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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