Drug Testing of Body Fluids in the 21st Century

Although the exact size of the drug-testing market in the United States is not known, most industry experts estimate it to be over 120 million tests annually and increasing. This estimate includes criminal justice, workplace testing, emergency medicine, and the newest area of drug testing—schools.

5.1. Criminal Justice

The largest segment of the drug-testing market, criminal justice, is divided into five areas: (1) drug courts, (2) corrections (probation/parole), (3) drug treatment programs, (4) driving under the influence of drugs (DUID), and (5) correctional facilities. Of the five areas, the largest volume of testing occurs in drug courts, drug treatment programs, and corrections.

5.1.1. Drug Courts

Drug courts are the fastest growing area of the criminal justice market. The drug court system (see Chapter 15) has 1093 courts nationally and will continue to grow with the addition of dozens of new courts each year (7). Each program participant is tested monthly, and in some cases weekly, for illicit drugs. In each drug court, the judge usually sets the policies for drug testing (i.e., determining which test will be used, how positive results will be administered, and whether positive screening results will be confirmed). In most courts the positives are not confirmed.

5.1.2. Corrections

It is estimated that 4.8 million adults are under supervision of the courts for either probation or parole reasons (8). The National Survey on Drug Use and Health reported that 28% of these adults reported illicit drug usage in 2002. Sample collection and testing is usually conducted during periodic visits with the parole or probation officers. Because most of these programs are funded by the state or county, budgetary resources are limited for testing. Many parole officers would prefer to use on-site test devices because immediate results are more effective if they need to take the individual into custody. For budgetary reasons, they are forced either to send samples to laboratories for screening (because these lab results are, in most cases, less expensive than using the on-site test device) or, when funds are no longer available, to simply discard the sample. It should also be noted that, in many cases, nonnegative test results may not be confirmed and are treated as positives by the probation or parole program.

5.1.3. Drug Treatment Programs

The drug treatment programs have not changed much since their inception in the 1970s. They continue to dispense methadone, provide counseling, and conduct periodic drug testing. Testing is done weekly. Because the turnaround time for results is not critical, samples are usually sent to reference labs for screening. Confirmation of nonnegative results is usually done; however, there are few punitive results for a positive other than a loss of methadone take-home privileges, unless the methadone patient is assigned to the program by the criminal justice system. In this case, their freedom or rights may be revoked by the courts.

5.2. Workplace

The second largest but most developed segment of the drug-testing market is workplace testing. According to HHS, there are estimated to be 16.6 million illicit drug users over 18 yr of age; of these adults, 12.4 million (74.6%) were employed either full or part time (8). Over half of these employed adults work full time. Currently, 67% of all major US corporations have drug-testing policies. Industry experts have estimated that approx 40 million workplace drug tests are conducted annually. Drug testing in the workplace is divided into two areas: (1) government-mandated drug testing and (2) nonregulated employers or private sector. Of the total, approx 7 million tests are government-mandated tests. The remaining 33 million tests in the private sector are primarily pre-employment tests of new hires to assess their use of illicit drugs. The volume of pre-employment testing is usually found to be in direct correlation with the health of the economy; during a soft economic period, the amount of pre-employment testing will decline as a result of decreased hiring by employers.

5.2.1. Workplace Testing Process

The typical process for a drug screen starts with the employer, who is either operating in a regulated industry, such as transportation, or has made a corporate commitment to provide a drug-free work environment for its employees. The demand for drug-free policies is driven by two key factors: (1) the cost and liability of an unsafe workplace, and (2) federally mandated drug testing of employees in certain safety-sensitive jobs—most notably, the transportation and nuclear industries. Demand in this segment will continue to grow as a result of increased awareness, program effectiveness measures, and policy in government segments.

There are five primary types of drug tests performed in the workplace:

1. Pre-employment

2. Random selection

3. Post-accident

4. Reasonable suspicion/cause

5. Return to duty/follow-up

5.2.2. Collection

All drug tests start with the collection of the sample. For regulated testing programs, the collector must be certified by HHS. The type of specimen collected is determined by the type of test being requested (e.g., a hair sample can be collected only for pre-employment, random selection, or return to duty/follow-up purposes). A minimum quantity must be collected in a manner as outlined by the mandatory guidelines. The sample also may be tested on-site with an appropriate FDA-approved test device, or it may be packaged in an approved sealed shipping container along with the necessary chain-of-custody documents and forwarded to an HHS-certified laboratory for testing. Although most testing programs dictate that urine samples must be collected and sent to an approved lab for screening and confirmation, the emergence of alternate test matrices devices have allowed employers to utilize tools that are less invasive to the privacy of their employees, such as oral fluid. The availability of POCT devices allows the employer to better utilize the employee's time by conducting the drug test on-site, thus minimizing time away from the job by the employee, and possibly the supervisor. A complete description of the collection procedure used to collect each type of specimen can be found in the HHS Specimen Collection Handbook for Federal Workplace Drug Testing Programs. The handbook can be found at www.SAMHSA.gov.

5.2.3. Laboratory

Each HHS-certified laboratory has to meet the standards of the National Laboratory Certification Program (NLCP). To meet these qualifications, the laboratory must pass three consecutive proficiency sample tests, pass an on-site inspection, undergo maintenance inspections twice a year, and continue to pass proficiency sample tests each quarter. When the employee's sample arrives at the laboratory, an initial immunoassay test is conducted to determine the true negatives. In addition, specimen validity (adulteration) tests are conducted on all samples to validate the integrity of the sample. Tests may include creatinine, specific gravity, pH, oxidizing agents, and surfactants. Samples testing nonnegative for parent or drug metabolites are retested for confirmation using a procedure that combines chromatographic separation methods with mass spectrometric identification (gas chromatography-mass spectrometry [GC-MS]; see Chapter 3).

5.2.4. The Medical Review Officer

Before confirmed positive results can be reported to the employer, the results must be reviewed by a medical review officer (MRO). A certified MRO must be a licensed physician with training in the collection, chain of custody, interpretation of test results, and federal workplace regulations policies. After complete review of the collection process, drug testing, and adulteration test results, the MRO will report his or her findings to the employer. Only with the MRO review are the results certified as positive for the drug in question.

5.2.5. The Third-Party Administrator

In many cases there is another party involved in the drug-testing process. This individual or organization is known as a third-party administrator (TPA). The employer may contract with the TPA to manage the entire drug-testing process. TPAs can arrange for the collection, shipment to a certified laboratory, and review by an MRO. If on-site tests are requested, they often provide the collector and test materials for the on-site test. In some cases, the TPA may also provide MRO and laboratory services as well.

5.3. Emergency Medicine

The emergency testing field is relatively small and currently estimated at 2.5 million tests annually. In this kind of situation, speed and proximity of obtaining results for the tests are of prime importance. Urine or blood samples are usually collected at the emergency center and the testing is done in a clinical laboratory. The objective of testing in this area is focused on determining what class of drugs has been ingested and approximately what quantities are present. With these results, an effective antidotal treatment can be formulated. Confirmation of test results is not done in most cases.

5.4. Schools

The emerging arena for drug testing is found in public and private schools. In June 2002, the US Supreme Court ruled that random drug tests could be conducted on all middle and high school students participating in competitive extracurricular activities (9). A national survey titled Monitoring the Future estimated in 2001 that more than half of all students had used illicit drugs by the time they had finished high school (10). Testing in this new field has been slow to develop. With opposition coming from the American Civil Liberties Union (ACLU) and parents, school authorities have been cautious in the development of programs to stem drug abuse in schools. School districts that have instituted drug testing have carefully written policies and procedures that ensure close communication with parents and follow many of the procedures outlined in SAMHSA's mandatory guidelines for the workplace.

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