Standardized Drug Testing – Beginning of a New Revolution

Drugs especially marijuana, barbiturates, benzodiazepines and even amphetamines were commonly prescribed in the 1960s and 70s. This liberal use of drugs and their prescription to the general population, led to a massive spread of drug misuse and abuse. Therefore, ‘War on Drugs’ was initiated by Ronald Reagan in 1982 and in 1986; he signed a Special Order for the Federal institutions to establish drug testing programs for their employees. Many ‘Standardized Drug Testing’ programs are now being carried out by DOT- Dept. of Transport, DHHS – Dept. of Human Health Services, Nuclear Regulatory Commission, US Coast Guard and other agencies.

Even though a small number of Federal Government employees are covered by standardized testing mechanisms, the DOT program covers a variety of workforce diversity such as truck drivers, contractors, etc. Initially, this program was executed to a smaller workforce segment of the US, it managed to lay foundation to initiate further extensive drug testing programs for local and state governments as well as different private sector institutions. The regime followed by the US military is controlled by DOD but its regulations are set as per the guidelines of DHHS Federal Guidelines.

Until the middle of 20th century, the drug testing at workplaces was outsourced to the laboratories many of which didn’t exercise testing according to the national standards. Mostly, immunoassays were done which caused problems such as false positive results and cross reactions. Decongestants such as pseudoephedrine, ephedrine and phenylpropanolamine caused cross reactions with all amphetamine immunoassays. Moreover, even though that morphine is the targeted drug in a lot of opiate assay tests, it got established quite later that even the normal consumption of poppy seeds in baked items could lead to a positive opiate test. Even though the quantity of morphine in the poppy seeds didn’t result in prominent pharmacological effects, they were significant enough to lead to a positive result with the cutoff being 300mg/mL. The tests used to confirm this result also utilized methods such as GC or TLC which were comparatively quite non specific. Moreover, GC/MS was used qualitatively with lesser criteria focused to guarantee objective verification of the identification of drug.

At around similar time, i.e. the late 20th century, the urine samples which are submitted for drug test didn’t fulfill a standardized criterion which is now fixed by the US legal system. It is important that to yield flawless results, it is essential that the forensic samples are held into the chain of custody. A chain of custody is basically made up of two segments: internal and external. The external chain refers to the documentation of the custody of the urine sample from the point of collection and packaging up to the transport and receiving of sample to the laboratory. The internal chain of custody refers to the movement of urine sample (all or some parts of it) within the laboratory testing procedures and their storage and disposal. A well-organized chain of custody is therefore very essential for a laboratory which tests workplace drug content. This is so because workplace drug test laboratories receive thousands of urine samples daily which imparts great responsibility on the laboratory to ensure that the link between the donor of the urine sample and the test result revealed is crystal clear. Therefore, a well executed chain of custody can make a lot of difference while carrying out the procedures. Figure 1.1 on the following page shows the scheme for standardized drug testing procedures.

The initiative taken by President Reagan made it recognizable that a strong need exists to set national standards and regulations in order to enhance the performance of drug testing laboratories. The DHHS published these standards and made them mandatory for the Federal based workplaces to comply with it. These guidelines published in 1988 but were also revised in 1994, 1998 and 2004 according to the needs of that time. These guidelines are mandatory in Federal offices but are also enforced as a standard for the majority of workplace drug testing in the US. Western Europe has now set its own standards which are made applicable in majority of laboratories based there.

However, the original mandates given by Reagan are only applied for a small part of US government workers. The original HHS guideline is being followed by the US Coast Guard where the US military follows DOD rules. DOT regulations are followed by truck drivers, airline crew and railroad workers. However, due two understanding between DOT and HHS, DOT followers also comply and fulfill the HHS guidelines during testing.

NIDA – National Institute for Drug Abuse, in 1988 initiated a program to generate the NIDA Guidelines. But, in 1992, the responsibility was shifted to SAMSHA – Substance Abuse and Mental Health Services Administration’s Division of Workplace Program (DWP). The DWP is responsible to carry out this program which is now known as NLCP – National Laboratory Certification Program. However, it has outsourced the daily follow ups of the laboratories to the RTI – Research Triangle Institute which now carries out daily follow ups. The team based at RTI which looks after NLCP has forensic scientists and researchers which also control other projects other than NLCP. Therefore, this division of RTI is now known as the Center of Forensic Sciences.

When the HHS Guidelines were written, a lot of toxicologists had debated on the setting up of cut off points i.e. the lower quantifiable limits. They wanted the laboratory to report any quantity of illegal drug that is detected in the test. However, their queries subsided when they came to know that firstly, cut off points eliminate chances of punitive false positive results due to exposure to the drug incidentally. For instance, due to the inhalation of second hand marijuana smoke or intake of poppy seeds in the bakery items could lead to accidental appearance of cocaine in the worker. This is deemed as positive if cut off points are not set for the minimal limit of drug present. Secondly, these cut offs standardize all the laboratories so that it gives fair judgment to individuals who get themselves tested at a laboratory which is 10 to 100 times more sensitive in their results as compared to other laboratories.  Moreover, if a sample has to be re-tested at another laboratory, then it would be handled with equal sensitivity when cut offs are standardized and declared.

Urine is recognized and commonly used as a testing specimen according to HHS Guidelines. Some programs may use hair or oral fluid such as saliva. However, the guidelines signify that immunoassay is compulsory used as the initial screening method with the GC/MS being the confirmatory tests. Other methods such as LC/MS are not recommended for regular testing though they are used for non regulated testing such as oral fluid and hair specimens. The immunoassay techniques are strictly validated and their cutoffs are highly specified. For instance, if any urine specimen yields below 50ng/mL cannabinoids, then no further testing of cannabinoids would be done on that sample. Likewise, if it yields to be positive with the drug above the designated cutoff, then GC/MS would be done to further confirm the findings. Both the assay and GC/MS are conducted used strict mandate and quality control is maintained. The laboratories which are certified are inspected twice a year in order to maintain their standard and satisfactory performance.

The HHS guidelines are deemed as “Gold Standard” in the USA and are followed by many urine drug testing laboratories. Many laboratories perform these tests following the standards because they fear legal action against them if they provide wrong test results. Therefore, other than HHS guidelines, they FUDT – Forensic Urine Drug Testing Program of the CAP – College of American Pathologists is widely accepted. However, the difference between FUDT and NLCP is that the FUDT program identifies critical techniques and regulations used to analyze drug other than NIDA (cannabinoids, opiates, amphetamines, cocaine, and phencyclidine).

The HHS testing guidelines define about 5 drug groups amongst which some specific ones are identified. For instance, group test of opiates only involves codeine, morphine and monoacetylmorphine where as the group test for amphetamines only includes amphetamine and methamphetamine. However, it is also known that other drugs in these groups such as hydromorphone, oxycodone, hydrocodone, MDA, MDMA and other amphetamine analogs are abused commonly but remain unidentified. Moreover, fentanyl, methadone, methyl phenidate, barbiturate and benzodiazepines are also not included in the drug testing. The reason for this is unknown and maybe, beyond the scope of the book. But, it should be known that privacy issues prevent these drugs from being identified. This is so, because, many employers feel that their therapeutic drug doses shouldn’t be exposed in front of their employee. However, this concern is mainly political as many agencies use non-regulated programs to identify drugs which are beyond the scope of regulated programs.

It is well known that the program mainly targets to curb down illegal drug trafficking particularly of cocaine, heroin and cannabis. Therefore, these programs reduce illegal drug use amongst employees. When an employee is tested positive, their employer helps them via assistance programs so that the employee can re-habilitate and the employer can simultaneously, retain their valuable employee. The Americans with Disabilities Act (ADA) in 1990 was given out to protect such employees who have drug abuse issues. They are considered to have a medical problem and this Act prevents the employer to question their employees about it. However, ADA allows the employers to test their employees for illegal drug usage via urine tests as it doesn’t fit into the domain of medical tests.

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