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Millennium Laboratories Announces Five Drug Screening Tests to Help Pain Physicians with Therapeutic Patient Care
Greater sensitivity, accuracy and specificity with Millennium’s new LC-MS/MS assays can detect and identify drug abuse and diversion.
San Diego, CA -- November 11, 2009 -- Millennium Laboratories, a leading provider of therapeutic drug monitoring and education to physicians and staff treating chronic pain patients, announced today the company’s development and validation of a clinical quantitative assay for the new drug tapentadol (Nucynta™) by liquid chromatography/tandem mass spectrometry (LC-MS/MS). In addition, the company now offers drug screening tests for heroin metabolite 6-Monoacetylmorphine, alcohol biomarkers ethyl glucuronide (EtG) and ethyl sulfate (EtS), and meperidine (Demerol®).
Nucynta is the first new centrally-acting analgesic approved in the United States in 25 years. It is considered to have the potency of morphine with reduced side effects. The drug's presence or absence in a patient can now be detected by LC-MS/MS technology, providing a tool to pain physicians for optimal prescribing.
National pain management expert Dr. Joseph Shurman, Chairman of Pain Management at Scripps Memorial Hospital, La Jolla, California, commented, "With new opioids like tapentadol being introduced, pain physicians need to avail themselves of the latest cutting-edge technology for routine drug screening of their patients. The DEA has mandated that physicians must do their best to demonstrate that their patients are compliant, that they are taking what they are prescribed and are not diverting the drugs. For the health of the patient and for the safety of the patient and the physician’s practice, fast and accurate drug screening results are critical."
6-Monoacetylmorphine (6-MAM, heroin metabolite), has been added to Millennium Laboratories’ offering due to the increase in the US population’s use of heroin. Due to the epidemic of non-medical use of Oxycontin®, heroin use has increased dramatically even though it has no medical utility. Oxycontin can be powerfully addictive because the body quickly develops a tolerance to it. Oxycontin abusers soon gravitate to heroin for its similar high but much lower price tag. Recent research has shown that 6-MAM can be present in urine when morphine, the traditional metabolite looked for in the urine screening process, is absent. By adding the 6-MAM assay, a higher percentage of heroin users can be detected.
Alcohol biomarkers ethyl glucuronide (EtG) and ethyl sulfate (EtS) positively detect and confirm patient alcohol use. Alcohol consumption by pain patients may present a real threat to their treatment, invoke physiological harm to the patient, and/or suggest to the physician that the patient possesses addiction tendencies. Physicians managing patients on central nervous system suppressants must monitor patient alcohol abuse due to the catastrophic and potentially fatal complications of mixing alcohol with these medications. Ethyl glucuronide has been identified as an important biomarker for alcohol ingestion primarily due to its extended detection window (up to 5 days after heavy ethanol consumption) and sensitivity to measurement by mass spectrometry(1). Alcohol can also modify the metabolic pathways for specific medications such as drug absorption and elimination, amplifying the need for absolute confirmation for patients taking pain medications.
Meperidine (Demerol®) is a narcotic analgesic prescribed for the relief of moderate to severe pain which is highly addictive when used long-term and can cause psychological and physical dependence. The abuse of meperidine poses a risk of overdose and death.
LC-MS/MS technology provides greater assay sensitivity and specificity so that in addition to identifying a patient’s prescribed pain medications, physicians can also help identify patients who may be diverting their medications; patients who may have obtained drugs from other sources; and patients who may be using alcohol or illegal drugs with their prescription medications.
James Slattery, CEO of Millennium Laboratories, said, "We are very proud of our laboratory team who quickly and reliably provide scientifically valid and legally defensible drug screening results for original drug compounds, drug metabolites or illicit substances. Our resources and research are geared toward providing our physician network with the most innovative technologies to help them deliver the best treatment and therapies to their patients."
About Millennium Laboratories
Founded in 2007 in America's biotech capital, San Diego, Millennium Laboratories is rapidly becoming the Urine Drug Testing (UDT) resource of choice for physicians and staff focused on the treatment of chronic pain. Millennium Laboratories provides the fastest turn-around time in the industry for drug test reporting and confirmation of results because the company is the only major Urine Testing Laboratory exclusively utilizing the latest cutting-edge technology Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC-MS/MS). The company is the only major Urine Drug Testing Laboratory licensed as a training facility for Toxicologist Scientists
Certified, state-of-the-art advanced training at Millennium’s 40,000 sq. ft. campus is an integral component of the University of California, San Diego’s (UCSD) doctoral program in Pharmacy. Led by Laboratory Director Amadeo Pesce, Ph.D., world-renowned Toxicologist and author, the Millennium Laboratories team are experts in mass spectrometry and high throughput chemistry. The company has developed proprietary methodologies that provide the fastest reliable urine drug testing (UDT) confirmations in the nation, usually within one business day. For more information, visit the Millennium Laboratories website, www.becausepainmatters.com
Reference:
1.Wurst FM, Skipper GE, Weinmann W. Ethyl Glucuronide -The Direct Ethanol Metabolite on the Threshold from Science to Routine Use. Addiction. 2003; 98 (suppl. 2): 51 – 61.
Nucynta™ is a registered trademark of Ortho-McNeil®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Oxycontin® is a registered trademark of Purdue Pharma, L.P.
Demerol® is a registered trademark of the Sanofi-Aventis Group.
Millennium Laboratories Contact:
Renee Bryan
Vice President of Marketing
Millennium Laboratories
877-451-3534
rbryan@becausepainmatters.com
Media Contact: Sandra G. Oak
Nsight Public Relations
321-591-1508
soak@nsightpr.com
Millennium Laboratories Urges Medicare to Save Reimbursement
For Point-of-Care Urine Drug Screen Devices
Controlled prescription drug diversion and abuse cost public and private
health insurers $72.5 billion per year, much of which is passed on
to consumers in higher insurance premiums.
Millennium Laboratories will petition Medicare on September 10 to retain reimbursement for point-of-care urine drug screening, a critical diagnostic tool and
societal defender against drug abuse.
San Diego, CA – September 8, 2009 – Millennium Laboratories, a leading provider of therapeutic drug monitoring and education to physicians and staff treating chronic pain patients, has announced the launch of an advocacy campaign to fight reimbursement cuts to point-of-care (POC) urine drug screen devices. Millennium will be presenting a solution to the Centers for Medicare and Medicaid Services (CMS) on September 10, 2009.
Millennium Laboratories’ proposed solution has three-fold benefits to Medicare, physicians, their pain patients, and to society. The solution will:
- Save Medicare dollars by moderating reimbursement rather than eliminating it.
- Retain POC urine drug screening as a critical diagnostic tool for physicians.
- Help protect patients and the public from the harmful consequences of prescription drug abuse.
Current Situation of Concern
Presently, a proposal is before CMS to drastically cut reimbursement for point-of-care test (POCT) devices used in urine drug screening. Outside interests are proposing these drastic cuts to CMS based on the premise that physicians should not bill CMS for multiple drug tests when doing in-office urine analysis. If only it were that simple.
Controlled prescription drug diversion and abuse cost public and private health insurers $72.5 billion per year, much of which is passed to consumers through higher health insurance premiums (2009 National Prescription Drug Threat Assessment – Drug Enforcement Agency). The White House Office of Management and Budget estimates that, including crime, loss of productivity and government anti-drug programs, the cost is $300 billion a year.
Physicians have few tools at their disposal for early detection of illicit drug use and drug diversion in patients. By limiting the physician’s reimbursement to conduct POCT to levels which are three to four times below their cost, the effect is disastrous. Millennium’s proposal is to moderate reimbursement rates to a level that allows physicians to retain the tool and properly cover their costs.
Early drug abuse intervention techniques reduce patient morbidity and mortality and decrease overall costs to society. POCTs also assist physicians who may under-prescribe legitimate medications for chronic pain patients because they fear the Drug Enforcement Agency’s (DEA) scrutiny and reprisal. POCTs are tools which achieve a balance between preventing drug abuse and diversion and maintaining proper levels of pain control for patients.
First Line of Defense against Drug Abuse: POCTs Save Lives
James Slattery, CEO of Millennium Laboratories, said, "As a former police officer I witnessed first hand the pain and destruction drug abuse has had on individuals, families, communities and our society. In 2007, I founded Millennium Laboratories to play a broader role in stemming the tide of prescription drug abuse, addiction and diversion."
Millennium Laboratories and coalition supporters maintain that POCTs are the first line of defense in identifying illicit and prescription drug abusers. If POCTs are not used by doctors who prescribe pain medications, many abusers, illicit drug users, and drug diverters will go undetected. This will cause an increase in deaths from prescription medications. In 2006 alone, 93% of unintentional overdose deaths involved non-medical use of prescription drugs (White House Office of Management and Budget). The discontinuation of judicious use of POCTs will also lower the standard of care for legitimate pain patients.
With the degree of drug morbidity and mortality that exists, Millennium contends it is unconscionable to adopt changes that will reduce surveillance when the welfare of society demands increased identification of undisclosed drugs.
Pain management expert Dr. Lora L. Brown, immediate Past President of the Florida Society of Interventional Pain Physicians and a pain physician with Coastal Pain Management and Rehabilitation, commented, "The POC test is so critical for objective, on-the-spot information for the pain specialist, that its removal would place countless patients and society in jeopardy. The utility of POC testing in the management of patients on controlled substances has never before been questioned. I firmly believe that developing a middle ground for cost containment will serve everyone's desires to protect our patients."
Solution that Addresses the Full Issues
Millennium Laboratories is presenting to the CMS an inclusive, medically ethical and financially sound solution that will reduce reimbursement for POCT devices to an amount that represents Medicare savings, and at the same time keeps the reimbursement at a level that makes it financially viable for physicians to use POCT devices.
Millennium Laboratories Research Study Reveals Lower Opiate Cutoff Levels Identify Higher Percentage of Patients Taking Illegal Drugs
Findings to be presented in poster session at the 2009 AACC Annual Meeting on July 23rd
San Diego, CA – July 22, 2009 – Millennium Laboratories, represented by its Laboratory Director, Amadeo J. Pesce, Ph.D., DABCC, will present a poster titled, “False Negative Immunoassay Screening Results in Pain Patients,” at the 2009 American Association for Clinical Chemistry (AACC) Annual Meeting, July 19 through July 23, at McCormick Place Convention Center in Chicago. The poster session will be presented on Thursday, July 23, 9:30 am – 12 noon.
A world renowned toxicologist, Dr. Pesce is the author of thirty-two textbooks and more than two hundred peer-reviewed articles, CDs and workbooks on chemistry, toxicology, and drug testing procedures. The “False Negative Immunoassay Screening Results in Pain Patients” poster presentation at this year’s AACC meeting concerns a research study conducted by Dr. Pesce and the Millennium scientific team of urine samples from 4,200 pain patients who were tested by immunoassay and LC-MS/MS for several drug classes, drugs, and metabolites. False negative results as determined by mass spectrometry were common. The greatest failures were for the benzodiazepine class (28%). Using a lower cutoff with LC-MS/MS the investigators observed double the number of cocaine-positive urines.
Dr. Pesce said, “The implications for clinical practice are that the national standards for cutoff levels need to be reexamined based on newer data available on drug abuse and lower cutoff levels. The quantitative drug analysis in pain patients is different from forensic drug testing because both positive and negative results have clinical interpretation as opposed to only positive results having significance. Negative results for patients on prescribed medication imply non-compliance or diversion. The usual practice for drug testing is to do an immunoassay screen followed by confirmation by mass spectrometry. Physicians are often unaware that common immunoassays do not detect many drugs of interest in pain management, which means negative results will be reported even though the patient is taking the drug.”
The Millennium Laboratories results support other documentation that in chronic pain patients false negative results are common when immunoassay screening methods are used and reiterate that the drug class descriptors used for many immunoassays are inaccurate. The research study found that 28% of immunoassay tests for benzodiazepines came up negative when the patient was found to be positive when tested by LC-MS/MS.
Another significant aspect of the Millennium Laboratories research is that it demonstrates with modern LC-MS/MS technology it is possible to lower the
cutoffs for detection and confirmation of illicit drugs such as cocaine. When the cutoffs for cocaine were lowered the number of illicit drug users doubled in the population of chronic pain sufferers tested.
Millennium Laboratories Research Study Reveals Lower Opiate Cutoff Levels Identify Higher Percentage of Patients Taking Illegal Drugs
Dr. Pesce explained, “Our lower levels of detection can identify a higher percentage of patients taking illicit drugs, possibly endangering a physician’s practice. Also, it prevents dismissing patients who may indeed be following their prescribed medication regimen.
About AACC
AACC (American Association for Clinical Chemistry) is an international scientific/medical society of clinical laboratory professionals, physicians, research scientists and other individuals involved with clinical chemistry and other clinical laboratory science-related disciplines. More information on AACC is available at www.aacc.org.
About Millennium Laboratories
Founded in 2007 in America's biotech capital, San Diego, Millennium Laboratories is rapidly becoming the Urine Drug Testing (UDT) resource of choice for physicians and staff focused on the treatment of chronic pain. Millennium Laboratories provides the fastest turn-around time in the industry for drug test reporting and confirmation of results because the company is the only major Urine Testing Laboratory exclusively utilizing the latest cutting-edge technology Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC-MS/MS). The company is the only major Urine Drug Testing Laboratory licensed as a training facility for Toxicologist Scientists. Millennium Laboratories is in a dynamic growth mode, continuing to post double-digit growth quarter over quarter.
Certified, state-of-the-art advanced training at Millennium’s 40,000 sq/ft. campus is an integral component of the University of California, San Diego’s (UCSD) doctoral program in Pharmacy. Led by Laboratory Director Amadeo Pesce, Ph.D., world-renowned Toxicologist and author, the Millennium Laboratories team are experts in mass spectrometry and high throughput chemistry. The company has developed proprietary methodologies that provide the fastest reliable urine drug testing (UDT) confirmations in the nation, usually within one business day. For more information, visit the Millennium Laboratories website, www.becausepainmatters.com