Udt pdmp cme 2015
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This document provides information on best practices for prescribing opioid therapy and managing pain patients, including key facts on the pain management epidemic. It discusses definitions of chronic pain and addiction. Guidelines are provided on initial patient assessment, implementing opioid therapy if appropriate, identifying addiction risks, prescribing protocols, urine drug testing protocols, and legislation related to prescription drug monitoring programs. The goal is to provide physicians with tools and guidelines for safely and effectively managing patients with chronic pain.
Udt pdmp cme 2015
- 1. Administration, Management and Control for Pain Management Drugs and Therapy Alberto Rivera Sanchez, MD FAAPMR, DABPM Pain Management Subspecialist Diplomate of the American Board of Pain Medicine February 22, 2015
- 2. “Physicians prescribe drug of which they know little for diseases they know even less, to people of which they know nothing…” Voltaire, 16th century
- 3. Learning Objectives Key facts and statistics on the pain management epidemic – illicit drugs, prescription drugs and drug abuse Better understanding of chronic pain and the impact on the patient and your practice Best practices for prescribing opioid therapy
- 4. Facts & Stats on the Pain Management Epidemic Many physicians do not understand the risks and management of addictive disease. Physicians traditionally receive little or no education about pain management or the treatment of addiction. OxyContin, methadone and Percocet availability have increased dramatically in recent years because of over-prescribing practices by physicians and the internet. Puerto Rico Health and Anti-Addiction Services Administration 4 million Americans used a prescription drug last year for non-medicinal purposes
- 5. Facts & Stats on the Pain Management Epidemic Overall, health-care providers wrote 259M prescriptions for painkillers in 2012, based on prescription data gathered from retail pharmacies by a commercial vendor Centers for Disease Control New federal data show the rate of deaths involving prescription painkillers have like Oxycontin and Vicodin more than tripled between 1999 and 2012. Centers for Disease Control Report, December 2014 Heroin and pharmaceutical drugs are among the most abused substances in Puerto Rico The National Drug Intelligence Center
- 6. Facts & Stats on the Pain Management Epidemic 8% of the national population receive chronic opioid therapy U.S. Department of Veterans Affairs, Monday, November 17, 2014 Americans constitute less than 5% of the world population, but consume 80% of the opiates Substance abuse is one of Puerto Rico’s most compelling socio-medical problems Mental Health and Anti-Addiction Services Administration DEA Diversion Drug Trend Report identifies hydrocodone as the most commonly diverted and abused controlled pharmaceutical in the U.S. Every day 46 people die from an overdose of prescription painkillers HealthDay News, Wednesday, July 2, 2014, Dr. Tom Frieden, Director of CDC
- 7. Trend in Prescription Drug Abuse 52 Million people in the U.S. over the age of 12 have used prescription non- medically in their lifetime 6.1 Million have used them non-medically in the past month 25% of the U.S. consumes 75% of the world’s prescription drugs In 2010, enough prescription painkillers were prescribed to medicate every American adult every 4 hours for 1 month National Institute on Drug Abuse The U.S. spends $200 Billion each year on medical care stemming from improper or unnecessary use of prescription drugs Medscape, 2014
- 8. The Pain Dilemma Chronic Pain Opioid Abuse
- 9. The Scales of Opioid Therapy Have Tipped Liberal use of opioids for chronic non- malignant pain Restricted use of opioids for chronic non-malignant pain. Use for cancer pain.
- 10. Pain epidemiology Pain is undertreated Fear of patient harm Fear of regulatory, legal or licensing penalties Addictive disorder or risk for addiction Divert or misuse of medications
- 11. Definitions Chronic nonmalignant pain Unrelated to cancer Pain greater than 90 days after surgery. Pain that persists beyond the usual course of the disease and beyond the expected time for healing from injury or trauma. Pain which is associated with long term incurable or intractable medical illness or disease. i.e. Chronic pain from abdominal adhesions post-operative.
- 12. Initial Patient Assessment Trial of Opioid Therapy Alternatives to Opioid Therapy Patient Reassessment Implement Exit Strategy Comprehensive Pain Management Plan Continue Opioid Therapy Patient Selection Prescribing Opioid Therapy
- 13. Prescribing Opioid Therapy Informed Consent Pain Contract Risks of the Opioid Therapy Addiction, Abuse Cognitive Changes Hormonal Changes Withdrawal State Short-Term Use (6 months) Prescription Monitoring Program Addiction Screening Assessment Urine Toxicology Pain medication is a PRIVILEGE not a RIGHT!
- 14. Prescribing Opioid Therapy ABCDPQRS for Opioid Risk Assessment (ICSI 2014) Alcohol Use BDZ Clearance and Metabolism (GFR <60 Morphine & Meperidine are toxic, GFR <30 cause delay elimination of oxycodone and hydrocodone) (Hepatic impairment use low dose or no APAP opioid combinations) Delirium, Dementia and Falls Risk Psychiatric Comorbidities Opioids are powerful anxiolytics Depression and Anxiety Dz Chilhood Sex trauma and/or ADHD history OCD, PTSD
- 15. Prescribing Opioid Therapy Query the Prescription Drug Monitoring Program Respiratory Insufficiency and Sleep Apnea Safety Safe driving Safe work Safe storage Safe disposal
- 16. Prescribing Opioid Therapy & Challenges Associated with Opioids High dose pain medication almost never improves function Opioid Induced Hyperalgesia is a real and common consequence of chronic opioid therapy Prescription opioid pain medications such as OxyContin and Vicodin can have effects similar to heroin when taken in doses or in ways other than prescribed. Research now suggests that abuse of these drugs may actually open the door to heroin abuse www.drugabuse.gov/publicaitions/drugfacts
- 17. Addiction Using a drug in a compulsive fashion not for its intended medical effects but for its pleasant, psychic effects. World Health Organization The abuse results in physical, psychological or social harm to the abuser who continues the use despite the harm.
- 18. Addiction and Abuse Behaviors Drug hoarding during periods of reduced symptoms Requesting specific drugs Acquisition of similar drugs from other sources Multiple unsanctioned “self” dose escalations Unapproved use of the drug to treat another symptom Reporting psychic effects Aggressive complaining about need for higher doses Recurrent prescription losses Stealing or Borrowing another patient’s medications Injecting/snorting oral formulation Heating fentanyl patches Obtaining prescription drugs from non-medical sources Concurrent abuse of related illicit drugs or alcohol/tobacco
- 19. Identify Addiction Risks History and Physical Examination must be performed and documented for every patient for every visit Treatment Plan with goals Evaluate Opioid Requirements Risk Assessment Opioid Risk Tool (http://www.partnersagainstpain.com/printouts/Opioid_Risk_Tool.pdf) Pain Assessment and Documentation Tool (http://healthinsight.org/Internal/assets/SMART/PADT.pdf) Screener and Opioid Assessment for Patients with Pain (http://nationalpaincentre.mcmaster.ca/documents/soap p_r_sample_watermark.pdf)
- 20. Diversion Narcotic pain medication is extremely valuable Do not replace stolen/lost medication No sharing medication No early refills Random Urine Drug Testing Random Pill Counts
- 21. What can we do about it Practice appropriate controlled substance prescribing Opiates are a means to an end not an end by itself Learn about the patient? Why is he asking me for these drugs? Refer to pain management specialists
- 22. Legislation for Puerto Rico Currently, Puerto Rico does not have adequate legislation to address these issues. A local law firm has developed a project of law based on similar legislation in Florida and other states. Local legislation seeks to include a combination of both the electronic monitoring system and the UDT. The electronic monitoring system, based on Florida’s NASPER system, will be administered by the Puerto Rico Department of Health.
- 23. Project of Law Stakeholder Meetings The project of law is championed by the President of the Senate’s Health Committee, the Honorable Senator José Luis Dalmau. The Senator has formally filed a petition in the Senate requesting all of the health related agencies to provide information related to these issues and their costs. Puerto Rico Board of Physicians (CMPR). Puerto Rico Board of Pharmacists (CFPR) Presentation during their national convention (August 2014).
- 24. Project of Law Stakeholder Meetings Puerto Rico State Insurance Fund Corporation (CFSE). Currently under review by the Drug Enforcement Agency (DEA) and the Puerto Rico Health Administration (ASES). The content of the project of law has received general approval except for: The proposed penalties. Requests for a more comprehensive costs-benefits analysis.
- 25. Controlled Substance Agreement Written Agreement, Explaining Risks/Benefits Addiction/Dependence Number and frequency of prescriptions and refills Compliance rules and violation with reasons for termination of therapy CS by a single MD, unless authorized and documented Evaluated every 3 months Monitor efficacy, indications, progress to objectives, adverse effects, review of etiology, modifications, appropriateness of treatment, monitor compliance.
- 26. Summary of Prescription Drug Monitoring Program (PDMP) Prohibits donations of pharmaceutical manufacturers. Not mandatory for a prescriber or dispenser to review PDMP prior to prescribing or dispensing. Data submission -- 7 days for pharmacies and dispensing physicians that dispense CS. The following are exempt from reporting in the PDMP for that specific act of dispensing or administration. When administering a CS directly to a patient if the amount of the CS is adequate to treat the patient during that particular treatment session. A pharmacist or health care practitioner when administering a CS to a patient or resident receiving care as a patient at a hospital, nursing home, ambulatory surgical center, hospice, or intermediate care facility for the developmentally disabled which is licensed in this state.
- 27. PDMP - Goals The PDMP will allow health care practitioners to view all of their patient’s dispensed prescription history that is seven (7) days or later. The practitioner will then be able to check the following to: • Determine • the potential for adverse drug reactions • the best possible therapeutic therapy • patient compliance with practitioner’s guidance • if there are duplicative prescriptions during the same time period • if their patient is “doctor shopping” i.e. seeing multiple physicians within the past thirty (30) days and not telling them they already have a prescription for the same controlled substance(s) • potential for drug to drug or drug to allergy interactions
- 28. URINE DRUG TESTING (UDT) Centers for Medicare and Medicaid (CMS) policy Medical Necessity Who, When, Why Best Practice Protocols
- 29. Urine Toxicology We may be surprised with what we find!
- 30. CMS Policy on Urine Drug Testing (UDT) According to CMS policy – UDT provides objective information to assist clinicians in identifying the presence or absence of drugs or drug classes in the body and assist in making treatment decisions Details of the policy include: Appropriate indications and expected frequency of testing for safe medication management of prescribed substances in risk stratified pain management patients and/or in identifying and treating substance abuse; Designates documentation, by clinicians in the patient’s medical record, or medical necessity for, and testing ordered on an individual patient basis; Provides an overview of presumptive (screening) UDT and definitive UDT testing by various methodologies CMS Policy Number DL35654
- 31. AMA DEFINITION OF MEDICAL NECESSITY Health care services or products that a prudent physician would provide to a patient for the purpose of preventing, diagnosing or treating an illness, injury, disease or its symptoms in a manner that is: • (a) In accordance with generally accepted standards of medical practice; • (b) Clinically appropriate in terms of type, frequency, extent, site, and duration; and • (c) Not primarily for the economic benefit of the health plans and purchasers or for the convenience of the patient, treating physician, or other health care provider.
- 32. ACCORDING TO CMS Services are Reasonable and Necessary if the contractor determines that the service is: Safe and effective; Not experimental or investigational; At least as beneficial as an existing and available medically appropriate alternative; and Meeting, but not exceeding the patient’s need and furnished (a) In accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member; (b) In a setting appropriate to the patient's medical needs and condition; (c) And ordered by qualified personnel.
- 33. Urine Toxicology Random urine testing provides a wealth of information Identifies Illicit Drugs Marijuana Cocaine Heroin Identifies the PRESENCE and CONCENTRATION of medication One of the only ways to combat DIVERSION
- 34. Urine Drug Testing Study In a study investigating urine drug toxicology results in 122 patients receiving chronic opioids over a three year period, aberrant drug-related behaviors were discordant with urine toxicology. 27% of patients with no behavioral issues had an illicit or non-prescribed controlled substance in their urine (Katz & Fanciullo, 2002). Michna (2007) reported on 470 patients where 45% were found to have an illicit drug, a non-prescribed controlled substance, or the absence of the prescribed medication. No clear predictors of abnormal drug screens were identified based on the variables of gender, pain site, type of opioid, opioid dose, number of opioids prescribed, or prescribing physician.
- 35. Who to test: Patients who are: New to your practice and already taking a controlled substance May want you to prescribe a controlled substance Request specific drugs Frequently request refills Display aberrant behavior or frequently report loss of medications
- 36. American Clinical Solutions When to test Test patients when: A patient is newly prescribed a controlled substance There is a major change in the patient’s treatment plan There is observation of aberrant, drug-related behavior Reports from a third-party of drug-related behavior
- 37. Why Test? Influence positive health behaviors after discharge from a hospital or during treatment Deplete clinical variance in rehabilitation Use as a standard of care when prescribing an opioid Decrease hospital visits and re-hospitalization Prevent toxicity / overdose Identify diversion, abuse and addiction Classify risk behaviors (Low, Moderate, High) Decrease medical malpractice of wrongful death from overdose in my practice
- 38. Urine Drug Test Protocols for Prescription Management Test upon initial evaluation if the diagnosis indicates a need to prescribe a pain/psych medication Test all patients on a narcotic as medically necessary for compliance, diversion, suspicion of abuse Test patients who ask for a specific medication other than what physician prescribed them Test patients who have had a lapsed time in visiting your practice for treatment
- 39. Urine Drug Test Protocols for Prescription Management If a patient tests positive for an undisclosed drug/medication, retest and council them at each visit until you can justify improved compliance Test patients who complain of an exacerbation in pain, which might require increase of dosage Test newly discharged hospital patients who have been prescribed a narcotic medication Test your patient prior to a procedure that requires anesthesia to identify harmful substances Utilize an Opioid Treatment Agreement for all patients who present chronic pain and verify they will be coming only to you for treatment and to be prescribed these medications
- 40. Immunoassay Immunoassay - use antibodies to detect the presence of specific drugs or metabolites and are the most common method used for the initial screening process. Advantages - relatively low cost, small sample sizes, and rapid turnaround Disadvantage - relatively low specificity and the potential for receiving false-positive results
- 41. Immunoassay Results of immunoassays are always considered presumptive until confirmed by a laboratory-based test for the specific drug According to CMS policy, LC-MS/MS “is roughly 100 times more sensitive and selective, involves less human steps, provides quicker turn-around time, uses less specimen volume and can test for a larger number of substances simultaneously when compared to GC-MS.” UHPLC-MS/MS (ultra high performance) lab services provide highly sensitive and specific lab-guided medication management that can provide an advanced level of detection in both urine and oral samples to give the support and confidence physicians need for practice, patient and clinical outcome success.
- 42. ICSI, Acute Pain Assessment and Opioid Prescribing Protocol 2014
- 43. Drug Duration in Urine Alcohol (EGT) 3-5 days BDZ 1-6 weeks Cocaine 2-30 days Buprenorphine 1-3 days Codeine, Tramadol and Most Opioids 2-4 days Cotinine (Tobacco) 1-3 days Demerol 6-12 days Heroin 2-4 days Diazepam 7-10 days or up to 6 weeks Ectasy 1-5 days Fentanyl patch 8-24 hours Methylphenidate 1-2 days Morphine 3-4 days Oxycodone/Oxycontin 3-4 days Tylenol #3 Min Use 8-24hrs
- 44. In Conclusion Understand the principles of pain management Best practice Opioid Therapy Management Controlled Substance Agreement with Patient Urine Drug Testing Drug Monitoring Program Identify opioid abuse and diversion tactics Know your patient Documentation to support Medical Necessity for services provided