Transcript an oral fluid test

Trust but Verify:
The Role of
Objective Data in a
Clinical Setting
A Presentation
by John Steinberg,
MD, Internal
Medicine,
Addiction
Medicine, ABAM
Certified
The Bergand
Group
John Steinberg, MD
• Dr. John R. Steinberg is a native of Baltimore, Maryland, who
graduated from the McDonogh School as a National Merit Honors
Finalist. He received his undergraduate degree in Biochemistry from
Michigan State University with High Honors and was elected a
member of Phi Beta Kappa.
• After postgraduate work in Biochemistry, Dr. Steinberg received his
M.D. from the University of Maryland School of Medicine and
completed a residency in Internal Medicine at the Greater Baltimore
Medical Center. He was certified as an addiction medicine specialist
by ASAM in 1987 and became ABAM certified in 2010. He served
as president of the Maryland Chapter of ASAM from 1990 through
2005.
• Dr. Steinberg maintains a practice in Addiction Medicine, General
Internal medicine, and Adult Psychiatry.
2
Substance Abuse Trends Are Going Up
Current illicit drug use in America
rose from:
8% in 2008
to
8.9% in 2010.
Source: 2010 SAMHSA’s National Survey on Drug Use and Health
3
Marijuana Use Continues to Lead the Way
• Current use of marijuana was one of the prime factors in
the overall rise in illicit drug use. In 2010, 17.4 million
Americans were current users of marijuana – compared
to 14.4 million in 2007.
• This represents an increase in the rate of current
marijuana use in the population 12 and older from
5.8-percent in 2007 to 6.9-percent in 2010.
Source: 2010 SAMHSA’s National Survey on Drug Use and Health
4
Young Adults Are At the Center of
the Increase
• Another disturbing trend is the continuing rise in the rate of
current illicit drug use among young adults aged 18 to 25 -from 19.6-percent in 2008 to 21.2-percent in 2009 and
21.5-percent in 2010.
• This increase was also driven in large part by a rise in the
rate of current marijuana use among this population.
Source: 2010 SAMHSA’s National Survey on Drug Use and Health
5
Prescription Drug Use Is A Big Part of
the Problem
• Among the survey’s other noteworthy findings was that the
majority (55-percent) of persons aged 12 and older who
had used prescription pain relievers non-medically in the
past 12 months received them from a friend or relative for
free.
• Only 4.4-percent of those misusing pain relievers in the
past year reported getting their supply from a drug dealer
and 0.4-percent bought it on the Internet.
Source: 2010 SAMHSA’s National Survey on Drug Use and Health
6
Rx Use, Abuse and Misuse
• Definition of non-medical use of Rx drugs
– Use of a drug not prescribed to you
– Use of the drug only for the experience of feeling it caused
• Motives for Rx diversion
–
–
–
–
–
Guaranteed strength/safety
Oral use (no risk of HIV, Hep B or C)
Obtained from legal sources
Often paid for by third party (insurance company)
Used/sold/bartered for illicit drugs
7
Prevalence of Rx Misuse, Abuse and Addiction
Prevalence of Rx misuse, abuse and addiction by percent of population
Total Rx Population
Rx Misuse 40%
Rx Abuse 20%
Rx Addiction 2%-5%
Source – Webster LR, Webster RM. Pain Med. 2005;6(6):432-442.
8
Selected Drug Prescriptions in US – 2007
Rank of Selected Prescription Drugs based on US Prescription Volume - 2007
Drug
Hydrocodone
Alprazolam
Oxycodone
Lorazepam
Clonazepam
Diazepam
Temazepam
Amphetamine Salt Combo
Fentanyl Transdermal
Codeine
Butalbital
Methadone
Phenobarbital
Propxyphene
Rank
1
10
21
30
33
62
108
158
167
173
177
203
245
688
Source – Verispan, LLC: Vector One®: National Extracted 8.15.08,
File: VONA2008-1191 top drugs dispensed
9
Some Interesting Facts
• Treatment of chronic pain is surging in the US
• In 2000, 174 million opioids were prescribed. By 2009 that figure had
soared to 254 million
• Non-medical use of Rx opioids is a significant societal issue
–
–
–
–
–
35 million people (>10% of US population) have used in their lifetime
>300,000 emergency room visits annually
13,000 fatal overdoses
85,000 admissions annually to drug treatment centers
Rx analgesic overdose is the leading cause of death in 10 states
• If expand ED visits to other pain killers and sedatives in addition to
opioids, over 1 million people were seen in 2008. This is as many
people that present to the ED for illicit drugs
Source – SAMHSA 2009, Results from the 2008 National Survey on Drug Use and Health: National Findings, MSDHU Series H-36
CDC. Emergency Department Visits Involving Nonmedical Use of Selcted Prescription Drugs-US 2004-2008; MMWR 59(23);705-709.
White, et al. Societal Costs of Prescription Opioid Abuse, Dependence, and Misuse in the United States; Pain Med. 2011.
Office of the Army Surgeon General. Pain Management Task Force, Final Report, May 2010.
10
ED Visits 2004 – 2009 by Drug Categories
Drug category and selected drugs ED visits 2004 - 2009
Drug
2004
2005
2006
2007
2008
Opiates/Opioids
172,726 217,594 247,669 286,521 366,815
Opiates/opioids, unspecified
31,846
52,670
50,978
52,997
66,585
Narcotic pain medications
144,644 168,376 201,280 237,143 305,885
Buprenorphine
N/A
N/A
4,440
7,136
12,544
Codeine
7,171
6,180
6,928
5,648
8,235
Fentanyl
9,823
11,211
16,012
15,947
20,179
Hydrocodone
39,844
47,192
57,550
65,734
89,051
Hydromorphone
3,385
4,714
6,780
9,497
12,142
Meperidine
782
383
1,440
997
1,435
Methadone
36,806
42,684
45,130
53,950
63,629
Oxycodone
41,701
52,943
64,888
76,587 105,214
Propoxyphene
6,744
7,648
6,220
7,401
13,364
2009
416,458
84,144
342,628
14,266
7,958
20,945
86,258
14,337
1,350
63,031
148,449
9,526
Source – SAMHSA 2009, DAWN National Estimates of Drug-Related ED Visits; August 2011
11
Buprenorphine Misuse and Abuse
• The Maryland Adult OPUS findings, combined with national
indicators of increased buprenorphine availability, diversion, and
nonmedical use, suggest that there may be an epidemic of
buprenorphine misuse emerging across the U.S.
• Buprenorphine is now more likely than methadone to be found in law
enforcement drug seizures that are submitted to and analyzed by
forensic laboratories across the country, according to data from the
National Forensic Laboratory Information System (NFLIS).
• Regardless of whether diverted buprenorphine is being used
nonmedically to self-treat opiate addiction or to get high,
unsupervised use of diverted buprenorphine places users at serious
risk for potential adverse health effects, especially when taken in
combination with other opioids or with depressants such as
sedatives, tranquilizers, or alcohol.
Source – CESAR Fax, Center for Substance Abuse, March 2012, April 2012
12
Use, Abuse & Addiction
• Many people can use legally-prescribed and obtained drugs without
crossing the line into abuse and addiction.
• But it’s usually a fine line between use, abuse and addiction and not
everyone can tell when they’ve crossed that line.
• Here are a few signs to look for:
– Missing or being frequently be late for work, school or other
obligations
– Job performance falters and over time becomes intolerable for the
employer
– Neglecting social or family obligations
– The ability to stop using becomes more difficult
– A voluntary choice becomes a psychological (and sometimes
physical) need
13
It’s Serious When…
• Flunking classes at school
• Taking risks such as driving under the influence
• Stealing from others to support drug habit
• Getting arrested
• Neglecting children
• Domestic violence
• Losing otherwise good friends
• Termination at work
14
5 Questions to Ask
1. Are you using more drugs now to get the same results you used to
get with smaller amounts?
2. When you go too long without drugs do you begin to experience
symptoms such as nausea, restlessness, insomnia, depression,
sweating, shaking, and anxiety?
3. Do you feel powerless to stop using drugs?
4. How much time do you spend thinking about drugs, planning how
to get them, and recovering from the drug’s effects?
5. What things you to give you pleasure that you no longer do?
(Sports, hobbies, relationships, socializing, studying, etc.)
15
Presenting Results to the patient
•
Asking the patient before presenting
•
Breaking through denial for patients that test positive
16
Drug Testing - In the Beginning…
Urinalysis has been the most common drug testing
method for nearly 30 years. The process consists of…
a. Collection
b. Laboratory analysis
c. GC/MS confirmation
d. Medical Review Officer verification
e. Results reporting
17
Pros of Urine Drug Testing
• Commonly used
• Widely accepted
• Legal
• Legally defensible
• Accurate
• Flexible (available as a lab-based or rapid result test)
18
Cons of Urine Drug Testing
• Well, it’s urine
• Invasive
• Subject to adulteration
• Costly
• Inconvenient
• Not good at detecting very recent use
19
Then Came Oral Fluid Testing…
• Well, it’s not urine
• Easy to administer internally
• Virtually impossible to adulterate
• Legal in most jurisdictions
• Legally defensible
• Rapidly increasing in popularity
20
Oral Fluid Testing…
• Drugs are detected immediately after use
• “Under the influence” indicator
• Less invasive collection process
• Comparable to blood
• Science continues to progress and get better
• Flexible… sample can be collected any time, anywhere
• There are FDA cleared oral fluid collection and testing
products
Source: Myths & Facts About Oral Fluid Drug Testing, On File OraSure Technologies, 3/2011
21
Is Lab-Based Oral Fluid Testing Accurate?
The results of lab-based oral fluid testing may have greater
relevance to understanding the effects of drug abuse and
assessing an individual’s behavior than the results from
urine testing. The presence of drugs in oral fluid is usually
related to the amount of drugs in the bloodstream at the
time of the sample collection.
• Oral Fluid provides a blood equivalent result
• Oral Fluid tests for the parent drug and not just a metabolite, making
it possible to detect recent drug use more accurately than urine, which
typically detects only metabolites
• Advances in oral fluid testing and collection technology are making it
possible to more accurately quantify drug test results
Source:E.J. Cone. Oral fluid testing: New technology enables drug testing without embarrassment. CDA Journal. 34: 311-315 (2006).
22
Accuracy
How to know if a product is accurate…
• Independent, empirical data (publications)
• FDA cleared
• History of satisfied customers (ask for referrals)
• Your own internal research
• Put the package insert information to the test
• Know who you’re doing business with
23
Detection Times
Drug transfer to oral fluid from blood occurs as long as the
drug is in the bloodstream, thus detection times start within
minutes of ingestion and continue for as long as the drug
remains in the bloodstream. Drug detection by lab-based
oral fluid testing is as effective as urine testing over a
comparable time period.
1. Window of detection is affected by many factors regardless of the
specimen being tested
2. Every drug has its own unique window of detection
3. Each specimen type has its own unique ability to reveal the presence
of a particular drug
Source:E.J. Cone. Oral fluid testing: New technology enables drug testing without embarrassment. CDA Journal. 34: 311-315 (2006).
24
WOD for Various Matrices
Source:E.J. Cone. Oral fluid testing: New technology enables drug testing without embarrassment. CDA Journal. 34: 311-315 (2006).
25
Is the Window of Detection Too Short?
Generally, lab-based oral fluid and urine provide comparable
positivity rates.
Oral fluid can pick up drugs early on which urine will miss;
urine can sometimes pick up positive results longer which
oral fluid will miss… but on balance, cut-off levels developed
for oral fluid produce similar positive rates when compared
to urine.
Source:E.J. Cone. Oral fluid testing: New technology enables drug testing without embarrassment. CDA Journal. 34: 311-315 (2006).
26
Is the Window of Detection Too Short?
Source:R.H.B. Sample, L.B. Abbott, B.A. Brunelli, R.E. Clouette, T.D. Johnson, R.G. Predescu, and B.J. Rowland. Positive prevalence
rates in drug tests for drugs of abuse in oral-fluid and urine. Society of Forensic Toxicologists (SOFT) Annual Meeting (2010).
27
Cheating
• Urine tests are susceptible to drug test cheating
• Oral fluid is very difficult to adulterate
• Collection takes place in the presence of both the donor
and the administrator of the test
• Typical cheating methods such as switching samples or
adding something to a sample are virtually impossible to
successfully pull off
• A search of the Internet will find thousands of hits for
cheating on a urine drug test… only a handful for oral
fluid testing
28
Is Oral Fluid Testing Just as Susceptible to Cheating
as Urine Testing?
• Oral fluid is very difficult to adulterate
• Oral fluid collections take place in the presence of both the
donor and the administrator of the test
• Typical cheating methods such as switching samples or
adding something to a sample are virtually impossible to
successfully pull off… even if a product existed that could
mask the presence of drugs in saliva
• A search of the Internet will find thousands of hits for
cheating on a urine drug test… only a handful for oral fluid
testing
29
Advice for cheating an oral fluid drug test…
One of my favorite websites for oral fluid drug test cheating is
wikihow.com/pass-a-drug-test. Quoting directly from the website:
“Try to avoid the test. If one is being tested and has used in the past 3
days you will need to overcome the saliva collection. To do this you will
have to avoid submitting saliva and perform the steps requested of you by
the instructor.”
Another offers this advice:
“To pass this [an oral fluid test] you should always know the detection
time of the drug you have taken. Marijuana can be detected via saliva
drug testing from an hour after ingestion up to 24 hours depending on
use. Between these periods of time, you must avoid being screened or
you will surely test positive.”
30
Cheaters Love Urine Testing?
• Drug test cheating is a major concern because urine
testing is particularly susceptible to adulteration, tampering
and substitution.
• Efforts to combat drug test cheating in urine add to the
cost of drug testing, infringe further upon the privacy of
donors, and can further reduce the efficiency of drug
testing thus reducing the ROI hoped for from drug testing.
• Lab-based oral fluid testing virtually eliminates concerns
about drug test cheating. Every oral fluid collection can be
observed, thus making it impossible for someone to
tamper with the specimen.
31
Dignity
The testing process protects the dignity and privacy of
the donor.
• No urine, no bathroom… no humiliating observed
collections, no gender match-up issues, no threats of drug
test cheating
• Donor and administrator observe the collection together
• Specimen never leaves the donor’s sight
• Embarrassing shy bladder issues are eliminated
• There’s virtually no way to cheat
32
Oral Fluid Testing
Advantages of oral fluid testing:
– Flexible….sample can be collected anytime, anywhere
– Lab based oral fluid testing is legal in 48 states
– Legally defensible as technology is widely considered
reliable
– Scientifically accurate
– A more accurate method to measure “recent” use
– Easy to administer and often preferred by those who
administer tests
33
Oral Fluid Testing
Advantages of oral fluid testing:
– Gender collector issues are eliminated
– Observed collections can occur with every test creating
trust in the process
– Collection process is not embarrassing for the donor
– Eliminates the need for the myriad precautions needed
with urine testing
– Eliminates time-costing “shy bladder” issues
– Eliminates the “yuck” factor commonly associated with
urine testing
– Virtually adulteration proof
34
OraSure… Intercept ®
• Intercept® Oral Fluid Collection Device
• Oral Fluid Drug Assays Used in Laboratory
35
Benefits of OraSure Technologies’ Intercept®
• 10+ Years Proven Performance
• More than 15 million samples tested with a proven track record of reliability,
accuracy and quality service.
• #1 recognized brand name for oral fluid drug testing.
• Scientifically Proven
• The ONLY oral fluid collection device that is FDA-cleared for 9 assays.
• Legally Proven
• Intercept has been upheld in multiple court cases in both criminal justice and
family courts.
• Direct Observed Collections
• Very difficult to cheat on the result.
• No third party collection site.
• Quick and Convenient
• The oral fluid collection takes no more than 5 minutes to complete, and it also
eliminates the ‘shy bladder’ challenge.
36
How can Oral Fluid testing fit into your practice?
• open discussion
37
HIV and HCV
38
HIV Infections
Approximately 1 in 5 people who are HIV+ do not know it, and they cause over
50% of new infections
~21% Unaware
of Infection
~50-70% of New
Infections
~79% Aware of
Infection
~30-50% of New
Infections
People living with HIV/AIDS ~1.1 million
New infections per year ~56,300
AMA Jour of Ethics, Dec 2009, Vol 11, Num 12: 974-979
39
Risk-based HIV Screening
• Offer HIV test to anyone with following HIV risk
characteristics within last 12 months:
–
–
–
–
–
–
Injection drug use (IDU)
Men who have sex with men (MSM)
Sex with an IDU, MSM, or HIV-infected partner
Multiple sexual partners
Exchange of sex for money, drugs, or other goods
Diagnosis of another sexually transmitted infection (STI)
• Recent studies in jail settings indicate that large
proportion of HIV-infected inmates did not report risk
factors
40
Clinical Indicators for HIV Screening
• Pregnancy
• Diagnosis or history of sexually or parenterally transmitted
infections (e.g., HBV or HCV, syphilis, genital herpes,
gonorrhea, chlamydia, trichomonas infection)
• MTB infection or active TB
• Track marks indicative of illicit drug injection
• Signs or symptoms suggestive of HIV infection or acute
retroviral syndrome
41
Clinical screening
• Hepatitis C / Hepatitis B infection may indicate potentially
risky blood-borne or sexual behaviors
– 16-41% of prison inmates have serologic evidence of Hepatitis C
infection
– 13-47% have markers for Hepatitis B infection
• Evidence shows that evidence of sexually transmitted
infections (STI’s) increases the likelihood of acquiring and
transmitting HIV infection
• There is a strong association between risky sexual
behaviors and the use of illicit drugs (especially injection
drugs, stimulants, and ecstasy) and alcohol abuse which
leads to an increased risk for HIV infection
42
Hepatitis C (HCV) Facts
• There are 3 million people in the US infected with HCV
who are unaware and 75-85% of them are chronically
infected.
• Chronic HCV places infected persons at risk for
complications (e.g. cirrhosis and hepatocellular
carcinoma (HCC)) that can take decades to develop.
Approximately 50% of HCC is caused by HCV
infection.
• Today, risks for HCV transmission are primarily
associated with exposure to contaminated blood
CDC, Recommendations for Identification of Chronic Hepatitis C Virus Infection Among Persons Born During 1945-1965, MMWR, Vol. 61, No. 4, August 17, 2012, pp. 1-32.
43
Drug Use as an HCV Risk Factor
• Injection drug use (IDU) was the most
commonly reported risk factor for HCV
infection in the CDC data from 19822006.
• 72.1% of IDU patients had been in a
substance abuse or drug treatment
program and/or incarcerated.
• The study noted that self-reporting of IDU
may be under-reported as many people
may not be willing to admit to the
behavior.
• HIV and HCV prevalence is increasing as
a consequence of opioid dependence and
high-risk IDU behaviors, including sharing
of contaminated syringes and unprotected
sexual contact.
Williams, et al, Incident and Transmission Patterns of Acute Hepatitis C in the United States, 1982-2006, Archives of Internal Medicine, No. 3, Feb. 14, 2011, pp. 242-248.
McCance-Katz, E., Treatment of Opioid Dependence and Coinfection with HIV and Hepatitis C Virus in Opioid-Dependent Patients: The Importance of Drug Interactions
between Opioids and Antiretroviral Agents, Clinical Infectious Disease, 41, (Suppl 1), 2005, S89-95.
44
HCV Testing Guidelines
• The original CDC guidelines outlined routine testing for
persons at risk for HCV infection. MMWR 1998;47 (No.
RR-19)
– Routine HCV testing is recommended for persons who ever
injected illegal drugs, including those who injected once or a
few times many years ago and do not consider themselves as
drug users.
• In 2012, the CDC augmented these recommendations
to include baby boomer testing. MMWR 2012;61 (No.
RR-4) Adults born during 1945-1965 should receive
one-time testing for HCV without prior ascertainment of
HCV risk.
CDC, Recommendations for Identification of Chronic Hepatitis C Virus Infection Among Persons Born During 1945-1965, MMWR, Vol. 61, No. 4, August 17, 2012, pp. 1-32
CDC, Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease. MMWR, Vol. 47 RR-19, Oct. 16, 1998, pp-1-40..
45
Treatment of Hepatitis C in IDUs
• Data supports that HCV-infected IDUs with chronic
HCV infection can be treated successfully if they are
closely supervised by physicians specialized in both
hepatology and addiction medicine.
• In the past because of poor drug treatment
compliance, IDUs were only treated for HCV after 6 to
12 months of drug-free health.
McCance-Katz, E.,Treatment of Opioid Dependence and Coinfection with HIV and Hepatitis C Virus in Opioid-Dependent Patients: The Importance of Drug
Interactions between Opioids and Antiretroviral Agents, Clinical Infectious Disease, 41, (Suppl 1), 2005, S89-95.
Backmund, et al, Treatment of Hepatitis C Infection in Injection Drug Users, Hepatology, Vol. 34, No. 1, July 2001, pp. 188-193. ©2012 OraSure Technologies, Inc.
OraQuick® HCV is a registered trademark of OraSure Technologies, Inc. Item# HCV0111 (Rev. 10/12)
46
HIV/HCV Testing Program Suggestions
• Provide HIV/HCV information at intake and throughout
program participation
– Who has access to information
– HIV/HCV testing policy
– Medical care for HIV+ individuals
• Provide brochures about a variety of medical conditions so
that accessing HIV/HCV information is comfortable
• Conduct HIV/HCV testing as part of routine services
• Record delivery of results in medical record
• Keep records in locked, secure location
47
Testing Algorithm
Screen
EIA – blood / oral
Rapid – blood / oral
Confirm
Western Blot
CD4
Viral Load
48
Treat
Providing Test Results
• Review state laws
• Provide results in a confidential manner, clearly explaining
test results
• Negative results – can be provided in person or through
confidential written notification
• Preliminary Positive results – notify only in person in
private setting
• Prevention counseling – not mandated but useful
– If negative – how to stay negative
– If positive – how to prevent infection
49
Linkage to Care
• HIV/HCV prevention counseling
• Referral for mental health support as indicated
• Medical evaluation including staging of HIV/HCV infection and
diagnosis of co-morbidities and opportunistic infections
• Referral to an HIV/HCV provider or specialist depending on the
provider’s experience, the stage of disease, and complexity of
medical issues
• Expedited care may be necessary for special clinical
circumstances including acute infection, infection with an acute
opportunistic infection, and infection during pregnancy.
• Other needs:
– Substance / alcohol abuse prevention
– Adherence to HAART
50
®
OraQuick ADVANCE Rapid HIV 1/2 Antibody Test
• Simple
– Rapid HIV-1/2 antibody testing with oral fluid
collection
– Delivers results in 20 minutes
• Accurate
– Results with >99% sensitivity and specificity
across all specimen types
• Versatile
– Testing platform suitable for both clinical and
non-clinical settings using several specimen
types
• Improves HIV test acceptance and results
delivery
51
®
OraQuick Rapid HCV Antibody Test
• Deliver rapid results and identify more HCV+
individuals with OraQuick® HCV
• Rapid Results
– Point-of-care testing results in 20 minutes
• Lab Accuracy
– Greater than 98% accurate
• Ease of Use
– CLIA-waived
– Outreach to at-risk populations
52
Wrap Up and Q&A
53