Abuse of legal and illicit drugs is taking a high toll on health, patient, and public safety, as well as national resources. As a result, drug and alcohol abuse in the U.S. and worldwide is impacting laboratory testing menus, workflow, and outreach opportunities. Drugs-of-abuse tests available today on automated, random-access systems are helping physicians differentiate heroin from prescribed opiate use and detect chronic alcohol abuse.
Chronic alcohol abuse and patient safety
Alcohol is the most abused drug worldwide.1 In the U.S. alone, annual financial losses due to alcohol-related illnesses, premature deaths, and crimes are estimated at $185 million.2 According to the World Health Organization (WHO), the incidence of illness and premature death resulting from alcohol problems in Europe is the highest in the world.3
In the hospital setting, almost half of all trauma beds are occupied by patients who were injured while under the influence of alcohol.4,5 Chronic alcohol abuse increases risk of anesthesia and postoperative complications:
- Chronic alcohol misuse is more common in surgical patients (e.g., up to 43% in otorhinolaryngological departments) than in psychiatric (30%) or neurological (19%) patients.
- More than 50% of patients with carcinomas of the gastrointestinal tract are chronic alcoholics.
- The rate of morbidity and mortality due to infections, cardiopulmonary insufficiency, or bleeding disorders is two to four times greater in chronic alcoholics.6
Patients may not admit to chronic alcohol abuse due to shame, denial, and social stigma. Alcohol withdrawal in an alcohol-dependent patient and the development of unforeseen delirium tremens can change a normal postoperative course into a life-threatening situation. Severe symptoms can develop within six to 24 hours after the last drink. In addition to the patient risk, treatment becomes more complicated and expensive, and may require intensive-care unit (ICU) treatment.6
Carbohydrate-deficient transferrin (CDT)
EtG in urine and breath-alcohol content (BAC) are markers of recent alcohol intake. In contrast, high consumption of alcohol over longer periods of time induces characteristic changes in the common serum protein transferrin, giving rise to molecular forms that are significant indicators for chronic alcohol abuse. Carbohydrate-deficient transferrin (CDT) is the most specific marker to detect long-term high alcohol consumption.7 CDT can be measured by immunoassay (N Latex CDT), capillary electrophoresis, HPLC, and mass spectrometry.
Running some of these specialized tests requires a skilled technician, along with the use of expensive equipment and costly reagents, and the turnaround time can be long. These limitations have made such tests unsuitable for routine use. N Latex CDT is the only direct nephelometric immunoassay that uses monoclonal antibodies against CDT. This method determines, with high specificity, whether a test subject has elevated levels of CDT in his or her blood, and first results are available in 18 minutes.7
As an objective adjunct to patient questionnaires (such as AUDIT), CDT can provide primary-care physicians with early identification of at-risk and problematic drinkers. Preoperative identification of individuals at risk helps to avoid postoperative complications.
“We run CDT for the university clinic's emergency room, psychiatry, and gastroenterology departments. CDT is fully automated on the BNTM II system, and samples do not require pretreatment,” says Regina Reppin, PhD, Institute for Clinical Chemistry and Pathobiochemistry, University Clinic, Magdeburg, Germany.8
Drugs of abuse and public safety
Outreach opportunities for laboratories outside the hospital include workplace testing and cases where abstinence must be proven to regain driving privileges or restore child custody.
“Three-quarters of the CDT tests we perform are for legal issues, particularly re-granting of driver's licenses that have been suspended for alcohol abuse,” says Jos P. M. Wielders, PhD, Department of Clinical Chemistry, Meander Medical Center, Amersfoort, Netherlands. “CDT concentrations in the blood represent the average intake over two to three weeks, and it takes about two weeks of abstinence to return to a basic level again. One night of excessive drinking is not enough to send CDT values into the critical range.”8
To support public safety, Italy now requires drug screening to apply for a driver's license and to regain driving privileges after suspension.9
“We are a regional reference laboratory that performs specialized forensic testing,” says Dr. Marzia Bernini of the Department of Legal Medicine, University of Study in Brescia, Italy. “The EMIT method is widely used worldwide for the screening of drugs of abuse. Its practicality, the stability of the reagents (liquid and ready to be used), easy automation on routine analyzers, and, above all, how economical it is compared to the other immunometric techniques make this method an obvious choice in the consolidation of laboratories. As our caseload increased over the years, we needed to improve productivity and increase throughput. Our caseload now exceeds 60,000 screening tests per year. We run EMIT reagents on two platforms; the results correlate well between systems. The automated, random-access systems are especially effective for the high-volume routine screening of drug abuse for toxicological/forensic purposes. They meet our need to have analyzers that are fast, have open-channel access, and personalized software.”
With extensive menus available on benchtop random-access systems, and track-based automation on routine chemistry analyzers, scalable options available today can meet the drug screening needs of a laboratory of any size.
Screening for opiates and heroin
Complicating the issue of testing for opiates legitimately prescribed for pain relief is the number of people misusing opioids. A disturbing new trend across the U.S. is the reappearance of heroin. Laboratory professionals need to know that an opiate-screening test detects the presence of opioids but cannot differentiate a positive result caused by heroin use from that of an opioid that has been prescribed for pain relief. Sending out positive opiate screens for confirmation of the presence of opiate versus heroin by gas chromatography/mass spectrometry (GC-MS) can be costly and time-consuming.10
The World Drug Report 2010 notes that “more than 15 million people worldwide consume illicit opiates (opium, morphine, and heroin). The large majority use heroin, the most lethal form. More users die each year from problems related to heroin use, and more are forced to seek treatment for addiction, than for any other illicit drug. Among illicit narcotics, opiates are also the most costly in terms of treatment, medical care and, arguably, drug-related violence. In addition, heroin is the drug most associated with addiction, which brings about a host of acute and chronic health problems, including the transmission of blood-borne diseases such as HIV/AIDS and hepatitis C. In Central Asia, Ukraine and the Russian Federation, injecting opiates is linked to [as much as] 60% to 70% of all HIV infections.”
6-Acetylmorphine: accurate, on-site screening for heroin
The presence of heroin has traditionally been identified by performing an opiate screen and then confirming for 6-acetylmorphine (6-AM) by gas chromatography-mass spectrometry (GC-MS). Heroin quickly metabolizes into 6-AM. As a heroin metabolite, the presence of 6-AM in urine specifically detects the illicit use of heroin. 6-AM is not produced metabolically in humans from either codeine or morphine. A positive 6-AM test also differentiates heroin use from prescription-drug use.11
Laboratories using the 6-AM test now have the ability to directly screen for heroin use. On-site testing combined with data management and reporting:
- eliminates manual, subjective methods
- can improve workflow and efficiency
- can save time and prevent costly transcription errors with instant uploads of test results.
Effective October 1, 2010, the Substance Abuse and Mental Health Services Administration (SAMHSA) enacted new mandatory guidelines that require 6-AM as part of the initial screening for all federally mandated workplace drug-testing specimens.12
Court laboratory experience with 6-AM testing
Though the Cuyahoga County Court of Common Pleas Laboratory in Cleveland, Ohio, is not a SAMHSA lab, Laboratory Manager Ann Snyder, MBA, MT(ASCP) SH, screens for 6-AM. “Statistics are showing heroin use is increasing, and the cost of the drug is evidently going down,” notes Snyder.10
Indeed, on January 13, 2011, a 30-year-old heroin dealer was arrested in North Olmsted, a town of 31,000 near Cleveland. That arrest led agents to discover a multi-state drug distribution network being supplied by a Mexican drug ring.13
The Cuyahoga County Court of Common Pleas Laboratory supports a caseload of 28,000 clients from the criminal justice system, serving drug and municipal courts, parole departments, and juvenile court probation. About 100,000 specimens/year are submitted to the laboratory, which runs on average 400 to 500 specimens per day.
“We began testing for 6-AM by immunoassay in 2002 on specimens that were positive for opiates (cutoff 300 ng/mL),” says Snyder. “About two years ago we observed positive for 6-AM tests in the presence of negative opiate screens. That prompted us to begin testing for 6-AM on all specimens with opiate tests before the SAMHSA guidelines were announced. Bringing the 6-AM test in-house is absolutely economical, because otherwise the only way to identify heroin users is by sending out our positive opioid samples for GC-MS, which is very costly and has a turnaround time of 4 to 5 days.”
Current instrumented, on-site immunoassay methods are accurate, specific, and efficient. One such test, the Siemens Syva EMIT II Plus 6-Acetylmorphine Assay, can deliver results in as little as 11 minutes and has a 98% agreement with GC-MS. With a cutoff of 10 ng/mL, the reagents provide qualitative and semi-quantitative results using a monoclonal antibody to ensure accuracy and specificity.11 With severe criminal penalties at stake for heroin offenders, confidence in results is a key consideration. Syva EMIT technology has been cited as a defensible technology in a Supreme Court ruling.14
As a screening and case management tool, EMIT 6-AM is a convenient, accurate, on-site method for detecting the heroin metabolite in urine, and it meets the SAMHSA guidelines for federal workplace testing.11
Connie Mardis, MEd, is a prolific writer about drug addiction in the United States. She also speaks frequently in her role as Director, Global Marketing Education, at Siemens Healthcare Diagnostics.
References
- Lieber CS. Medical disorders of alcoholism. N Engl J Med. 1995;333:1058-65.
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Strategic Plan 2001-2005.
- http://www.euro.who.int/en/what-we-do/health-topics/disease-prevention/alcohol-use/facts-and-figures.
- Gentilello LM, Donovan DM, Dunn CW, Rivara FP. Alcohol interventions in trauma centers. JAMA. 1995;274:1043-1048.
- Spies C, Neuner B, Neumann T, et al. Intercurrent complications in chronic alcoholics admitted to the intensive care unit following trauma. Intensive Care Med. 1996;22:286-293.
- Spies C, Rommelspacher H. Alcohol withdrawal in the surgical patient: prevention and treatment. Anesth Analg. 1999;88:946-954.
- Delanghe J, et al. Development and multicenter evaluation of the N Latex CDT direct immunonephelometric assay for serum carbohydrate-deficient transferrin. Clin Chem. 2007;53(6):1115-1121.
- Manych M. A simple, reliable blood test helps detect chronic alcohol abuse. Medical Solutions. Spring 2011;39-43.
- http://www.mit.gov.it/mit/site.php?p=normativa&o=vd&id=1&id_cat=&id_dett=0. Accessed January 22, 2012.
- Mardis C. Heroin across America: onsite drug test detects heroin. Courts Today. 2011;9(3):14-18.
- Morjana N, et al. New Emit® II Plus 6-Acetylmorphine Assay on the V-Twin®/Viva-E® Analyzers. Toxichem Krimtech. 2010;77(3)210.
- U.S. Federal Register, 73:228, November 25, 2008.
- Krouse, P. Heroin bust points to drug's growing popularity in Northeast Ohio. Cleveland, OH: The Plain Dealer, January 13, 2011.
- National Treasury Employees Union v, Von Raab, 109 S. Ct. 1384(1989).