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MEDICATIONS OF CONTROVERSY Challenges, Risks and Strategies Alan Lembitz M.D. COPIC © 2006 Wotkyns Creative Disclosure I have no relevant financial relationships to disclose Risks OverviewToday we are going to talk about: Scope of Problem Safe prescribing practices Tools- PDMP, Agreements, Consents, Screening Tools, Diagnostic Tools, Documentation PART 1 OPIOIDS 5 Being a medical caregiver means putting your self in suffering’s way Rita Charon M.D. 6 CDC declares painkillers at epidemic levels Opioids, Anxiolytics and Sedatives Rates of prescription painkiller sales, deaths and substance abuse treatment admissions (1999-2010) SOURCES: National Vital Statistics System, 1999-2008; Automation of Reports and Consolidated Orders System (ARCOS) of the Drug Enforcement Administration (DEA), 1999-2010; Treatment Episode Data Set, 1999-2009 Distribution of Opioid Users Controlled chronic pain “All the rest” uncontrolled pain pseudo-addiction Addiction abuse Overview Top Reasons for paid claims in Primary Care: 1 2 3 Delay or failure to diagnose (65+%) Improper treatment of known medical condition Medication Errors 10 Risk by diagnosis Heads Hearts Bellies Bugs- Severe Infectious Diseases Failure to DX CA Underappreciated severity of trauma COPIC data OxyContin in increasing doses beginning at ½ tab TID (20 mg) and increasing to 80mg tabs 6 per day in 4 doses – These are the complete notes Opiates Opiates from poppies Sumerians isolated opium from 3000 B.C. Given with hemlock to put people to death China 800 AD Europe 1300 13 Opiates In 1806 Serturner isolated the morphine alkaloid and named it after the god of dreams, Morpheus Heroin detailed for cough medicine in 1898 Works thru at least 4 receptors throughout the body Profound effect is the mu receptor CNS Controlled Substances Act in 1970 DEA enforces 14 Be sure of the DX Pain out of proportion to findings ? FX ? Necrotizing fasciitis Vascular, inc. mesenteric Compartment syndrome Don’t miss the CA Pain diagrams Accuracy of diagnosis Symptom magnification Objective preprocedure, or pretreatment functionality Objective postprocedure or posttreatment assessment of functionality 16 Addiction vs. tolerance vs. dependence Addiction Tolerance Physical dependence Compulsive use causing personal harm Decreased effectiveness over time Abstinence syndrome think French connection Psychological dependence Actually rare - if more needs there may be a reason Not psychologic addiction Rare in terminally ill or pain management Usually preexisting abuse Don’t label a tolerant patient addicted Decrease dose 50% Q 3 days Addiction A maladaptive pattern of substance use leading to impairment or distress, but has not met the criteria for Substance Dependence, having ≥ 1 of the following: Recurrent substance use resulting in failure to fulfill major role obligations at work, home, school Recurrent substance use in situations in which it is physically hazardous Recurrent substance-related legal problems Continued substance use despite having persistent or recurrent problems caused by the substance use 18 Opioid addiction risk factors Biggest risk factor is a personal or family history of drug/ETOH abuse Psych problems Poor coping skills Sexual abuse Journal of pain v109 pg 113-130 2009 19 Faces of addiction Criteria of chronic illness Genetics Pathogenesis Precipitants Environmental determinants Gender specifics Complications Relapse-Remission Key to identifying alcohol abuse ASK • CAGE: cut back, annoying, guilt, eye opener • Drinks per week: 7 or 14? • Binge per year: 5 (4)? SOAPP Biggest risk factor is a personal or family history of drug/ETOH abuse Journal of pain v109 pg 113-130 2009 23 Overdose- accidental vs. intentional It’s about the documentation Evaluate for coexisting psych problem Tip of the iceberg potential ACTIONS MUST MATCH THE DOCUMENTATION DEA Responsible prescribing Regulation increasing Stings Documentation Pharmacist is the trigger work with them Street value Drug Estimated Street Cost Oxycodone $5-10/ pill Oxycodone ER $1/mg Vicodin 5/500 $3-5/ pill Percocet $5-10/ pill Methadone $25 Xanax $3-5/ pill Fentanyl $1/ mcg 26 Dilaudid 4mg #240 No address No date Pm No legitimate purpose Street value of this Rx: $7,000 plus Prescription Drug Monitoring Program Powerful tool Use it don’t lose it Password sacred Notification 28 Which of the following is NOT appropriate for a pain agreement? A) No diversion allowed B) May request a tox screen at any time C) Notify us by Thursday if scripts are lost or destroyed D) Can only go to 1 pharmacy 29 Opioid agreements An Agreement not a Contract May specify one pharmacy Treaters may discuss DX and RX No diversion Danger of abrupt withdrawal Pregnancy Urine or Serum tox screens may be a condition of the agreement. Lost, wet, left, stolen not acceptable excuses Compliance with scheduled appointments and referrals Breach may result in termination, cessation of therapy or referral to addiction specialist Long-term consent Indications Withdrawal Risks Addiction definition and potential Prohibition of activity if impaired Physical Dependence Tolerance and Possible Increases in dosages or reduction in effect 32 Align your partners Clear discussion of philosophy Pain agreements help guide your partners A covering prescriber on a routine script- little risk CMB – red flags Chronic narcotics without cause No formal relationship No physical exam Suggest different pharmacies Prescribe for sex or sharing Prescribe to family Example of the office visit notes OxyContin 40mg 2-bid Dilaudid 8mg qid Soma 1 qid DEA examples New patient: Prescribed Dilaudid 4 mg #240 plus Xanax Do you believe this doctor did an exam of the head, heart and lungs? Hassle factors HIPAA Records release Labeling addict can be an issue Weekend and night calls Always Contact the previous physician Ask the patient about previous alcohol and drug use, or psychiatric or drug related hospitalizations. Document a thorough and thoughtful exam Consider a drug screen PART 2 MEDICAL MARIJUANA RECREATIONAL MARIJUANA 41 SCOPE OF MMJ Numbers of registrants Characteristics of registrants Age Primary Dx The Dispensaries MAJOR QUESTIONS TO CONSIDER Do I certify for MMJ? Informed Consent Screen for contraindications Know and review the science Following CMB regulations Bona fide physician patient relationship Diagnosis established by history and examination Documentation Recommendation for follow-up Practical Logistics- forms and registry MAJOR QUESTIONS TO CONSIDER My patient is on MMJ registry and actively using, does this change my practice and prescribing for them? MAJOR QUESTIONS TO CONSIDER What if my patient was inappropriately certified for the registry? CMB unprofessional conduct- license and duty to report Specific clinical examples Minors Psychiatric contraindications Occupations involving public safety MAJOR QUESTIONS TO CONSIDER Do I have vicarious liability if I certify, or if I know my patient is using MMJ, or if they are taking opioids, etc? Chart documentation of discussion Informed consent is a process, but a form may be required if significant risk and non-compliance with recommendations DRIVING UNDER INFLUENCE Law Enforcement considerations Available testing and reliability SPECIAL SITUATIONS Physicians who personally are on the registry CPHP CMB COPIC SUMMARY Certifying my own patients- how to do this in compliance and consistent with sound medical practice What to do about your patient who someone else certified for the registry What about other physicians who certify out of compliance with sound practice Vicarious liability DUI is not just alcohol Boundaries- Are your issue Boundary discussions are often about your own conflict Can be you or the patient with the problem Discuss what your concern is Boundaries—Providers role I don’t give unlimited narcotics but I want to help you. What can we work out…. Clarify boundaries And negotiate My role is to help people not just give out narcs… Can we come up with a short term plan today and then work on something long term? Do you accept the challenge? Do you choose to work with this patient? It is OK to say no Send a letter 30 days Taper schedule Withdrawal and ? refer The good news Most lawsuits result in defense judgments or verdicts. Most patient complaints to plaintiffs’ attorneys do not result in lawsuits Most CMB complaints do not result in discipline Pain assessments, agreements, consents, documentation and consults help greatly 53 Our challenge "....in the sufferer, let me see only the human being” – Maimonides, 13th Century Thank you I appreciate your feedback. Any questions? Alan Lembitz M.D. VP, COPIC Patient Safety and Risk Management 55