members had the first in-person meeting of the Occupational Toxicology section at AOHC 2023 in Philadelphia.
Goals for the Occupational Toxicology section are to:
In its short existence, the section has thus far been successful in providing unique educational experiences in occupational and environmental toxicology for ACOEM members. At AOHC 2023, the section sponsored a well-received plenary session regarding the glyphosate cancer controversy. More recently at AOHC 2024, the section sponsored two plenary sessions entitled "Decoding the safety data sheet" and "Anecdotes and Antidotes: evolved thinking for workplace antidotes." Additionally, the section also co-sponsored two additional plenary sessions in conjunction with Veterans Administration physicians on military occupational and environmental exposure hazards.
The section was again able to meet in-person at AOHC 2024 to discuss potential initiatives for the upcoming year. Section members were reminded that ACOEM Connect provides a platform for communications between section members to discuss unique case presentations or new toxicologic questions. Section leadership is already working on developing proposals for educational content for next year's AOHC (April 27 - 30, 2025) in Austin, Texas. Possible future content may include impact of microplastics on human health in conjunction with the ACOEM Environmental Health section, and a review of the literature regarding occupational exposures to Per- and polyfluoroalkyl substances (PFAS). Occupational toxicology section members have also expressed interest in partnering with the ACOEM medical review officer section to discuss novel drugs of abuse.
For those interested in becoming an ACOEM Occupational Toxicology section member, they can simply add section membership when initiating or renewing ACOEM membership. Many current section members are board certified by the American Board of Medical Specialties (ABMS) in medical toxicology or by the American Board of Toxicology (ABT) in general toxicology, but section members need not have formal training or certification in toxicology. As with all other ACOEM special interest sections, the annual membership fee is $25. For questions about the group, please feel free to email Dr. John Downs (email: downsjw2000@gmail.com) for more information.
On June 21, 2024 the Department of Transportation (DOT) published three notices in the Federal Register relating to its May 2, 2023 final rule that, among other items, authorized employers to use oral fluid drug testing as an alternative testing methodology to urine drug testing. Complete information is available on the DOT website. Please note: this link was updated 8/5/2024 to reflect the most recent action on this notification.
The National Laboratory Certification Program (NLCP) sent a reminder of the July 19, 2024 deadline for MROs to submit their semiannual reports on federal agency specimens that were reported as positive for a drug or drug metabolite by a laboratory and verified as negative. Register and submit your report through the NLCP online. Please note that this requirement only applies to HHS-mandated drug testing. It does not apply to DOT or NRC testing.
ODAPC - DOT
SAMHSA - HHS
NRC
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Editor: James Ferguson, DO
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©2024 Medical Review Officer Certification Council
ISSN: 2833-0870
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