DRUG TESTS • DRUG TESTING IN THE WORKPLACE • OTHER RELEVANT INFO
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection.
“The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another testing innovation game changer that will reduce the demand for scarce testing resources,” said Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, M.D. “Our current national expansion of COVID-19 testing is only possible because of FDA’s technical expertise and reduction of regulatory barriers, coupled with the private sector’s ability to innovate and their high motivation to answer complex challenges posed by this pandemic.”
“Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s authorization is another example of the FDA working with test developers to bring the most innovative technology to market in an effort to ensure access to testing for all people in America. The FDA encourages test developers to work with the agency to create innovative, effective products to help address the COVID-19 pandemic and to increase capacity and efficiency in testing.”
SalivaDirect does not require any special type of swab or collection device; a saliva sample can be collected in any sterile container. This test is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past. Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources. Additionally, the SalivaDirect methodology has been validated and authorized for use with different combinations of commonly used reagents and instruments, meaning the test could be used broadly in most high-complexity labs.
Yale intends to provide the SalivaDirect protocol to interested laboratories as an “open source” protocol, meaning that designated laboratories could follow the protocol to obtain the required components and perform the test in their lab according to Yale’s instructions for use. Because this test does not rely on any proprietary equipment from Yale and can use a variety of commercially available testing components, it can be assembled and used in high-complexity labs throughout the country, provided they comply with the conditions of authorization in the EUA.
This is the fifth test that the FDA has authorized that uses saliva as a sample for testing. Testing saliva eliminates the need for nasopharyngeal swabs, which have also been prone to shortages, and alleviates the patient discomfort associated with these swabs. Since the saliva sample is self-collected under the observation of a healthcare professional, it could also potentially lower the risk posed to healthcare workers responsible for sample collection. While FDA has seen variable performance in tests using saliva, Yale School of Public Health submitted data with its EUA request from which the FDA determined that Yale’s test meets the criteria for emergency authorization when used to test saliva samples for SARS-CoV-2, the virus that causes COVID-19 infection.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
At least 30 states are reporting COVID-19-related spikes in fatal opioid overdoses and heightened concern about substance use disorders, according to the National Safety Council (NSC).
"The COVID-19 pandemic intensifies the threat of mental health distress in several ways, including stress caused by financial, employment [and] child/family care instabilities, as well as fear [for] themselves or loved ones being exposed to or infected by COVID-19," reported the nonprofit member organization based in Itasca, Ill.
"Extended social isolation can lead to the development of substance use disorders. Those with previous substance use disorders are even more vulnerable due to decreased accessibility to treatment, recovery supports and harm reduction services, all a result of the pandemic."
Additionally, the NSC warned employers that they must prepare for an increase in substance misuse.
"This could be a serious threat to worker safety and cost tens of thousands in productivity losses, absenteeism and presenteeism, and workers' compensation claims if employers do not plan ahead," the NSC said in a statement.
It's up to managers, with support from their leadership teams, to stem the substance addiction tide as workers, emotionally fragile after months of lockdown, return to the workplace.
"The threat of post-COVID rise in mental health and substance abuse problems is definitely something that has to be monitored as people return to work," said Moe Gelbart, director of practice development for California-based Community Psychiatry, an outpatient mental health organization.
"It's important to have clear boundaries and expectations, primarily related to work performance. And it's essential for managers to follow through on behaviors [that] cross the line, with a zero-tolerance policy on abuse related to the workplace."
Managers should take note because addiction and mental illness can poison a workplace culture.
"Substance abuse should be on companies' radars all the time and not just during a pandemic," said Mandie Conforti, director of health and benefits for Willis Towers Watson.
"According to the results of the Willis Towers Watson 2019 Emerging Trends Survey, only 22 percent of employers currently have a plan to implement programs to address opioid use, and 23 percent were considering initiatives to prevent opioid use."
While these data are specific to opioids, Conforti said employees suffering from any substance use disorder can impact workplace morale.
"Overall, substance use costs have risen for many employers, with several having high-cost claimants with over $200,000 in medical expenses over a three-month period," she said. "That's higher than many chronic medical conditions."
The goal is to blend compassion for the employee with the need to keep the workplace running smoothly while ensuring that all company procedures and obligations are met.
Getting ahead of the issue is of paramount importance for employers. These action steps should streamline that process.
Managers should address any performance issues or problematic behavior, but not jump to conclusions about the underlying cause.
"Managers should discuss performance concerns and leave the door open for the employee to bring up any conditions or personal problems they are comfortable discussing," said Kristen Wilhelm, owner at Orchard HR LLC, a human resources outsourcing firm in Nashua, NH.
If the employee chooses to share information about a substance abuse issue, the manager should be ready to provide information about an available employee assistance program (EAP), leaves of absence or human resource contacts, Wilhelm advised.
"Managers must keep in mind that employees with current or past substance abuse conditions are covered to some extent by the Americans with Disabilities Act and may be eligible for accommodations to receive treatment," she said.
"Once the signs of substance abuse are more obvious, such as an employee smelling of alcohol or exhibiting uncoordinated movements and slurred speech, this should be reported to human resources right away," Wilhelm said. "HR may then sit with the employee and his or her manager and express concern over the observed behaviors."
It's never a good idea to accuse an employee directly of being intoxicated or impaired by drugs. "There may be other explanations for the behavior such as a medical condition or side effects from a legally prescribed medication, and the employee should be given the opportunity to provide this information to human resources," Wilhelm adds.
It's important for an employer to foster an open environment where people can talk about substance use without stigma and with the full knowledge that people may still be dealing with COVID-19-related emotional issues.
"Many employers are launching awareness programs around substance use that include broad education, reducing stigma, and how to work with employees and family members who may have substance use struggles," Conforti said. "Also, many employers are looking at providing information, including resources and referrals to mental health professionals, through their EAP and making sure employees are aware of how to access care for themselves or family members."
"Most employers are working on targeted manager training, including annual EAP training on mental health and substance use disorders," Conforti said. "Companies are also creating or updating their toolkits so their managers don't have to diagnose issues but can provide an environment where they know how to provide access to the right resources."
With COVID-19 displacing so many workers over the past several months and with more companies encouraging remote work, how does a manager recognize and handle a potential substance abuse situation with an at-home employee?
"Managers should set clear expectations around remote work," Wilhelm said. "This can include defining standard workdays and hours, reiterating the process for calling out sick or requesting time off, and clearly communicating deadlines and deliverables.
"Managers should stay on top of any problematic behavior—like missing calls or deadlines, or a decline in the quality of the work—that could indicate a condition that is impacting the worker's ability to meet the expectations of the job," Wilhelm added.
The process for addressing substance abuse and other addictions when they impact an employee's work are the same whether they're at the worksite or working remotely.
"The employee may qualify for a leave of absence or accommodation to seek treatment for the condition, and, fortunately, many providers now offer virtual counseling or treatment," Wilhelm said.
One of the best ways to manage addiction in the workplace, especially given that COVID-19 may have thrown many managers off balance, is to have a clear set of rules to follow.
"Clear workplace policies, programs like an EAP and self-help, peer-based programs along with treatment resources and referrals are all great steps to help employers provide support for employees and their family members," Conforti said. "Addiction often impacts not only the addicted individual but the entire family system. Therefore, making sure that your insurance plan does not limit access to care and covers substance use is critical for making sure care is accessible and clinically appropriate."
Brian O'Connell is a freelance writer based in Bucks County, Pa. A former Wall Street trader, he is the author of the books CNBC Creating Wealth and The Career Survival Guide.
On June 5, 2020, the Federal Motor Carrier Safety Administration (FMCSA) granted a three-month waiver from certain pre-employment testing requirements applicable to employers of drivers subject to 49 CFR part 382.
For more details, visit the FMCSA web page https://www.fmcsa.dot.gov/emergency/three-month-waiver-response-economic-consequences-covid-19-public-health-emergency.
The statment can be downloaded directly from here.
As states move to revise marijuana laws, employers and municipalities are revising their pre-employment drug screenings to exclude the presence of tetrahydrocannabinol (THC) in test results.
Most zero-tolerance testing policies aimed at the Schedule I drug were enacted in the 1980s fueled by Nancy Reagan's anti-drug campaign which spawned widespread measures to curb marijuana use. President Ronald Reagan signed the Drug-Free Workplace Act in 1987, which required employers and entities receiving federal assistance to enact staunch, zero-tolerance drug-free workplaces in order to receive grants and federal monies.
Negative public sentiment for cannabis was at an all-time high, but attitudes toward marijuana throughout the past 30 years slowly shifted to accepting the reality of legalization and eventually the relaxation of workplace drug policies.
Paul Armentano, deputy director of the National Organization for the Reform of Marijuana Laws (NORML), explains the change to EHS Today, "Clearly from the outside looking in, it is apparent that there is a trend among lawmakers in certain regions of the country to revisit the issue of pre-employment screening for marijuana. And, it is likely that they are revisiting this issue because the laws around cannabis, and the public adult consumption of cannabis, have changed in many of these jurisdictions."
In early May, New York City declared it unlawful “for an employer, labor organization, employment agency, or agent thereof to require a prospective employee to submit to testing for the presence of any tetrahydrocannabinols or marijuana in such prospective employee’s system as a condition of employment.” The early-May ruling excluded employees and candidates in "safety-sensitive positions," such as police officers, commercial drivers and workers who fall under federal drug testing guidelines.
On May 12, city officials in Rochester, NY. voted to end pre-employment marijuana testing for non-safety sensitive city employees.
East District Councilmember Mary Lupien applauded the effort at the meeting, saying, "This is an important piece of legislation that I think is going to do a lot of good."
Richmond, Va. council members also recently passed a resolution to exclude non-safety sensitive employees and job applicants from marijuana testing.
THC is a psychoactive constituent, which means that a worker's motor skills and cognitive ability could be affected while performing various tasks. In a 2019 National Safety Council (NSC) survey, 81% of employer were "concerned" about the drug having a negative impact on their workforce.
In a response to the survey, Lorraine M. Martin, NSC president and CEO, called for researchers to develop new ways of detecting cannabis impairment, saying, “In order to protect our employees and those around them, we need to acknowledge the impairing effects of cannabis. We urge employers to implement policies stating no amount of cannabis consumption is acceptable for those who work in safety-sensitive positions.”
Although marijuana remains the most commonly identified illicit drug in a workplace screening, that doesn't necessarily mean an employee or candidate is unable to perform their duties. A positive test also does not equate to a worker using while they are on-the-clock either.
"It was one thing to have a blanket policy that said we are not going to hire somebody who has a history of using marijuana use because marijuana use was against the law," Armentano says.
Now that marijuana use is decriminalized or legal in most states, it's harder to justify zero tolerance, blanket policies. He adds, "There needs to be more legitimate reason than that, as to why these individuals ought to be denied employment. When you take the element of criminality out of this equation, there isn't much of a justification left for saying these individuals are not qualified for this particular job. There's certainly no evidence that individuals who use cannabis in their off time are any less qualified for employment, or any more likely to have some sort of accident while in the workplace."
A 2020 review published in the journal Substance Use & Misuse examines whether there is a causal relationship between cannabis use and occupational injuries. Researchers affiliated with the Northern Medical Program, University of British Columbia and the Canadian Institute for Substance Use Research (CISUR) analyzed 16 reviewed studies, concluding, "the current body of evidence does not provide sufficient evidence to support the position that cannabis users are at increased risk of occupational injury."
They add, "further, the study quality assessment suggests significant biases in the extant literature are present due to potential confounding variables, selection of participants, and measurement of exposures and outcomes. Future high-quality evidence will be needed to elucidate the relation between cannabis use and occupational injury."
The road to revising drug testing policies is bound to be filled with obstacles. For post-accident drug testing, it all boils down to liability.
"The reason why post-accident drug testing is done is to try to determine liability," Armentano says. "Was the worker impaired on the job, and thus responsible for the accident, or was the worker unimpaired on the job, and therefore, potentially the employer is liable? Those are the sort of questions that are being asked when there's an accident in the workplace. The reality is most conventional drug testing and urinalysis in particular provide no concrete answers to those questions. So for that reason alone, it behooves employers to try to consider other alternatives."
Employers likely won't move from a blanket policy to complete abolishment of testing just because a state has approved marijuana use for recreation or medicinal purposes. Incremental change is the name of the game.
Armentano comments, "It certainly is probable that during the early stages of these changes, employers are going to exhibit an abundance of caution. They're arguably going to potentially only apply these policies to certain employees, and keep these policies in place for other, more safety-sensitive employees. So just like we've seen overall culturally with gradual changes in the perception of marijuana, we're going to see these gradual changes beginning at the state and local level in the workplace, but they're not going to be all at once."
The Agricultural Improvement Act of 2018, Pub. L. 115-334, (Farm Bill) removed hemp from the definition of marijuana under the Controlled Substances Act. Under the Farm Bill, hemp- derived products containing a concentration of up to 0.3% tetrahydrocannabinol (THC) are not controlled substances. THC is the primary psychoactive component of marijuana. Any product, including “Cannabidiol” (CBD) products, with a concentration of more than 0.3% THC remains classified as marijuana, a Schedule I drug under the Controlled Substances Act.
We have had inquiries about whether the Department of Transportation-regulated safety- sensitive employees can use CBD products. Safety-sensitive employees who are subject to drug testing specified under 49 CFR part 40 (Part 40) include: pilots, school bus drivers, truck drivers, train engineers, transit vehicle operators, aircraft maintenance personnel, fire-armed transit security personnel, ship captains, and pipeline emergency response personnel, among others.
It is important for all employers and safety-sensitive employees to know:
1. The Department of Transportation requires testing for marijuana and not CBD.
2. The labeling of many CBD products may be misleading because the products could contain higher levels of THC than what the product label states. The Food and Drug Administration (FDA) does not currently certify the levels of THC in CBD products, so there is no Federal oversight to ensure that the labels are accurate. The FDA has cautioned the public that: “Consumers should beware purchasing and using any [CBD] products.” The FDA has stated: “It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.”* Also, the FDA has issued several warning letters to companies because their products contained more CBD than indicated on the product label. **i
3. The Department of Transportation’s Drug and Alcohol Testing Regulation, Part 40, does not authorize the use of Schedule I drugs, including marijuana, for any reason. Furthermore, CBD use is not a legitimate medical explanation for a laboratory-confirmed marijuana positive result. Therefore, Medical Review Officers will verify a drug test confirmed at the appropriate cutoffs as positive, even if an employee claims they only used a CBD product.
It remains unacceptable for any safety-sensitive employee subject to the Department of Transportation’s drug testing regulations to use marijuana. Since the use of CBD products could lead to a positive drug test result, Department of Transportation-regulated safety- sensitive employees should exercise caution when considering whether to use CBD products.
The contents of this document do not have the force and effect of law and are not meant to bind the public in any way. This document is intended only to provide clarity to the public regarding existing requirements under the law or agency policies. This policy and compliance notice is not legally binding in its own right and will not be relied upon by the Department as a separate basis for affirmative enforcement action or other administrative penalty. Conformity with this policy and compliance notice is voluntary only and nonconformity will not affect rights and obligations under existing statutes and regulations. Safety-sensitive employees must continue to comply with the underlying regulatory requirements for drug testing, specified at 49 CFR part 40.
February 18, 2020
i* What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD: The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.” https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and- what-were-working-find-out-about-products-containing-cannabis-or-cannabis