Selecting the appropriate DAT menu

March 1, 2010
We welcome Jack Zakowski, PhD, director of scientific affairs and professional relations at Beckman Coulter in Brea, CA, who addresses our questions about drugs-of-abuse testing (DAT).

MLO: If a lab did not currently perform DAT, what
would you recommend in terms of the type(s) of equipment and test menus that
would provide an adequate beginning for drugs-of-abuse testing? Why?

Dr. Zakowski: There are a number of approaches to
establishing a DAT program. A lab director should first identify the source
of all specimens for testing and the purpose of testing. The answers to
these questions will determine the breadth of DAT menu needed. It will also
determine the level of laboratory accreditation required and the appropriate
accrediting agency. Next, in choosing a testing platform, flexibility should
be at the forefront of the lab director's mind. Does the platform have a
relevant menu? Will results be consistent across platforms regardless of
location (in the case of hospital networks)? Will the platform accommodate
workflow? Also of importance is the ability of the assays to provide
appropriate precision, cut-off limits, and their susceptibility to
interferences.

Test menus will vary depending on the type of DAT testing to be provided, for example:

  • emergency department (ED) testing for strictly
    clinical purposes;
  • drug-abuse treatment programs requiring random
    testing and testing of patients in maintenance treatment or short- or
    long-term detoxification treatment;
  • pre-employment or Department of Transportation (DoT)
    screening per the guidelines established by the Substance Abuse and
    Mental Health Services Administration (SAMHSA); and
  • forensic testing for legal purposes, requiring not
    only adherence to chain of custody (CoC) requirements but also stringent
    procedures and processes for ensuring accurate and reliable results as
    mandated by laboratories certified by SAMHSA.

MLO: About one year ago, your company added
oxycodone to its DAT menu, a menu that includes amphetamines, barbiturates,
barbiturates serum tox, benzodiazapine, benzodiazepine serum tox,
cannabinoid, cocaine metabolite, Ecstasy, methadone, methaqualone, opiates,
phencyclidine, propoxyphene and tricyclics serum tox. [We assume you also
offer testing for alcohol, as well.]

How does a company determine what drugs to add to a DAT
menu? Are there statistics about drug use and abuse that you take into
consideration, or are such decisions based on what medical laboratories say
they need?

Dr. Zakowski: Serum ethanol is included in our DAT
menu, for a total of 16 DAT assays on three of our platforms. With a steady
flow of new, more effective drugs coming into use and changes in patterns of
drug abuse, we collaborate often with our customers to identify trends in
drug abuse as we work to find solutions, focusing on the most demanding
trends. We also rely on sources like leading toxicology experts and
regulations published by appropriate government agencies (e.g., SAMHSA,
Center for Substance Abuse Prevention) along with the data gathered from our
customers.

MLO: An abused drug is often thought of as an
illegal one. But DAT menus also cover prescription drugs that may be used
without careful regard to a physician's orders, for example, in the case of
an overdose. Do you have any statistics that differentiate among all
drugs-of-abuse testing as to what percentage covers the misuse of
drugs — both accidental and intentional — compared to the use of illegal
drugs?

Dr. Zakowski: Illegal drug abuse has long been a
recognized issue in society, but recently an increase in the abuse of
prescription medications has become more apparent. A fact sheet on
prescription drug abuse published by the U.S. Drug Enforcement
Administration notes that prescription drug abuse has increased considerably
more than illegal drug use. Over the last six years in the U.S. alone, the
fact sheet states there has been an 80% increase in the abuse of
prescription medication with the misuse of painkillers representing
three-fourths of the overall problem. Some findings show illicit drug use
remains a larger problem than misuse of prescription-type drugs used
non-medically. These findings may change as the population ages and the
pharmacopeia of drugs expands to treat the aches and pains of the
“baby-boomer” generation.

MLO:What do you see on the horizon in terms
of (a) additions of drugs to test menus, (b) types of technology that might
influence equipment design, or (c) more sophisticated ways in which test
samples might be examined? Will there be changes in the way DAT testing is
performed in the future?

Dr. Zakowski: With a steady flow of new prescription
drugs coming into use in the general population and the aggressive
introduction of synthetic drugs for illegal use, the evolution of DAT is
inevitable. This is why we work so closely with industry experts and our
customers to identify drug-abuse trends. Our objective is always to provide
laboratories with the solutions they need to conduct DAT in an effective
and
timely manner. For example, we recognize that most current DAT tests
require urine samples, which are frequently difficult to collect. We
anticipate that the next generation of DAT tests may focus on alternative
sample requirements, like serum or saliva.

MLO: Do different drugs-of-abuse tests get
used in different parts of the U.S. and in other countries?

Dr. Zakowski: Drug abuse is without question a
worldwide problem, yet, it is important to recognize that there are
geographic differences in drug usage patterns and in lab testing needs. The
choice of DATs for use in a particular lab always rests with the laboratory.
One of our fundamental duties, as a leader in clinical chemistry testing, is
to collaborate with customers and drug-abuse experts to identify changing
patterns of drug abuse and innovative testing strategies, as they pertain to
both illicit street drugs and the misuse of legal prescription drugs.

MLO:With the rise of “pain-management”
practices in the U.S., has there been a subsequent rise in drugs-of-abuse
testing? [There was news recently that in Florida, there is a move to have
these clinics monitored via CLIAC rules rather than by SAMHSA which deals
with substance abuse.]

Dr. Zakowski: Many pain-management programs require
periodic testing of their patients. This testing can be both to detect
patients who are misusing or overusing their medications and also to detect
patients who are not taking the prescribed medications but instead funneling
it to the illegal market.

The platforms referred to by Jack Zakowski, PhD, are
Beckman Coulter's UniCel DxC SYNCHRON Clinical Systems, UniCel iclass
Integrated Systems, and the AU.

Signs of substance-abuse impairment in the workplace

Drug abuse among healthcare professionals is about
the same as the general population — between 10% and 15%, according to
the Drug Enforcement Administration, or DEA. But drug abuse among
healthcare workers poses serious risks for patients, so healthcare
workers need to be aware of addiction's symptoms. Some signs to look for
in co-workers include:

  • long, unexplained absences from work area with
    improbable excuses and explanations;
  • frequent, lengthy trips to bathroom or sites where
    drugs are located;
  • insistence on personal administration or delivery of
    drugs to a patient;
  • volunteering to work overtime and being at work when
    not scheduled;
  • increasing unreliability in keeping appointments or
    meeting deadlines;
  • fluctuations in productivity;
  • difficulty in completing simple tasks, in
    concentrating, or in recalling details and instructions;
  • deteriorating personal appearance, as well as poor
    charting and handwriting;
  • mood swings, depression, anxiety, lack of impulse
    control;
  • changing behavior or attitudes in the employee are
    noticed by patients and staff; and
  • becoming increasingly isolated both personally and
    professionally.6
Who is affected?

The No. 1 most expensive addiction in the United
States is alcohol. Drugs made No. 3 on this exclusive list at an
estimated annual cost of $110 billion. Smoking was No. 2; overeating,
No. 4; and gambling, No. 5. The estimated annual cost of alcohol
addiction is $166 billion; the $18 billion spent on alcohol and drug
treatment last year represented 1.3% of all healthcare spending.1

  • Some 15% of about 22 million Americans engaging
    in substance abuse seek treatment.1
  • About 60% of adults know people who have gone to
    work under the influence of alcohol or drugs.2
  • A survey of callers to the national cocaine
    helpline revealed that 75% reported using drugs on the job, 64%
    admitted that drugs adversely affected their job performance; 44%
    sold drugs to other employees; and 18% had stolen from co-workers to
    support a drug habit.3
  • In a study conducted by Cicala, 8% to 12% of
    physicians were estimated to develop a substance-use problem, with
    emergency medicine and anesthesiology the highest-risk specialties.4
  • An investigation of substance use was studied among
    4,438 nurses: 32% of respondents indicated some substance abuse.
    Emergency room nurses were 3.5 times as likely to use substances as
    general-practice or pediatric nurses.5

References

  1. The 5 most expensive addictions.
    http://articles.Moneycentral.msn.com/Investing/Forbes/The5MostExpensiveAddicitions.aspx .
    Accessed February 15, 2010.
  2. elaws-Drug Free Workplace Advisor.
    http://www.dol.gov/elaws/asp/drugfree/benefits.htm . Accessed
    February 15, 2010.
  3. Arkansas Drug-Free Workplace: Facts and Figures
    about Drugs and Alcohol in the Workplace.
    http://lasbdc.valr.edu/drugfree/facts.asp .
    Accessed February 15, 2010.
  4. Cicala RS. Substance abuse among physicians: What
    you need to know. Hospital Physician. 2003;39(7):39-46.
  5. Trinkoff AM, Storr CL. (1998). Substance use
    among nurses: Differences between specialties. Am J Public
    Health.
    1998;88,581-585.
  6. U.S. Dept. of Justice, Drug Enforcement Administration, Office of
    Division Control. Drug Addiction in Health Care Professionals.
    http://www.deadiversion.usdoj.gov/pubs/brochures/drug_hc.htm . Accessed
    February 15, 2010.