Note from the Editor

JAMES FERGUSON, DO
Vault Health

MRO skills and thought processes can be applied in many different practice settings in addition to workplace drug testing. A prime example of this is the MRO review of drug testing done for monitoring those recovering from the disease of addiction. Monitoring has a two fold purpose. It provides a formal structure that encourages sobriety and it also provides forensic evidence of abstinence that can be crucial to those seeking license reinstatement and/or subsequent employment. Recovery monitoring is only one of the more complex MRO practices. We at the newsletter hope to bring you a series of papers over this and coming editions highlighting MRO practices outside of the more commonly found workplace arenas.

We also wanted to highlight the importance of comparing views about MROs and the drug testing arena from other areas of the world. This issue includes and article covering the drug testing process in Türkiye from Dr. Serap Annette Akgür.

Positive Toxicology Predictors

CHRISTOPHER J. HAMILTON, PhD, MPA and
LORI GOVAR, MSW, MBA

Abstract:

Random drug testing as a program component of professional monitoring programs like Physician Health Programs (PHP) provides a quantifiable measure of abstinence and serves as a deterrent to continued use of alcohol and other drugs. Individual invalid and dilute toxicology results are troubling for medical review officers, medical directors, and case managers to interpret and subsequently act on. A data set of 66,644 toxicology results among 1,185 professionals participating in PHPs and other structured monitoring programs are analyzed for Pearson Chi-Square and Cramer's V values to determine if invalid and dilute toxicology results are predictors of future subsequent positive toxicology. Dilute toxicology specimens are a predictor for subsequent participant positive toxicology specimens. Participants that produced dilute toxicology specimens are 60% more likely to produce future positive toxicology specimens (41.37%) when compared against participants who did not produce dilute toxicology specimens (25.32%). Invalid toxicology specimens are not a predictor of future participant positive toxicology specimens. The Pearson Chi-Square value is 29.583 with a probability of .000 with one degree of freedom indicating that there is a statistically significant relation between positive tests for participants who had previously produced a dilute toxicology sample. The Cramer's V value of .158 denotes that there is a relationship between the variables of dilute invalid toxicology and subsequent non-negative (positive) toxicology. These findings have policy implications for future toxicology collection procedures and expectations of donors following invalid and dilute specimens.

Read full article here

This article addressing the correlation between dilute specimens, invalid specimens and subsequent positive toxicology is the first of a series of articles on drug testing done for monitoring those recovering from the disease of addiction.

THC in Hair and the impact of over-the-counter products

MICHAEL A. PEAT, PhD
Forensic Toxicologist

A Brief Review of Beriges, M, Ketikidou, A, Weiskirchen, R et al. Manipulation of THC concentrations by commercially available products. Metabolites. 2022; 12: 900. https://doi.org/10.3390/metabo12100900

This article describes the impact of various over-the-counter products on the concentration of THC in hair samples and shows a significant impact of these products. The study appears to be well done with appropriate sampling, analytical methodology, statistical analysis, and interpretation.

A recent article in the Analyst by Eisneeiss et al¹ is a good review of cheating in hair testing and a Google search quickly finds more information on the topic. In the article referenced above the authors detail the use of hair testing for THC as a component of a drug testing procedure for a driving license re-granting process in Germany. In this process applicants are required to undergo random (24 hr notice) urine tests or alternatively hair tests covering a six-month period². For the hair test the labs need to detect THC in hair at a concentration of at least 0.02 ng/mg. which is below the Society of Hair Testing recommended cut-off of 0.05 ng/mg3.

Hair analysis can be complicated by cosmetic treatment, such as bleaching and coloring/dyeing^3,4 with one study⁵ showing a reduction of THC concentrations by 30% and 14% respectively. In the German program negative findings in obviously bleached or dyed hair must be supported by a urine analysis.

As stated by the authors:

"The aim of the study was to provide more information on the effect of these (pre)treatments on THC concentrations in hair."

They chose the following over-the counter products:

Seborin® Hair Tonic
Vodka Gorbatschow®
Zydot® shampoo
Desderman® disinfectant
Head and Shoulders® shampoo

Further details can be found for these products at various URLs.

As we all recognize with these types of studies it is important that appropriate sampling procedures are used, and this is one of the study's strengths. They used two groups of samples. One used hair samples from their own data base and only samples with no visible or mentioned chemical pretreatments or dyeing procedures. Fifty-four samples from the back of the head were used and divided into two. One was used for pretreatment with the products above and the other served as its own control. The number of paired samples used in each group is shown Table 1.

For each pretreatment between 3 and 6 cm of the hair strand was washed three times with the product for 30 mins and then washed for 10 mins of distilled water after each cycle. Thus, each strand was pretreated for a total of 90 mins.

The second group of samples were from regular cannabis users. All were males and aged between 25 and 50 years. The hair colors were black/grey, full black , full blond, and full red. One portion of these collections were subject to the pretreatment schedule as above and another portion used as the control.

Each sampling of pretreated hair and controls were subject to a standard LC-MS/MS procedure, summarized as follows:

Prewash with dichloromethane followed by drying at 70° C
Cutting into 1 to 2 mm pieces and then 30 to 50 mg placed into silanized vials
Addition of THC-d3 followed by a methanol/buffer extraction and centrifuging. The supernatant was used for LC-MS/MS and THC and THC-d3 monitored.

Further details are available in the paper. Of note, the method had been validated according to the Guidelines for the German Association of Toxicology and Forensic Chemistry⁶.

After confirming normal distribution statistical analysis was performed using the Mann-Whitney U Test and significance set at p<0.05.

All ethical guidelines were followed by the authors.

All the necessary data were included in the paper in two figures. I am only providing a summary of that data. Table 1 slows the results of the pretreatments on the first group of samples (n=54).

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For the cannabis user samples the reduction depended upon the product with the hair tonic and disinfectant having the highest decreases and for one set the highest reduction was seen with the Head and Shoulders shampoo.

There are a few points to make from the data in Table 1:

There was more than a 50% average reduction, and this was for three washes with the product. One might expect greater reductions with daily washes.
In 14 of the 54 samplings the pretreatment led to a final concentration below the 0.02 ng/mg concentration and this is below the administrative cut-off used in the German Guidelines.
No attempt was made to separate the different phases of hair growth and the decreases were far higher than the measurement uncertainty of the method.

Recommendations for the analysis of hair for THC use include the analysis of the THC carboxylic acid metabolite and this appears to be more stable during the bleaching and dyeing process⁴. As the authors point out, the procedures used in the paper also extract cannabinoids from hair and therefore one would expect decreases in the metabolite concentrations as well. These may not be as much because of its reduced lipophilicity. The authors indicate that they plan to publish data on the THC metabolite in the near future.

The results in this paper may not be too surprising given the results from papers on bleaching and coloring/dyeing of hair^3-5. However, in my mind they demonstrate that caution should be taken in interpreting hair testing data in large scale testing programs that may use only hair. The German program recognizes this and recommends testing of urine samples in some circumstances.

REFERENCES

Eisenbeiss, L., Binz, T. M., Baumgartner, M. R., Kraemer, T., & Steuer, A. E. (2020). Cheating on forensic hair testing? Detection of potential biomarkers for cosmetically altered hair samples using untargeted hair metabolomics. The Analyst, 2020, 6586-6599. https://doi.org/10.1039/d0an01265c
Schubert, W, Dittment, V, and Brenner Hartman, J. Assessment Criteria: Judgement Formation in Medical-Psychological Driving Aptitude Diagnostics, 3rd edition; Kirschbaum Verlag; Bonn, Germany 2012
Cooper, G. A. A., Kronstrand, R., & Kintz, P. (2012). Society of Hair Testing guidelines for drug testing in hair. Forensic Science International, 218(1-3), 20-24. https://doi.org/10.1016/j.forsciint.2011.10.024
Usman, M., Naseer, A., Baig, Y., Jamshaid, T., Shahwar, M., & Khurshuid, S. (2019). Forensic toxicological analysis of hair: A review. Egyptian Journal of Forensic Sciences, 9(1). https://doi.org/10.1186/s41935-019-0119-5
Auwärter, V., Wohlfarth, A., Traber, J., Thieme, D., & Weinmann, W. (2010). Hair analysis for Δ 9-tetrahydrocannabinolic acid A—New insights into the mechanism of drug incorporation of cannabinoids into hair. Forensic Science International, 196(1-3), 10-13. https://doi.org/10.1016/j.forsciint.2009.12.023
Peters, F. T., Hartung, M., Herbold, M., & Schmitt, G. (2009). Appendix B: To the GTFCh Guidelines for quality assurance in forensic toxicological analyses. Requirements for the validation of analytical methods. Guideline of the German Society of Toxicology and Forensic Chemistry: Validation of methods (76: 185-208). Toxichem Krimtech.

Effective Cannabis Testing: The Importance of a Medical Review Officer

JENNY LYNN
CMO and Co-Founder, Hound Labs

The legalization of cannabis has impacted workplace drug testing almost as much as the Omnibus Transportation Employee Testing Act (OTETA) of 1991. This act first legislated mandatory random drug testing for all employees in safety-sensitive jobs in industries regulated by the Department of Transportation (DOT). Medical Review Officers (MROs) have also been greatly impacted by cannabis legalization, with changes affecting how they help employers and employees navigate workplace drug testing.

Workplace drug testing was never intended to "catch" employees using drugs; rather, its primary objectives are deterrence and education. The goals of the DOT testing program and the Occupational Safety and Health Administration (OSHA) are to ensure safe and healthful working conditions for workers and the public. This is a good framework for viewing all drug testing — including cannabis — and the role of an MRO.

MROs can be extremely helpful to employers, guiding them through the confusing landscape of cannabis legalization. Facilitating communication between physician, employer, and employee is even more important now that more than 105 million adults (21 and over) live in states with legal access to cannabis¹. MROs have not historically mediated alcohol testing due to its legal status, but cannabis — even legalized — is seen differently when it comes to MRO involvement. Because cannabis can also be prescribed for medicinal reasons, it presents the opportunity for MRO guidance.

In conversations with MROs and safety professionals, experts have highlighted several MRO initiatives that can benefit employers in the era of cannabis legalization.

PROVIDE GUIDANCE ON HOW TO CREATE AN EFFECTIVE PROGRAM

Drug testing programs vary by industry, state, and employer goals. However, MROs can help employers understand the most effective programs are those that are well-communicated to employees.

In achieving the dual goals of deterrence and education, employers who spend time educating their employees about the reasons behind specific policies will find the greatest success. A 2021 National Safety Council (NSC) survey of 500 employers and 1,000 employees shows less than 20% of employees say their companies are doing a good job informing employees about their workplace cannabis policies.²

The results of poor employee education surrounding workplace cannabis policies are clear. Without a well-communicated policy, employees may not know what behavior is acceptable, what substances are prohibited surrounding the workday, under what circumstances a cannabis test may be performed, and if their confidentiality will be protected.

In the end, employees need to know a drug testing program is designed to keep them safe at work. MROs can help educate employees about the impact of cannabis use on performance.

DISCUSS THE IMPORTANCE OF SAFETY AND FAIRNESS

Effective drug testing programs focus broadly on deterring use during the workday - rather than just narrowly focusing on identifying impairment. Deterring drug use is a proactive approach and can prevent incidents from occurring. Testing only to determine impairment after an incident is reactionary rather than preventative.

Balancing safety with fairness and communicating this goal creates a win-win for employers and employees. According to the previously referenced NSC study, employees who struggle with substance use experience higher absenteeism and reduced productivity.² These struggles can affect their colleagues who may feel the impacts of a colleague not contributing fully.

Another characteristic of a fair and effective drug testing program is the effort to identify employees who may need support. These scenarios shouldn't be viewed as punitive but rather opportunities to identify needs and provide access to resources. For example, the opiate crisis put a spotlight on far too many individuals whose addiction started with a prescribed substance. Workplace drug testing programs provide an important safety net for those at risk or suffering from addiction.

ENCOURAGE EMPLOYERS TO CONTINUE TESTING FOR CANNABIS

Although some employers have eliminated cannabis testing, most understand the need to continue deterring cannabis use during the workday. Even those who eliminated cannabis testing are beginning to understand the unintended adverse effects of their decision. The 2021 NSC report shows most employers who discontinued testing "reported seeing an increase in incidents or other workplace performance concerns."²

MROs can provide a valuable service by helping employers understand the impact of eliminating cannabis testing. Instead of removing cannabis testing entirely, employers can revisit their policies and clearly state what is, and is not, permissible during the workday.

DISCUSS THE LIMITATIONS OF CONVENTIONAL CANNABIS TESTS

MROs and employers understand that continuing to test for cannabis is challenging now that cannabis can be used legally for both medicinal and recreational purposes. That's because conventional cannabis tests such as oral fluid (saliva), urine, and hair were designed when zero-tolerance policies prevailed. Conventional cannabis tests have long detection windows that, while useful prior to legalization, are now problematic for two reasons. First, these tests can indicate non-negative results for cannabis use that occurred days, weeks, and months prior to the test. Second, these tests can violate an employee's privacy by detecting use outside the workday.

One of the primary roles of an MRO is protecting employees' privacy. Advising an employer to consider a cannabis breath test will not only help deter cannabis use during the workday but also protect employees' choices outside of work. Testing breath for cannabis gives employers the ability to limit the detection window of THC (the principal psychoactive compound found in the cannabis plant) to just a few hours — well within the workday. The objective data obtained by testing breath helps employers enforce workplace policies, helps MROs ensure employees are treated fairly, and helps physicians make informed treatment decisions.

A CRITICAL ROLE

MROs play a critical role in balancing the needs of employers and employees during the era of cannabis legalization. They are a valuable resource to help employers create effective drug testing programs that achieve the goal of a drug-safe workplace in an increasingly complex environment. Employers who involve an MRO, in addition to working with their legal counsel, will create more effective drug testing programs.

REFERENCES

DOT PROPOSAL TO ALLOW THE USE OF ELECTRONIC SIGNATURES AND FORMS FOR 49 CFR PART 40 PROCEDURES

DONNA SMITH, PhD
WFQA, LLC Regulatory Compliance Officer

On August 5, 2022, The U.S. Department of Transportation (DOT) issued an Advance Notice of Proposed Rulemaking (ANPRM), Federal Register Vol. 87, No. 150 (pages 47951-47956). The ANPRM requested comments from the public, specifically DOT-regulated employers and their service agents (e.g. MROs and TPAs) who implement and administer drug and alcohol testing programs required by DOT agency (e.g. FAA, FRA, FMCSA, FTA, PHMSA) regulations. The subject of the ANPRM was the use of electronic forms and the electronic storage of forms and data required in the DOT's drug and alcohol testing procedures rule, 49 CFR Part 40.

This ANPRM was issued because of a statutory mandate placed on the DOT to amend its regulations to authorize, to the extent practicable, the use of electronic signatures or digital signatures executed to electronic forms instead of traditional handwritten signatures executed on paper forms. The DOT is required to issue such amendments to 49 CFR Part 40 no later than Feb 28, 2025. The DOT issued this ANPRM now to facilitate the timely proposal and adoption of the necessary Part 40 amendments to meet the statutory deadlines. The comment period for the ANPRM closed October 4, 2022.

The forms and records the DOT is considering for electronic signature, storage and data are:

Drug and alcohol background checks (§40.25-prior drug/alcohol violations)
MRO reports of verified drug test results
Substance Abuse Professional (SAP) reports
DOT Alcohol Testing Form (ATF)

The DOT has previously approved and authorized the use of electronic custody and control forms (eCCF) for documentation of DOT drug tests and is continuing to coordinate with DHHS to attain "totally paperless" eCCF systems at the HHS certified drug testing laboratories. The authorization of additional electronic forms and reports for DOT drug and alcohol testing would continue to allow the use of traditional paper or hard copy documents with wet signatures for maximum employer and service agent flexibility.

Specific to the use of electronic or digitized MRO signatures, is the proposal to allow MROs to verify DOT drug tests without having a "paper copy" of the CCF copy 2 (MRO copy). The MRO report to the employer of the test result determination would no longer require a "wet ink" signature on either the CCF copy 2 or the MRO test result report transmitted to the employer. The ANPRM asked several questions about the security of the transmission of electronic records, and assuring limited access to any transmission, storage, or retrieval systems.

Most comments submitted to the ODAPC docket for the ANPRM favored the DOT's planned move toward the use of electronic signatures and the use of electronic form and records, and their transmission and retention/storage. The next step in the process will be a Notice of Proposed Rule Making (NPRM) providing specific procedures and requirements for the use of electronic signatures, forms and records that are utilized for compliance with 49 CFR Part 40. This step will also include a period for public comment. If you are subscribed to the ODAPC list-serve, you will receive a notice when the NPRM is posted (Get ODAPC Updates by Email | US Department of Transportation).

The full text of the DOT ANPRM can be found at: https://www.govinfo.gov/content/pkg/FR-2022-08-05/pdf/2022-16862.pdf.

To read or review the comments submitted to the docket go to https://www.regulations.gov/docket/DOT-OST-2022-0027/document

Workplace Drug Test Applications and MRO Instructions in Türkiye

SERAP ANNETTE AKGÜR
Prof. Dr. Ege University, Institute on Drug Abuse, Toxicology and Pharmaceutical Science and
SINAN AYTAÇ POLAT, MD, PhD, Aviation Medical Center-AME, Private Antalya MLP Hospital Antalya

Increasingly widespread individual and social problems related to drug abuse/use have triggered new regulations for workplace drug testing approaches in the world¹. Among these approaches, drug testing system was the area that showed the most improvement. Depending on this situation, new regulations on the evaluation and interpretation processes of rapidly developed drug tests become mandatory. It is an expected situation that drug testing practices in the world vary between continents and countries. As it is known, Türkiye, as a member of many leading organizations such as UN/UNODC, European Union/EMCDDA, continues its efforts to combat drugs with a multidimensional perspective.

In our country, with the 84th Article of the Labor Law numbered 4857, which was first enacted in 2003; "Coming to the workplace drunk or taking drugs and using alcohol or drugs at the workplace" is prohibited². With the Occupational Health and Safety Law, which came into force in 2012, this article of the Labor Law was repealed, and the subject was included in the Occupational Health and Safety Law and 28/1 of the law. Again, "Coming to the workplace drunk or taking drugs and using alcoholic beverages or drugs in the workplace" is prohibited³. Article 4 of the Occupational Health and Safety Law obliges the employers to "Be responsible for ensuring the health and safety of the employees" and "Monitoring and supervising whether the occupational health and safety measures taken in the workplace are complied with and eliminating the non-compliances".

In this context, it is seen that alcohol and drug tests are conducted on behalf of employers by Occupational Health and Safety Law No. 6331, during the recruitment process or in the continuation of business activities, depending on the nature of the job. Conducting said tests on behalf of employers, it aims both to supervise the work activities of the employees and to fulfill the requirements of the occupational health and safety legislation. Moreover, contrary to Article 28 of Law No. 6331, "the employees coming to the workplace intoxicated or taking drugs and using alcoholic beverages or drugs at the workplace" is considered a justifiable reason for termination of the employment contract. However, at this point, a very important issue to be considered is that Occupational Physicians did not receive any special training regarding these tests during their training. Therefore, it is possible that there is a lack of knowledge about the interpretation of tests. Again T.C. The SHT-APAM Instruction, published by the Ministry of Transport, General Directorate of Civil Aviation in 2014 and revised in 2019, is about the use of non-limited Alcohol and Psychoactive Substances by Aviation Personnel Subject to Control. With the instruction; "Alcohol and Psychoactive Substance tests are obligatory in some cases for flight crew members, cabin crew members, air traffic controllers, aircraft technicians, flight operations specialists and their candidates working in the field of civil aviation"⁴.

In this very important Instruction, unfortunately, the task of performing these tests is given to any employee of the company (provided that they have received the necessary training). This person does not even have to be a healthcare professional. There is no provision in the instruction regarding what the necessary trainings are, who or by whom they can be given, what subjects they will cover, and the duration of the training. In today's practice, any employee of the airline can be authorized to perform and interpret these tests with a very short training (perhaps half an hour or less) from a company that sells breathalyzer or psychoactive substance screening tests. However, it is known that the interpretation of the test results of these tests should be done by physicians who have received Medical Review Officer (MRO) Training. In this situation, it is not possible for the tests to be performed in the existing system to serve the purpose of the Instruction. This Instruction, made by civil aviation in our country, is made by different airline companies in different ways, for example, Turkish Airlines, Sun Express etc. take care to fulfill this duty with people who have received MRO training.

Unfortunately, clinical and forensic toxicology laboratory practices are not carried out separately in our country. In 2015, Ministry of Health published "Working Procedures and Principles of Confirmation Laboratories that Analyze Illegal and Abused Drugs and Substances in Urine Samples," with the circular numbered 2015-04. These Confirmation Laboratories have taken their place in the practices in our country in order to analyze the samples with positive results from the pre-screening test⁵. However, there is no information in this regulation about the training that the physicians (MRO) who will report these results should receive.

Workplace Drug Testing laws were created to protect the community from the harmful consequences that drug use can cause. By ensuring that these procedures are harmonized, fair and equal treatment can be ensured throughout the country⁶. With the cooperation of international organizations and people working in this field, substance testing practices and especially the interpretation of test results will be carried out more effectively. It is seen that international guidelines will guide national regulations in the process of eliminating the said deficiencies (especially the interpretation of results, MRO) in the current legislation and regulations regarding drug testing in the workplace in Türkiye.

REFERENCES

2023 DOT Random Testing Rates Notice

ODAPC's web site has been updated to reflect the CY 2023 random drug and alcohol testing rates. The table below outlines the 2023 DOT Random Testing Rates.

DOT Agency	2023 Random Drug Testing Rate	2023 Random Alcohol Testing Rate
Federal Motor Carrier Safety Administration [FMCSA] The random rates did not change for 2023. Because the random rates did not change, FMCSA is not required to publish a notice in the Federal Register. The rate last changed in 2020.	50%	10%
Federal Aviation Administration [FAA] 2023 Random Rate Federal Register Notice	25%	10%
Federal Railroad Administration [FRA] 2023 Random Rate Federal Register Notice	25% - Covered Service 25% - Maintenance of Way 50% - Mechanical (Effective 03/04/2022)	10% - Covered Service 10% - Maintenance of Way 25% - Mechanical (Effective 03/04/2022)
Federal Transit Administration [FTA] 2023 Random Rate Federal Register Notice	50%	10%
Pipeline & Hazardous Materials Safety Administration [PHMSA] 2023 Random Rate Federal Register Notice	25%	N/A
NOTE: Employers (and C/TPAs) subject to more than one DOT Agency drug and alcohol testing rule may continue to combine covered employees into a single random selection pool. USCG covered employees may be combined with DOT covered employees in drug testing pools even though the USCG is now part of the Department of Homeland Security.

Government Resource Websites

ODAPC - DOT

SAMHSA - HHS

NRC

10 CFR PART 26 - Fitness for Duty Programs

CUSTODY AND CONTROL FORMS (CCFs)

Medical Review Officer
Certification Council (MROCC)
3231 S Halsted St, Ste Front ###167
Chicago, IL 60608

Tel: 847.631.0599
Email: mrocc@mrocc.org

ISSN: 2833-0870

MRO Quarterly is an educational publication intended to provide information and opinion to health professionals. The statements and opinions contained in this document are solely those of the individual authors/contributors and not MROCC. MROCC and its editorial staff disclaim responsibility for any injury to persons or property resulting from any ideas or products referred to in this newsletter.

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