Opiates Agreements and Drug testing in Pain Management

Opiates Agreements and Drug testing in Pain Management Lokesh Ningegowda, MD Department of Pain Management Anesthesiology Institute, Cleveland Clinic Director Department of Pain Management at Twinsburg Family Health and Surgery center OBJECTIVES Define : Tolerance, dependence, addiction and abuse/ misuse Identify low, medium and high risk patients Need for opioid agreement and urine drug screening Constituents of opioid agreement Types of urine drug screening techniques available Interpreting the result of urine drug testing Types of opioids and their metabolites Limitations of Urine drug testing (false positive and False negative results) Scenario 1 55 yrs F with h/o diffuse pain head to toe for years (>10yrs) Had multiple interventional procedures with no relief. Gradual escalation of opioids and currently on 200 mcg of Fentanyl patch and 10 mg oxycodone Q 4 hrs for BTP. Her pain physician lost license and she presented to establish care. Exam-no neurologic deficits. Diffuse tenderness. She has long nails (>5 inch) both hands- she wants to create Guinness record for longest nail On disability. Imaging spine- mild to moderate artritic changes. No significant neuroforaminal compromise

Scenario 1 contd Reviewed records extensively from the prior provider. Pain always 9/10 on all visits. Multiple lumbar spine/ cervical spine procedures- with no documented benefit. Patient nonfunctional (She has an aid to help her ADL s-? Due to nail!!!!) Recommended evaluation and management by chronic pain rehabilitation program for multidisciplinary approach including but not limited to detox, functional restoration, mood improvement Patient got upset and angry I have been getting these meds for years and you can t change that. Give me my meds Did not want to go through the program. Offered weaning gradually Initially agreed. But after few follow up visits, established care with another provider!!! Scenario 2 72 yrs F with h/o prior back surgery 8 yrs ago. Continues to have low back pain. Not a surgical candidate. Lives by herself and does her daily chores. States that of late it has been difficult to do her daily activity due to significant pain. Failed NSAID s, adjutants (had SE s), interventions. Asks her physician can she get something else for pain so she can do her daily activity (says that one of her friends takes vicodin twice a day and it helps her friend!!!) Physician says that narcotics are bad and he does not believe in narcotics for chronic pain. He states that she can get addicted to vicodin. Physician recommends that the patient has to realize that there is no treatment for her problem and advises the patient to learn coping skills. INTRODUCTION Opioids are extensively used in treating chronic pain despite limited evidence of its effectiveness in CNMP. Chronic opioid use is controversial for managing chronic Nonmalignant pain (CNMP) Limited or Lack of proven evidence on efficacy and improvement in functional outcome. Tolerance, Dependence, Hyperalgesia Abuse potential (addiction and diversion) As clinician our responsibility is to treat patients with chronic pain and prevent abuse or overuse of opioid medications.

What is the controversy? Under treatment of pain vs Drug abuse and addiction Limited tools for treating pain vs Lack of objective data on efficacy of long-term therapy Physicians as caregivers vs Law enforcement agents Medical malpractice vs Criminal activity The problem Opioid abuse in patients with chronic pain 18-41% Illicit Drug use in patients in chronic pain management setting is 14-16 % Prescription drug diversion is an increasing problem. There has been increase in health care costs in patients with non-adherence to opioiod therapy. The Problem Opioid use (mg per person treated) has increased by 402% from 1997-2007 Use of oxycodne increased by ~ 900%. Evidence is limited in proving effectiveness of chronic opioids in improving pain relief, functional status and QOL indicators. In one study the results showed worse pain, higher health care cost and utilization, lower activity levels in chronic opioid treated patients compared to patients not using opioids.

Prescription Abuse Illict Drug use Misuse or abuse of medications

ADDICTION TOLERANCE DEPENDENCE Addiction Tolerance Dependence Abuse ADDICTION Compulsive use of a medication despite dysfunction and harm It is characterized by behaviors that include one or more of the following: Loss of control over drug use Compulsive use Continued use despite harm Craving or preoccupation with obtaining opioids Differentiate between addiction and pseudo-addiction Pseudo-addiction patient Will stop dose escalation or reduce dose once pain is controlled Will not try to achieve euphoric effects. No signs of intoxication (Sedation, confusion) Focus on side effects and consequences of side effects Follows recommendations for other forms of treatments.

DEPENDENCE Physical dependence is a state of adaptation that is manifested by a drug class specific withdrawal syndrome that can be produced by: abrupt cessation rapid dose reduction administration of an antagonist. TOLERANCE Need for increased dosage of a drug to produce the same level of analgesia that previously existed. It is a state of adaptation in which exposure to a drug results in a diminution of one of more of the drug s effects over time. Abuse Willful misuse of opioids or other drugs which may include drug diversion This is a maladaptive pattern of substance use leading to: Significant impairment Using inappropriate substances Involved in recurrent substance related legal problems Continuing use in the face of adverse consequences

ADDICTION TOLERANCE DEPENDENCE Prevention of opioid abuse Treatment Plan and expectations Discuss Treatment Plan, goals and expectations (pain reduction Vs Pain free status) Discuss Opioid side effects and risks Informed consent and opioid agreement Discuss about periodic UDT, OARS, pill count etc. Define exit strategy in case of abbrent drug behaviour Consequences of non compliance Opioid risk assessment Identify patients risk profile LOW risk: Chronic non cancer pain No hx of substance abuse No major psycho/ social issues. MEDIUM risk Prior hx of substance abuse or dependence Family hx of substance abuse Significant psychiatric issue (depression, bipolar) HIGH risk Active addictive disorder (determined by hx or UDS) Major psycho social issues Should be managed in a multidisciplinary approach including pain specialist, addiction medicine expert and psychiatrist.

Use screening tools to monitor opioid adherence Identify patients needing chronic opioid therapy Establish realistic expectations and guidelines CAGE and CAGE- AID Opioid risk tools (ORT) The Screener and Opioid Assessment for Patients with Pain (SOAPP/ SOAPP-R ) Drug abuse screening test (DAST) Pain Medication questionnaire (PMQ) Screening tools for addiction risk (STAR) Etc, No single tool can be uniformly accepted and broadly applied. Opioid risk assessment tool Red flags for abuse Lost/stolen prescriptions Repeated request for early refills Calling unfamiliar physicians Demands end-of-office-hour appointments or arrives just after close Refuses physical examination or tests ( I am here for my oxys and percs!!) Prohibits release of medical records Cannot or will not provide past providers Uses excuses of visiting from out of town and lost or stolen prescriptions No medical basis for allergies to nonopioids Unusual knowledge of controlled substances History of previous substance abuse by the patient and/or family are strong indicators of the likelihood of continued abuse.

Prescription drug abuse scams I was robbed (Full bottle of medication!!!) I am allergic to My house burned down The only thing that has worked for me You are the first doctor I can trust and understands You are the most handsome/ beautiful doctor I have ever met The dog ate (medications/ prescription).. ADDICTION TOLERANCE DEPENDENCE Opioid Informed Consent and Agreement Opioid Informed Consent and Agreement Opioid informed consent: Discuss Risk, benefits, alternatives of chronic opioid therapy and sign the consent. Discuss in detail about the side effects. Opioid agreement Should include but not limited to: One prescribing physician One designated pharmacy Not to sell or share medications Not to abuse illicit drugs like cocaine Urine/ serum drug screening when requested No early refills or early medication call in. Lost or stolen medications would generally not replaced and may need to be reported to the police before giving additional prescription. Reasons for which opioid therapy may be discontinued eg: violation of agreement, uunauthorised dose escalation, etc.

Pain Management Department OPIOID MAINTENANCE AGREEMENT The long-term use of Opioid medications (narcotic analgesics) is somewhat controversial because of the uncertainty regarding the extent to which this treatment actually improves the patient s quality of life. There is the potential risk for addiction. The extent of this risk is not certain. Because these drugs all have potential for abuse or diversion, rather strict accountability is necessary when these medications are prescribed. The goal of treatment is to reduce pain to a tolerable level that allows increased function. Daily use of narcotics is associated with certain risks; the risks include but are not limited to: Addiction. Withdrawal symptoms. Allergic reactions, overdose and/or fatal complications. Breathing problems. Drowsiness, dizziness and/or confusion. Impaired judgment and inability to operate machines or drive motor vehicles. Nausea, vomiting and /or constipation. Development of tolerance. Pain Management Department OPIOID MAINTENANCE AGREEMENT I agree to the following guidelines: I will take this medication only as prescribed and I will not change the amount or dosing frequency without authorization from my physician. Unauthorized changes may result in my running out of medications early, and early refills will not be allowed. I will obtain all narcotics from one physician or, during his or her absence, by the covering physician. Requests for pain medications from the on-call physician (nights and weekends) will not be honored. I will obtain all narcotics from one pharmacy. I must notify the Pain Management Department if I change pharmacies. The pharmacy that I have selected is: ; phone number is:. The prescribing physician has complete liberty to discuss fully all diagnostic and treatment details with the pharmacists at the dispensing pharmacy for purposes of maintaining accountability. I will submit to random pill counts, urine and/or serum toxicology screens as requested to monitor my compliance. Presence of unauthorized substances may prompt referral for assessment of addiction and discontinuation of further Opioid prescriptions. I will not share, sell or otherwise permit others to have access to these medications. Medications will not be replaced if they are lost or stolen. It is expected that I will obtain a safe for my medications and guard against theft. I understand that prescriptions may be issued early, for example, if the treating physician is going to be out of town, or if I am going to be out of town when a refill is due. However, I also understand and accept that these prescriptions will contain instructions to the pharmacist that they not be filled prior to the appropriate date. If legal authorities have questions concerning my treatment (as might occur, for example, if there was a concern that I was obtaining medications at several pharmacies), I hereby waive all confidentiality, including my patient-physician privilege and I consent to giving the authorities full access to my Records of narcotic administration. I UNDERSTAND AND AGREE THAT FAILURE TO ADHERE TO THESE POLICIES WILL RESULT IN PERMANENT CESSATION OF NARCOTIC PRESCRIBING BY THIS PHYSICIAN AND MAY RESULT IN MY DISMISSAL FROM THE PAIN MANAGEMENT DEPARTMENT,. Patient Signature*** Date Physician Signature Date ***Patients receiving methadone for pain management additionally agree to not consume alcohol and further agree to not add or discontinue ANY medications, including over the counter drugs without contacting the pain center. / / (patient initials and date) Document Four A s on every visit Analgesia Adverse events ADL s Aberrant drug related behaviors and Physical examination Mr. XXX is on MS contin for his chronic low back pain. He states that his pain and activity is improved by medications and denies any side effects from the medications. There are no signs of misuse, abuse or diversion and patient is compliant with the recommendations and treatment plan

Termination of Opioid Agreement Unauthorized dose escalation repeatedly Doctor shopping (getting additional scripts from different physicians) Use of recreational / illicit drugs UDT negative for prescribed drugs (after confirmation tests) UDT positive for non prescribed drugs (after confirmation tests) If patient has breached opioid agreement Detox consult / substance abuse therapy Chronic pain rehabilitation program No further opioid or schedule 2 drugs and wean off narcotics but you cannot abandon patient If you feel patient has agenda of misleading you and patient does not indicate by actions and words that he will follow a plan then consider a discharge letter with a list of other providers in the area. If patient was negative for prescribed drug he will not need to be tapered off his medications ADDICTION TOLERANCE DEPENDENCE Urine Drug Screening

UDT UDT is a part of Prescription Monitoring in patient on chronic opioids for CNMP. Some states it is mandatory. If physicians are ordering UDT, it is critical to be proficient in interpreting the results. Other methods include: Patient self report Behavioral monitoring OARS Pill count Drug testing ( urine, blood, saliva, hair, sweat) UDT is regarded as Gold standard compared to other tests. Why do we need to do Urine Drug Testing?? To detect presence or absence of prescribed opioid (Effectively monitor patient compliance of therapy) Detect presence of non prescribed drugs and presence of illicit drugs ( To rule out abuse) UDT provides Objective evidence regarding compliance of medication management UDT screening This should not be confrontational The patient has to understand that this is like any other laboratory test. Thus a physician would respond to adherence monitoring or screening for opioid abuse similar to how one would respond to an abnormal liver function test or anemia!!!!

Advantages of urine testing over other specimens Best biologic specimen for detecting presence or absence of certain drugs with good specificity and sensitivity. Ease of administration. Cost effective Metabolites excreted for longer period allowing longer detection time. Limitations of UDT (Screening methods) Cutoff threshold- may give rise to false negative results if below threshold level Cross reactivity can give rise to false positive results Pharmacokinetics, pharmacodynamics and pharmacogenetics - variation. Lab technology may not be available in some practice area. Chance of adulteration Practitioners need to be familiar with applications and implications else may lead to inappropriate patient discharges and possible legal consequences. Who should be tested? Careful Patient selection in high risk patients Vs Universal precaution approach Evidence is limited UDT should be considered standard practice for all patients treated with chronic opioids This will reduce the risk of substance abuse Protect physicians from accusations of discrimination Prevent monitored patients from feeling stigmatized as having exceptional risk profile

Collecting urine specimen Obtain history- including last dose taken, any additional medications or supplements taken recently. Ensure samples are free of contaminants and carefully labeled Minimize the likelihood of fraudulent sample Federally mandated testing (DOT) requires water shutoff, colored toilet water, chain of custody, split sample, secure storage of non- negative samples Detecting adulterated urine (Specimen Validity test) Inspection: color, foaming characteristic (normally yellow color with foam and urine of same color) Temperature within 4 mins of collection ( 90-100 deg F). Many collection cups contain temp strip. Urine ph ( 4.5 to 8) Creatinine level (Normal >20mg/dl) Tests to detect various adulterants If urine does not meet these parameters retest Witnessed collection specimen If urine sample continues to be outside of norm repeatedly, consider as refusal to test Adulteration or subversion of urine drug testing Use of diuretics Substitution of specimen Urinator - freeze dried clean urine. Quick reconstitution and warmed to body temperature. Available on internet. Urine luck Urinaid - contains gulteraldehyde which interferes with IA. Niacin- prevents detection of THC Others: lemon juice, liquid soap, vinegar, visine eye drops etc,.

Available online Internet based products Drug-Testing-Solutions.net will not sell products to people under the age of 18. Rescue Cleanse - 16oz Detox Drink, by Clear Choice Unit price: $40,00 each or get 4 for the price of 3 : One Shot Concentrate Drug Detox Drink - 0.7 oz. Concentrate, by Clear Choice Unit price: $45,00 each or get 4 for the price of 3 : Hair Follicle Shampoo & Hair Purifier Drug Removal Treatment Pack - 1 Kit, by Clear Choice Unit price: $75,00 each or get 4 for the price of 3 : Herbal Pre-Cleanse Drug Trace Elimination Formula - 60 Tabs, by Health TechUnit price: $25,00 each or get 4 for the price of 3: Urinalysis Panel Instant Home Drug Test Kit, Urine Drug Testing for Marijuana ( THC ) - 1 testing kit, by Health Tech Unit price: $15,00 each or get 4 for the price of 3 : Instant Clean Urine Drug Test Additive, 8ml micro-vial, by Clear Choice Unit price: $75,00 each or get 4 for the price of 3: SPIKE Urine Drug Test Additive, by Clear Choice Unit price: $125,00 each or get 4 for the price of 3: Oral Clear Saliva Testing Solution Unit price: $90,00, each or get 4 for the price of 3: Rescue Cleanse - 32oz Extra Strength Detox Drink, by Clear Choice Unit price: $50,00 each or get 4 for the price of 3: UDT Methods Screening test (Lab based or Point of care testing in the clinic) Immunoassay technique Relies on antibodies to detect presence of a particular substance Color change indicates presence of the drug or metabolite Confirmation test (Lab based) GC/MS( Gas chromatography/ MS) LC/MS/MS (Liquid chromatography tandem mass spectrometry) HPLC (High performance liquid chromatography) Confirmation test is done if false positive or false negative test is suspected

Screening test Screening test can be: Class assay for specific class of drugs like opioids, benzo etc,. or Analyte specific assay for specific drugs like oxycodone, cocaine, fentanyl etc,. Screening test Advantages: Rapid testing Can be tested as POC in the clinic Minimal training is required for staff to do this Inexpensive Can handle high volume Disadvantages: Qualitative (Non quantitative)- need to be above cut off threshold values to detect Less sensitive to semi-synthetic / synthetic opioids (oxycodone)- false negative Class assay cannot differentiate different drugs of same class (Oxycodone, methadone, fentanyl) Subject to cross reactivity with other substances (Quinolone antibiotics)- false positive Cannot determine exposure time, dose, frequency of use Confirmatory test- Laboratory test Advantages: Quantitative Highly specific and sensitive More accurate than POC testing Will detect very low levels Disadvantages: Relatively expensive Need laboratory services Takes longer time to get results

Which POC testing should be sent to the lab? Why don t we just do confirmation lab tests for everyone? Confirmation should be done for: o All samples testing negative for prescribed opioids o Samples positive for non prescribed opioids o Sample positive for illicit drugs Cost between immunoassay (20$) to GC/ MS/ LC ( 200-1000$) is high Routine excessive UDT - confirmation can result in annual charges of > 10,000 $. (Eg: If all the patients on chronic opioids gets monthly refills and when they come for refills, UDT with confirmation is mandatory!!!!!- is it cost effective????) Appropriate use of screening test (immunoassay) with confirmation of abnormal result will be cost effective with provision of appropriate care. UDT screening in office - Legal issues Practitioners using POC testing need to be aware of whether the system used is compliant with methods and assurances established by the Clinical Laboratory Improvement Advisory Committee (CLIAC). A Clinical Laboratory Improvement Amendments (CLIA) waiver is required to perform certain tests including urine immunoassay. Only immunoassay tests for certain drugs are CLIA waived, and these may be Performed in the office. UDT legal issues contd Abuse of UDT screening by physicians and wrong coding and billing - (CMS) have changed codes for UDT- screening tests to code G0434 effective January 10, 2010. Private insurance companies code 80104. Can bill only once even though multiple drugs are tested on one strip - Earlier codes were misused and Tox screens were billed by some practices for multiples of number of drugs tested in the screen. ( $ 20 Vs $ 250-500 for TOX screening in office)!!!!!!! - Confirmation codes: G0431 (CMS) and 80101 (Private insurance). (Physician needs to be aware of the amount the drug testing companies are billing the insurances!)

UDT Drugs tested Opioids including oxycodone and methadone Benzodiazepines Barbiturates Marijuana Cocaine Amphetamines This depends on the type of kit being used. Some kits may not be testing for specific opioids and may by generic for opiates in which case there is a chance for high incidence of false negative for synthetic and semi synthetic opioids. Types of opioids Natural: Morphine, Codeine Semi synthetic: Heroin, hydromorphone (dilaudid), hydrocodone (vicodin), oxycodone (percocet), oxymorphone (opana), buprenorphine (suboxone) Synthetic: Fentanyl, meperidine, tramadol, methadone, dextropropoxyphene, Tapentadol Metabolites of Opioids identical to pharmaceutical opioids Morphine Hydromorphone (minor) Hydromorphone Dihydromorphine Oxycodone Oxymorphone Codeine Morphine, Hydrocodone (minor) Hydrocodone Hydromorphone, Dihydrocodine Heroin Morphine, 6 monoacetyl morphine (6 MAM) Oxymorphone None Fentanyl None Tramadol None Methadone None Buprenorphine None

Differentiating which opioid was taken Presence of synthetic/ semi synthetic opioids like oxycodone, fentanyl, tramadol, methadone and buprenorphine if not prescribed means that they were ingested and indicates abuse. (Because no other opioid produces these as metabolites) Presence of morphine, oxymorphone, hydrocodone, hydromorphone can be due to metabolites of other opioids. Presence of these metabolites even though not prescribed may not indicate abuse if the prescribed opioid is known to produce one of them as metabolites. Drug Detection time in urine Morphine, Codeine or Heroin Codeine: metabolized to Morphine and Hydrocodone (minor) (Small amount of Hydromorphone) Heroin: metabolized to Morphine and 6-MAM (Monoacetyl morphine) If patient is prescribed codeine and UDT is positive for Morphine and codeine, quantitative test (GC/ MS) is done to know the level of morphine. If morphine level is higher then codeine, it may indicate patient may be taking morphine or heroin separately

Oxycodone and Oxymorphone Oxycodone is metabolized to noroxycodone and oxymorphone If UDT of patient prescribed oxycodone is positive for oxymorphone, quantitative analysis needs to be done to confirm that relative quantity of oxycodone is > oxymorphone If patient is prescribed oxymorphone, it is easy to interpret the UDT of that patient since it does not produce any metabolites which can be mistaken for prescribed opioids. Hydrocodone Most commonly prescribed opioid analgesic Metabolised to dihydrocodeine and hydromorphone. Codeine may produce hydrocodone as a minor metabolite Synthetic/ Semi synthetic opioids Presence of the following in UDT indicates that they were taken since these are not produced as metabolites of other opioids. Oxycodone Fentanyl Methadone Tramadol Buprenorphine Propoxyphene If a patient is tested positive for one of the above and it is not being prescribed it indicates abuse

Non opioid drugs of abuse Benzodiazepines: False positive POC (IA) NSAID s fenoprofen, flubiprofen, indomethacin, tolmetin, zoloft (Confirmation by GC/ MS) Cocaine: POC (IA) is sensitive for cocaine and its metabolites benzoylcgonine and ecgonine methylester. Little cross reactivity. Amphetamine / Methamphetamine: Cross reactivity to OTC meds like ephedrine/pseudoephedrine, trazodone, selegeline, bupropion. Confirmation by GC/MS. Marijuana: -THC. Passive exposure to marijuana does not produce positive urine test. False positive with antiviral efavirenz (antiretroviral) or PPI pantaprazole. Presence needs confirmatory test by GC/MS. Drug Cross Reactants (false Positive) DRUG Cannabinoids: Cross reactant (false+) NSAIDS, PPI- Protonix, Efavirenz/ Sustiva, rifampin Opioids: Poppy seeds, rifampin, ciprofloxacin, dextromethorphan, quinine, Quinolones Amphetamines: ephedrine, pseudoephedrine, trazodone, bupropion, desipramine,amantadine, ranitidine, vicks vapor spray, methylphenidate PCP: Chlorpromazine, thioridazine, meperidine, dextromethorphan, diphenhydramine, doxylamine Benzodiazepines: Oxaprozyn (Daypro), Zoloft, some herbal agents ETOH: asthma inhalers (sometimes) Methadone: Benadryl, chlorpromazine, seroquel Too many to remember??? No need to remember all Just remember that there is chance of cross reactivity and any false positive or false negative screening test need to get confirmatory test

Algorithm for urine drug testing Baseline UDT: helps in establishing the reliability of patients reported substance abuse. Universal approach- all patients are treated in similar fashion Monitoring for compliance: Baseline monitoring Compliance monitoring within 1-3 months routine random monitoring every 6-12 months Patients with abnormal results or high risk patients may need more frequent monitoring No evidence to suggest who should have UDT and how often UDT needs to be done UDT results 5 scenarios 1. Positive for prescribed drug and negative for other drug or illicit drug 2. Negative for prescribed drug: Possible noncompliance, diversion, false negative results. Needs confirmatory test with GC/ MS. Test may be repeated. 3. Urine drug positive for nonprescribed opioid or benzodiazepine: False positive, metabolites of other prescribed opioid, multisourcing. Confirmation by GC/ MS, get OARS report (prescription drug record) 4. UDT positive for illicit drug:? Cross reactivity to other drugs or abuse. Confirmation and appropriate action 5. Sample tampering: Repeat UDT supervised/ witnessed collection Interpretation of results UDT should not be considered as definitive and decision should not be based on UDT alone. UDT should be considered in tandem with other forms of patient monitoring such as regular follow up, behavioral observation, risk assessment, reviewing prior history of drug abuse or substance abuse.

10 steps of Universal Precautions in Pain Medicine 1) Make a diagnosis with appropriate differential 2) Risk assessment including addictive disorders 3) Informed consent 4) Treatment / opioid agreement 5) Pre and post intervention assessment of pain level and function 6) Appropriate trial of opioid therapy with or without adjunctive medication 7) Reassessment of pain score and level of function 8) Regularly assess the 4 A s of pain medicine 9) Periodically review pain diagnosis and co morbid conditions including addictive disorders 10) Documentation ADDICTION TOLERANCE DEPENDENCE Case studies Case #1 36 yrs M Past h/o TAA dissection with emergent repair Post op brachial plexus injury noted. Eventually developed B/L UE weakness and neuropathic pain Is on anticoagulation (Coumadin 20 mg/ day) with regular INR monitoring Has tried multiple modalities of treatments- adjuvant, membrane stabilizers, no significant improvement Started on oxycodone ER titrated upto 60 mg. Stable for 1 yr and hence decided to reduce the dose and observe. 30 mg bid of oxycontin gave him adequate pain relief. He continued to work at subway as a manager. Urine tox screening in office negative for opiate / other illicit drugs.

Case #1 contd Patient on high dose of coumadin - rapid metabolizer Patient had willfully reduced the dose UDT confirmation test done. Showed presence of oxycodone. Continued the medication regime Case # 2 46 yrs M truck driver H/o injury to the left leg following MVA- had reconstructive surgery. Needs repeat surgery in one year. Is on Percocet 10/325 tid and protonix for GERD. Continued to work UDT on follow up shows: Positive oxycodone, Positive THC Discussed the results with the patient - patient states that he was in a party yesterday and some his friends were doing some pot probably it is from that smoke. Case #2 contd Passive smoking of marijuana does not produce + THC on UDT But Protonix (Pantaprazole ) can cause false positive THC on UDT. Confirmatory test (GC/ MS)- Negative for THC. FOLLOW UP: Discussed the findings with the patient. Reviewed the opioid agreement. Consider Change percocet to longer acting formulation. Reestablish the guidelines of treatment

Case # 3 68 y F with h/o chronic low back pain. She had two lumbar spine surgeries. Had few interventional pain procedures with short term pain relief. Did not want to proceed with advanced interventional techniques. Adjutants gave moderate relief. Currently stable on oxycontoin 10 mg bid. Comes for regular office visit and med refill. Last urine screen done 1 year ago. She has been taking some Robitussin DAC (Codeine, guaifenesin, pseudoephedrine) for cough and respiratory symptoms. Urine Tox screen (UDT): positive for opioid, negative for oxycodone and positive for amphetamines. What do we do? Case # 3 contd Oxycodone- semisynthetic opioid. High false negative in screening test. Codeine: Metabolizes to morphine and hydrocodone Pseudoephedrine: cross reactivity with amphetamines (False positive) Called PCP office to make sure Robitussin DAC was prescribed Confirmation test sent to lab for GC/ MS: Positive for oxycodone, oxymorphone, codeine (As expected) Positive for morphine- but levels low (As expected) Negative for amphetamine (cross reactivity from pesudoephedrine) Patient informed about the test and medication continued. Case #4 36 yrs M with h/o AIDS on treatment with retrovirals (Efavirenz). h/o THC abuse in the past. Claims to be off THC for > 3 yrs. Has severe peripheral neuropathy. Medication management by MS contin 15 mg bid. Urine tox screen: positive for opioids, and THC

Case # 4 Urine confirmation test: Positive for morphine. Negative for THC Efavirenz- cross reactive to THC and had caused false positive tox screen result. Continue medication management with UDT on a regular basis. Case # 5 35 Yrs M with h/o chronic low back pain. Was recently discharged by a pain practice for medication non compliance. On first visit, after H & P, baseline Urine Tox screen was done. Positive for cocaine. Patient admits to use of cocaine. Do we need a confirmatory test?? Case # 5 contd Urine screen postive for cocaine and patient agrees to use cocane. There is not much cross reactivity to cocaine There is no need for Confirmation test ( Can save some $$$) Patient referred to addiction medicine and Multidisciplinary chronic pain rehab program.

ADDICTION TOLERANCE DEPENDENCE Oral fluid drug testing Company claimed benefits Administered anywhere in 2-5 mins Accuracy of blood No adulteration or excuses Always observed / witnessed collection Detects drugs and metabolites Detects recent usage and trace quantities. Low cut off levels Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics - FDA What does the ER/LA opioid analgesics Risk Evaluation and Mitigation Strategy (REMS) include? A. The central component of the ER/LA opioid analgesics REMS is an education program for prescribers (e.g., physicians, nurse practitioners, physician assistants). Under the REMS, sponsors of ER/LA opioid analgesics will make available education programs to all DEA registered prescribers, including prescribers of ER/LA opioid analgesics. FDA expects that sponsors will meet this obligation by providing educational grants to accredited CE providers to offer training to prescribers at no or nominal cost. These CE activities must cover the content and messages of a blueprint developed by FDA for this purpose (see: FDA Blueprint for Prescriber Education (PDF - 104KB) 3 ). Prescriber education will include drug information on ER/LA opioid analgesics; information on assessing patients for treatment with these drugs; initiating therapy, modifying dosing, and discontinuing use of ER/LA opioid analgesics; managing therapy and monitoring patients; and counseling patients and caregivers about the safe use of these drugs. Additionally, prescribers will learn how to recognize evidence of and potential for opioid misuse, abuse, and addiction. The ER/LA opioid analgesics REMS will also include a patient counseling document for prescribers to give to patients, helping prescribers to properly counsel patients on their responsibilities for using these medicines safely. Patients will receive from their pharmacist an updated one-page Medication Guide along with their prescription that contains consumer-friendly information on the safe use and disposal of ER/LA opioid analgesics. Included in the guide are instructions for patients to consult their health care professional before changing doses, signs of potential overdose and emergency contact instructions, and advice on safe storage to prevent accidental exposure to family members.

Suggested readings: 1) Urine drug testing in chronic pain Pain physician 2011;14:123-143- Review 2) Urine toxicology testing in chronic pain management Postgrad Med. 2009 Jul;121(4):91-102. Review. 3) Role of urine drug testing for patients on opioid therapy Pain Pract. 2010 Nov-Dec;10(6):497-50 4) Monitoring opioid adherence in chronic pain patients: Assessment of risk of substance misuse Pain Physician 2011; 14:E119-E131 PILLS KILL - PAIN DOES NOT Thank you ningegl@ccf.org