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11/8/2011 Marc A. Valley, MD, MS, CPE Medical Director Tri States Pain Management Center Enhanced Lifestyle Risks and complications of treatment, including addiction Discuss what makes up a “Pain Patient” Present options to present the condition, the diagnostic work‐up and the treatment of the condition to the patient Present a quick overview of nonmedical use of Present a q ick o er ie of nonmedical se of prescription opioids Discuss factors that contribute to the problem in chronic pain management for clinicians and patients Discuss a Risk Management system to minimize the problems in chronic pain management 1 11/8/2011 Abuse‐ a maladaptive pattern of substance use leading to clinically significant impairment or distress1 Diversion‐ the shifting of legally obtainable h hf fl ll b bl drugs into illegal channels or the acquisition of a controlled substance by an illegal method2 1. American Psychiatric Association. DSM‐IV‐TR. American Psychiatric Publications Group; 2000:198‐199. 2. Adapted from Palm Beach Sheriff’s Office‐ Prescription Fraud/Drug Diversion Division. Tolerance‐ The development of physical and/or psychological resistance to the effects of a medication Dependency‐ d The physical and/or h h l d psychological need to the continue the medication to prevent withdrawal Addiction‐ The social/legal maladaptive behavior to prevent withdrawal At 3:00 PM you walk into your office’s examination room to meet John Smith, a 45 year old male. Mr. Smith has a 15 year history of chronic back pain He has had multiple back surgeries He is currently on Lortab 10/650, 5 to 7 per day He has been seen in “multiple clinics that didn’t help me…” 2 11/8/2011 Did the patient bring any previous records: INTERACTION: No This is when you tell the patient what you are, a healthcare professional, that your goal is to appropriately diagnose and treat him, which will require obtaining a history, performing a physical examination and obtaining appropriate diagnostic tests and consults. Order appropriate diagnostic tests and consultations INTERACTION: Explain what you are doing and why Discuss the risks and complications of nonopiate medications: ▪ Antidepressants ▪ Anticonvulsants Discuss the risks and complications of opiate medications 3 11/8/2011 Between 1992 and 2003 The U.S. population increased 14% Prescriptions written for controlled substances increased 150% Incidence of new starts of prescription opioid abuse in teenagers increased 542% Adapted from Manchikanti L. Pain Physician. 2006;9:287‐321 Of all ED visits due to nonmedical use of prescription or OTC pharmaceuticals in 2004, 1 out of 4 were due to opioid analgesics Of these, oxycodone and hydrocodone accounted for about 60% 4 11/8/2011 Opiate Risk Tool Family history of substance abuse: Alcohol, Illegal drugs, prescription drugs Personal history of substance abuse Age History of preadolescent sexual abuse Psychological Disease: Depression, Bipolar, etc. REFERENCE: Webster LR, Webster RM. Predicting aberrant behaviors in opiate treated patients: preliminary validation of the opiate risk tool. Pain Med. 2005;6:432‐442. DIRE: Diagnosis, Intractability, Risk and Efficacy. 1 = Benign chronic condition with minimal objective findings or no definite medical diagnosis: fibromyalgia, migraine headaches, non‐specific back pain. 2 = Slowly progressive condition concordant with moderate pain, or fixed condition with moderate objective findings. Examples: failed back surgery syndrome, back pain with moderate degenerative changes, neuropathic pain. 3 = Advanced condition concordant with severe pain with objective findings: ischemic vascular disease, advanced neuropathy, spinal stenosis. 5 11/8/2011 1 = Few therapies have been tried and the patient takes a passive role in his/her pain management process. 2 = Most customary treatments have been tried but the patient is not fully engaged in the pain management process, or barriers prevent (insurance, transportation, medical illness). 3 = Patient fully engaged in a spectrum of appropriate treatments but with inadequate response. 1 = Serious personality dysfunction or mental illness interfering with care. Example: personality disorder, severe affective disorder, significant personality issues. personality issues 2 = Personality or mental health interferes moderately. Example: depression or anxiety disorder. 3 = Good communication with clinic. No significant personality dysfunction or mental illness. 1 = Active or very recent use of illicit drugs, excessive alcohol, or prescription drug abuse. 2 = Chemical coper (uses medications to cope with stress) or history of chemical h h f h l dependence (CD) in remission. 3 = No CD history. Not drug‐focused or chemically reliant. 6 11/8/2011 1 = History of numerous problems: medication misuse, missed appointments, rarely follows through. 2 = Occasional difficulties with compliance, l d ff l h l but generally reliable. 3 = Highly reliable patient with meds, appointments & treatment. 1 = Life in chaos. Little family support and few close relationships. Loss of most normal life roles. 2 = Reduction in some relationships and life d l h dlf roles. 3 = Supportive family/close relationships. Involved in work or school and no social isolation. 1 = Poor function or minimal pain relief despite moderate to high doses. 2 = Moderate benefit with function improved in a number of ways (or insufficient info – b f ff f hasn’t tried opioid yet or very low doses or too short of a trial). 3 = Good improvement in pain and function and quality of life with stable doses over time. 7 11/8/2011 Score 7‐13: Not a suitable candidate for long‐term opioid analgesia Score 14‐21: May be a good candidate for long‐term opioid analgesia l i id l i References: Belgrade MJ, Schamber CD, Lindgren BR. The DIRE Score: Predicting outcomes of opioid prescribing for chronic pain. J. Pain. 2006;7:671‐681. Drug Abuse Screening Test 28 item yes‐or‐no self reporting screening test. References: f Yudko dk E, Lozhkina hk O, Fouts A. A comprehensive review of the psychometric properties of the Drug Abuse Screening Test. J Subst Abuse Treat. 2007;32:189‐198. Emerging Solutions in Pain www.emergingsolutionsinpain.com Excellent source of information, including references, tools and discussion groups regarding chronic pain management Register and download tools as PDF files Beneficial in documenting continued monitoring of patients. 8 11/8/2011 For the sake of the discussion, you decide to continue treatment using opioids in this patient. Following are some issues to consider ll d NSAIDs Sustained‐release opioids Adjunctive medications (Antidepressants, anticonvulsants, major tranquilizers) l l Radiation Therapy Chemotherapy Implanted pain pumps cost effective if estimated life expectancy greater than 4 months Patients will get tolerant and dependent to opioids‐ high doses often required NEVER use meperidine REMEMBER that nerve destruction is often a h d f safer alternative REMEMBER‐ in a terminal patient pain control is more important than addiction risk Always consider diversion from patient to family members 9 11/8/2011 I hate combination medications‐ Oxycodine is better than Oxycodone/APAP I hate Oxycodone‐SR – recent formulation has minimal diversion risk h ld k I love medications with no street value‐ but they all do‐ even suboxone Start LOW and go SLOW; and when converting from one agent to another, assume a lower dose An excellent, cost effective option, BUT… Remember, multiple problems: half life of side effects longer than analgesic half life‐ do not change doses any more frequently that once a week. Can cause lethal cardiac dysrhythmias Can cause respiratory depression Bottom Line‐ in my opinion, should only be used by pain management physicians Risk Management is a process of… Assessing a product’s benefit‐risk balance Developing strategies and implementing tools to minimize risk and preserve benefits for the patient and the clinician Reassessing a product’s benefit‐risk balance and evaluating tool effectiveness Adjusting, as appropriate, the risk‐minimization tools to further improve the benefit‐risk balance 10 11/8/2011 Step 1: Subjective (patient history) Step 2: Objective (physical exam and data) Step 3: Assessment Step 4: Plan (document treatment goals and l d l d treatment agreement) Step 5: Implementation Step 6: Monitor (UDS, patient work and ADLs) Step 7: Return and review outcomes Starr TF, et al. Substance abuse in cancer pain. Curr Pain Headache Rep. 2010;14:268‐275. The use of chronic long term opiates have enhanced life quality in cancer patients Most addictions present prior to age 35; cancer patients are usually older and therefore have less risk However, younger patients are being diagnosed Many patients are surviving cancer, yet continue to have chronic pain‐ neuropathic, visceral and soft tissue Therefore, use screening tools Manchinkanti L, et al. A systematic review of randomized trials of long‐term opioid management for chronic non‐cancer pain. Pain Physician 2011;14:91 2011;14:91‐121 121. Other than for patients with osteoarthritis treated with tramadol, the use of chronic long term opiates do not enhance function or pain scores in non‐cancer pain patients. Non randomized trials do not support the long‐ term use of chronic opioid therapy except in individual patients. 11 11/8/2011 Manchinkanti L, et al. Breakthrough pain in chronic non‐cancer pain: Fact, fiction, or abuse? Pain Physician 2011;14:E103‐E117. The use of short acting “breakthrough” medications do not enhance pain control Solanki DR, et. Al. Monitoring opioid adherance in chronic pain patients: Assessment of risk of substance misuse. Pain Physician 2011;14:E119‐E131. h Poor literature support for a single screening tool Pill count is a poor option ▪ Most patients can obtain street drugs to cover their counts quickly and easily Random and Directed UDS may be best option, if used and reviewed correctly Urine testing does not enhance appropriate medication use (patients game the system) The only system that works in decreasing opiate diversion in the physician practice is d h h the State Pharmacy Board report Problem: In Southwest Virginia, registration in TN, WV, KY, VA and NC is necessary Call your congressman and urge them to support re‐authorization and funding of NASPER 12 11/8/2011 Sharing with family and friends Doctor shopping Drug hoarding Prescription forgery or alteration (quantity f l manipulation, “script washing”) Prescriptions for favors exchanged Exaggerating symptons to obtain increased opioid doses Dispensing without prescription (eg, internet pharmacies) Fraud (“pill mills”) Illegal substitutions or shorting prescription ll l b h amounts (pharmacist, caregiver) Clinicians prescribing to friends and family members Pharmacy and home theft 1. During pain clinic visits, the patient displays an overwhelming focus that persists beyond the third clinic treatment session, on opiate issues to such an extent that this focus h h h f occupies a significant portion of the visit, impeding progress with other issues regarding the patient’s pain. 13 11/8/2011 2. The patient has a clear pattern of ≥3 early refills or has an escalating drug use in the absence of any acute changes in his/her medical condition. d l d 3. The patient generates multiple visits or telephone calls to the pain clinic’s administrative office to request more opiates, early refills, or discuss problems associated with his/her opiate prescription. 3 continued. A patient may qualify with fewer visits if he/she causes a disturbance with the pain clinic’s staff. 4. The patient has a pattern of prescription h h f problems for a variety of reasons including lost, spilled or stolen medications. 5. The patient has supplemental sources of opiates obtained from multiple providers, emergency rooms (ER), or illegal drug sources. Patient proves to be a poor candidate for chronic opioid use. Now What? Option One: Immediately terminate Option Two: ▪ Rationally explain what happened and why patient is no longer a candidate for chronic opioids ▪ Discuss other options: Referral for detoxification, a pain management clinic, etc. ▪ Use objective, non‐confrontational methods of communication 14 11/8/2011 BUT Lack of Awareness <20% of clinicians received any medical school training in identifying prescription drug diversion <40% received any training in medical school in identifying prescription drug abuse and addiction Inadequate Risk Management 43% do not ask about prescription drug abuse as part of patient history 33% do not request records from previous providers for new patients Inadequate Treatment of Patients 74% have not prescribed a controlled substance due to concern about patient abuse in the past year Marc Valley Email: [email protected] Office: To Be Determined Fax: To Be Determined Cell: 423-631-6842 15