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American Osteopathic College of Occupational and Preventive Medicine 2015 Mid Year Educational Conference, Ft. Lauderdale, Florida

Guidelines and Recommendations “Federal and State Laws Relating to the 1. Standards For The Use Of Controlled Substances Prescribing of Controlled Substances”. For Treatment Of ; AHCA in consultation with The Florida Pain Commission, The Florida Board of • Walter B. Flesner III, D.O. Medicine, and The Florida Board of Osteopathic • Past President, FOMA, 1996-1997. Medicine, Revised 12-21-99. 2. JCAHO Standards 1999 3. Federation of State Medical Boards Joint Concensus • Past President, FOMA District XI, 2008-2010. 4. Federal Controlled Substances Act 1970 • Medical Director, ICP&R, Cape Coral, Fl. 5. DEA Statements. • Risk Management/Continuing Medical Education 6. Florida House/Senate Bills 7095,0462, and 2272, Florida Statute Chapter 893, 456.44, 459.0137,64B- American Osteopathic College of Occupational and 15-14.005. 7.Risk Evaluation Preventive Medicine Midyear Seminar. and Mitigation Strategy 8.E-Forcse-PDMP. 9. • Sunday, Sunday March 15th, Ft. Lauderdale, Fl. Lee County Coalition for a Drug-Free South West Florida.

Walter B. Flesner III, D.O. Medical Director ICP&R Florida Statistics • 7 Floridians die daily from lethal overdoses. Additional 7 persons die daily with at least one prescription drug detected in combination with Addressing Prescription or other drugs. Florida led nation in sale of Pain Medicine Abuse & Misuse: with over 400,000,000 pills sold A Framework For Safe Prescribing annually! However down 20% in past year. How Prescription Drugs get to Floridians: 1. Physicians and Pharmacists- for profit, naïve, impaired. 2. Individuals- illegally obtain to satisfy addiction, traffic or divert for profit or to family or friend. 1. 3. Internet pharmacies- major difficult threat.

Z-1 American Osteopathic College of Occupational and Preventive Medicine 2015 Mid Year Educational Conference, Ft. Lauderdale, Florida

Solutions Be part of the solution, not part of the problem. You are here! Learn new guidelines, talk to your colleagues, consult specialists when indicated. Florida BOM, FBM, DEA, FDLA, State, County, Local law enforcement, State Attorney’s Off., FOMA, FMA, Specialty Societies- we all need to work together so legitimate acute, chronic, and terminal pain patients can have appropriate access to compassionate and multidisciplinary care. Urine drug testing, the Prescription Drug Monitoring Program (PDMP)- E-FORCSE.com, and patient-doctor agreements have started to help. New Zoning Laws are coming for new Pain Clinics.

Definition of Pain Definitions

IASP definition:* • Tolerance Pain is “an unpleasant sensory and emotional experience Pseudotolerance associated with actual or potential tissue injury or Physical Dependence described in terms of such damage.” Addiction Importance of the patient’s self-report: Pseudoaddiction “Pain is whatever the experiencing person says it is, Substance Abuse existing whenever he/she says it does.”** Acute Pain

* IASP. Pain 1979;6:249-252. ** McCaffery M, Beebe A. Pain: Clinical Manual for Nursing Practice. St Louis: CV Mosby Company; 1989.

Tolerance: Pseudotolerance:

• the need for increased dosage of • need to increase dosage is not due to to produce same level of analgesia that tolerance, but due to other factors such as existed previously. Tolerance occurs also when progression, increased activity, drug a reduced effect is observed with constant interaction, new disease, other medication doses. tolerance is not always seen changes, or deviant behavior. during opioid treatment and is not addiction.

Z-2 American Osteopathic College of Occupational and Preventive Medicine 2015 Mid Year Educational Conference, Ft. Lauderdale, Florida

Physical dependence: Addiction:

• Occurrence of withdrawal • psychological dependence on the use of symptom/syndromes after opioid use is substances and their psychic effects and/or stopped abruptly or decreased without compulsive use of drugs over which patients titration. It can also occur if an antagonist is no longer have control, and continue to use administered. Physical dependence is NOT despite harm to themselves or others. addiction! It does not always occur with Addiction is a disease. opioid usage, but is a common phenomenon with opioid treatment.

Pseudoaddiction:

• drug-seeking behavior that may seem similar to addiction, but is due to unrelieved or incompletely relieved pain. Often after a dosage increase, the behavior stops once the pain is relieved.

Substance Abuse: Acute Pain:

• use of any substance for non-therapeutic • normal predicted physiological response to an purposes. adverse chemical, thermal, or mechanical stimulus and is associated with trauma, surgery, or acute illness. It usually resolves within 3 months. • Subacute Pain: 3-6 months. • Chronic pain: > 3-6 months.

Z-3 American Osteopathic College of Occupational and Preventive Medicine 2015 Mid Year Educational Conference, Ft. Lauderdale, Florida

Keys to Appropriate Pain Chronic Pain: Assessment • Complete initial assessment • • state in which pain is persistent and cannot be Use appropriate tools removed or otherwise cured. It usually has – patient self-report occurred for more than 6 months. – easily administered rating scales 456.44: Chronic nonmalignant pain means pain – documentation forms available to all clinicians: Pain unrelated to cancer or rheumatoid arthritis which Assessment and Documentation Tool/ PADT, Opioid Risk persists beyond the usual course of disease or the Tool, Screener and Opioid Assessment for Patients with Pain/SOAPP. injury that is the cause of the pain or more than • 90 days after surgery. Assess pain at regular intervals • Be aware of common pain syndromes • Risk Identification and Stratification

Initial Pain Assessment: Medical History Initial or Ongoing Pain Assessment: Characterization of • Extent of disease Pain • Previous therapies: effective & failures • Location • Description • Treatment-related signs and • Intensity symptoms • Temporal nature • Other medical conditions – onset • Efficacy of previous – duration – chronic/acute/palliative therapy relationship to scheduled analgesic dose • Aggravating/alleviating factors • Efficacy of previous analgesic treatments • Effects on function

Initial Pain Assessment: Initial Pain Assessment: Psychosocial Examination Physical Examination and Diagnostic Studies • Disease state: effects and understanding • Physical Examination: • Reactions to pain – Site of pain – meaning of pain – Adjacent sites (for ) – coping strategies and support system – Sites of known disease/ tumor invasion – effects on function – effects on mood – Musculoskeletal and neurologic systems • Perceptions regarding analgesic therapy • Diagnostic Evaluation: – expectations, knowledge, and preferences – Laboratory studies/tumor markers – concerns regarding controlled substances – Radiologic studies • Financial concerns regarding therapy – Neurophysiologic testing *Assess whether low, medium, or high risk for abuse for – Urine drug screening chronic opioid therapy (COT).

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Pain Assessment Tools: Intensity

Simple Descriptive Pain Intensity Scale 0-10 Numeric Pain Intensity Scale 0 10 None Mild Moderate Severe Very Worst Severe Possible

0-10 Numeric Pain Intensity Scale 0 10 0 1 2 3 4 5 6 7 8 9 10 None Moderate Worst Possible

Visual Analog Scale (VAS) 0 10 None Pain as bad as it could possibly be

Faces scale reprinted with permission from Patt RB. . Philadelphia: JB Lippincott Co.; 1993. Jacox A, et al. Management of Cancer Pain: Clinical Guideline No. 9. March 1994. AHCPR Publication No. 94-0592.

SCREENER and OPIOID ASSESSMENT for PATIENTS with PAIN ( SOAPP), PAIN ASSESSMENT and DOCUMENTATION TOOL (PADT). OPIOID RISK TOOL. • SOAPP version 1.0 is an easy and relatively quick questionnaire to help physicians and providers evaluate patients’ risk for higher problems if long-term opioid therapy is to be considered. SOAPP is not a lie detector test. It is not intended for all patients. It is likely to predict which patients will need less or more close monitoring on long-term opioid therapy. Version 1.0 has 24 questions. Version 1.0 SF has 5 questions. 2 most important questions-Smoke and drink? PADT- Useful tool for clinicians evaluating care and outcomes during opioid therapy. Also Opioid Risk Tool.

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Pharmacologic Management of Pain • Select the appropriate Drug. • Prescribe the appropriate Dose- do under or over treat. • Administer by the appropriate Route. • Schedule the appropriate dosing Interval- consider long acting for ATC, short acting for rescue/breakthrough. • Prevent Persistent pain/relieve Breakthrough pain. • Titrate doses aggressively. • Anticipate, prevent, and manage the Side Effects. • Use appropriate Adjuvant drugs when indicated. • Assess treatment response at regular intervals.

Adapted from Levy MH. N Engl J Med 1996;335:1125.

opioid Choice of Agent: The word opioid is a general term that Three-Step Analgesic Ladder refers to all compounds related to

Morphine . The term narcotic(causing Opioid + Adjuvant Oxycodone narcosis) once used to refer to any Moderate/Severe 3 g + Nonopioid n i s a e

r drug that induced sleep, is currently c n i r

o Opioid often

Dihydrocodeine used in a legal context to refer to a g wWHOWith n

i t

Mild/Moderate 2 s Nonopioid i Oxycodone s

r + Adjuvant variety of substances not restricted to e p

n AAPAPcetamino i a phen with abuse or addictive P NAPAPonoA /NSAID’s Mild 1 Ppioid + potential. DO NOT use these terms Adjuvant COX II’sA interchangeably.

Opioid Classification Naturally Occurring Opioids

• Naturally occuring Opioids Semisynthetic Opioids • Synthetic Opioids Codeine Thebaine

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Semisynthetic Opioids Synthetic opioids • Hydrocodone Hydromorphone Oxycodone • Meperidine Fentanyl • Tramadol- Atypical; Thought to be synthetic but in bark of S. African tree.

Schedule I Opioids

Controlled Substances Act of 1970 • Marijuana-Federal Heroin (In 1898 Bayer Chemical Co. of Congress- Legislation Germany introduces diacetylmorphine, naming it “Heroin”) LSD

Schedule II Opioids Schedule I • Morphine Codeine NO PRESCRIBING ALLOWED! Hydromorphone Even in California!! Oxymorphone Current acceptable medical uses?- Oxycodone, Oxycodone/acetaminophen, not in current form. Oxycodone/ Very high potential for abuse and • Fentanyl addiction. Meperidine Medical marijuana is controversial. Methadone • Hydrocodone without APAP-new. *Hydrocodone - all versions: DEA just announced Hydrocodone with is Schedule II as of 10-1-14.

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Schedule II. Methadone Fentanyl- Actiq and Duragesic Methadone is prescribed for chronic pain states Demerol (Meperidine)-Avoid! Toxic metabolite after 3 days. Dilaudid (Hydromorphone). including , somatic pain, visceral pain Morphine (Astromorph, Duramorph, Infumorph, Kadian, ,cancer pain, and sickle cell pain. MS Contin, MS-IR, Oramorph, Roxanol). Most common dose is three times daily. Oxycodone ( Oxyfast, OX-IR, Roxicodone, Oxycontin, Percocet, Methadone lacks active metabolites, has high level of Percodan, Tylox). bioavailability, is inexpensive, and exhibits Levo-Dromorphan (). Numorphan (Oxymorphone). antagonistic activity at N-Methyl-D-Aspartate Methadone. receptors. Be careful of lethargy and Opana/Opana-ER (Oxymorphone) hypersomnolence. Do not use for rescue or Nucynta,Nucynta-ER breakthrough pain. Do not use unless you have a lot Hydrocodone/Hydrocodone long acting without of experience. APAP/Zohydro-ER, Hydrocodone combinations. *Long acting for around the clock/ chronic pain; rapid acting for rescue/breakthrough pain.

Schedule II- Prescribing Schedule III Opioids/Combinations

• Written only, partial filling permitted in • Codeine with acetaminophen certain circumstances (may be transmitted Hydrocodone with acetaminophen-Now II. via fax in certain circumstances). Hydrocodone with ibuprofen- Now II. No refills permitted. Hydrocodone-containing elixirs-Now II. High potential for abuse Buprenorphine film, tablets, and patch(used to be Class V)

Schedule III. Schedule III Prescribing

• No longer III: Hydrocodone-acetaminophen • Written, oral (promptly reduced to writing by combinations- (Hydrocet, Lorcet, Lortabs, pharmacist), partial filling permitted (may be Vicodin/-ES/-HP, Norco)-all II. transmitted by fax). Tylenol with Codeine 3 & 4 Must be filled/refilled within 6 months of No longer III: Hydrocodone/Ibuprophen issuance and can be refilled no more than 5 Vicoprofen)-now II. times within those 6 months. • Suboxone/ Buprenorphine-III. Moderate abuse potential.

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DEA Controls Tramadol as schedule Schedule IV- Not just opioids IV effective August 18, 2014. • Federal Registry- 79 Fed Reg 37,623. July 2, Stadol Nasal Spray 2014. Phenobarbital • Tramadol now schedule IV. Benzodiazepines • Central acting atypical opioid analgesic. Sedative hypnotics • Serotonin-norepinephrine reuptake inhibitor. Phentermine • Once thought synthetic opioid however found Tramadol-as of 8-18-2014 per DEA. in bark of tree. Talwin: Pentazocine/Naloxone / Lyrica: Schedule V.

Model Policy for the Use of Schedule IV Prescribing Controlled Substances for the • Written, oral (promptly reduced to writing Treatment of Pain by pharmacist), partial filling permitted (may be transmitted by fax). Must be filled/refilled within 6 months of • Federation of State Medical Boards issuance and can be refilled no more than 5 of the United States, Inc., times within those 6 months. approved May 2004. Lower abuse potential.

DEA Policy Statement on Dispensing Federation of State Medical Controlled Substances for the Treatment of ’ Boards Model Policy Pain • Introduction • It recognizes the importance of with Section I: Preamble Section II: Guidelines controlled substances. Evaluation of the Patient, Treatment Plan, It does not have a campaign to target physicians who Informed Consent and Agreement for Treatment prescribe controlled substances for pain for legitimate Periodic Review medical reasons. Consultation Physicians should not curb legitimate prescribing to avoid Medical Records legal liability or under-prescribing might occur. Diversion Compliance with Controlled Substances Laws and is a serious problem and physicians have an obligation to Regulations take reasonable measures to prevent diversion, misuse, Section III: Definitions- Acute Pain, Addiction, and abuse. ER visits associated with misuse/abuse and Chronic Pain, Pain, Physical Dependence, Pseudoaddiction, Substance Abuse, Tolerance. nonmedical use have alarmingly escalated.

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DEA Continued.. DEA Concluded. • DEA continues to have legal obligation to investigate the extremely low percentage Proposed “90 Day supply rule for stable low-risk patients. of physicians who use their DEA registration to commit criminal acts or otherwise The DEA’s authorityunder the CSA is not equivalent to that of State violate the CSA. Recurring Medical Boards. patterns indicative of diversion, misuse, and abuse. 1. An inordinately large quantity of controlled substances prescribed. DEA does not regulate the general practice of medicine, nor is 2. Large numbers of prescriptions issued. responsible for educating and training physicians so that they make 3.No physical exam was given (medical necessity not established). 4.Physician told patient to fill prescriptions at different pharmacies. sound medical decisions in treating pain. This responsibility lies with 5. Physician issued prescriptions knowing that patient was delivering drugs to medical schools, post graduate programs, state accrediting bodies, others. specialty societies, and state and national medical associations with 6. Physician prescribed controlled drugs at intervals inconsistent with legitimate medical treatment. medical expertise. DEA has neither legal authority nor the expertise to 7. Physician uses “street slang” rather than medical terms for medication provide medical training to physicians or issue guidelines that prescribed. constitute medical advice. The 8. No logical relationship between the drugs prescribed and treatment of condition allegedly existing. majority of cases in which physicians lose their DEA registrations result 9.Physician wrote more than one prescription on multiple occasions in order to from cases referred by State Medical Boards to revoke or suspend the spread them out. ’ Most cases demonstrate blatant criminal conduct. physicians state medical license. Most common ways controlled substances are diverted: Family and friends, ease of Most licenses are not well defended due to lack of or poorquality access via internet, improper prescribing. If patient has urine drug screen with THC- do not prescribe opioid treatment per medical records. DEA agent!

Informed Consent/ Patient- Medical Records • 1. Medical history and physical exam-initially Physician Agreement complete • 1. Risks and Benefits of use of controlled 2. Diagnostic, therapeutic, and lab tests. substances. 3. Evaluations and Consultations. 2.Obtain Opioids/Controlled Substances 4. Treatment goals-decrease pain, increase from one physician and fill Rx’s at activity, improve quality of life. preferably one or at the most two 5. Risk/Benefit discussion 6. Informed Consent/Patient-Physician pharmacies. Agreement. 3. Urine/Serum Drug tests when requested, 7. Treatments-Psychotherapy, PT, Interventional unannounced at least twice yearly, more 8. . often if moderate/high risk. 9. Instructions and directions. 4. Reasons for discontinuation of treatment 10. Periodic/ Regular reviews. At least every 3 (dismissal from practice/care). Months-low risk, more often-moderate risk, comanage/refer-high risk.

Medical Practice Guidelines for practitioners licensed under Guidelines/Standards…. Florida Statutes Chapters 458 or • 1. Pain management principles- 459. documentation is essential! • Standards for the Use of Controlled 2. Definitions. Substances for the Treatment of Pain- Joint 3. Standards-very similar to “Federation…” Consensus of AHCA, The Florida Pain Guidelines. Commission, The Florida Board of Medicine, and the Florida Board of Osteopathic Medicine. Initially Adopted 12- 21-99, Amended 11-10-02, and 10-19-03, New Statutes 2011-2012.

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Florida Rule 64 b 15-14.005 Dec. 2005 State of Florida Dept. of Health • Patients maintained on controlled substances, Class II & III, should comply with the following guidelines: Board of Osteopathic Medicine Medical records- Physician’s medical record must indicate accurate diagnosis, need for long duration of pain Florida Statute 459, 458 Florida management medication. History, Physical exam, and Plan of care and Goals in each evaluation. Board of Medicine, and Rule Diagnostic and/or radiologic test results indicate accurate Chapter 64B15 diagnosis and need for long duration of pain management. X-Ray Annually, Ct scan or MRI within 1 year. Comprehensive metabolic profile (CMP) and CBC every 12 months. ESR, Rheumatoid and Hepatitis profiles in Similar recommendations. appropriate patients annually.

Medical Records Compliance US CONGRESS Approves Office of National Treatment/Medication is prescribed after: Drug Control Policy Reauthorization Act of Documented history and physical. 2006 Assessment of physical and psychological impact of • Contains provision that increases buprenorphine pain. * Assess Low-Medium-High risk patient . prescribing limit from 30 to 100 patients per waived History of/or potential substance abuse,* low-med-hi! physician. Increases access to opioid addiction Coexisting disease/comorbidities. treatment. If patients are taking opioids for Recognized medical indication for controlled substance. nonmedical purposes or are physically dependent Written treatment plan, individualized for patient. or abusing opioids, Suboxone may be an option. Treatment progress and success evaluated • Suboxone is now approved for both induction and objectively: Pain relief, improved physical and maintenance treatment of opioid dependence. psychosocial functioning. REMS is necessary to ensure the benefits outweigh Review and update every 3 months. List goals. the risks. Counseling is important. Here To Treat patient, consult and co-manage, or refer. Help.COM

Analgesic Adjuvant Agents Non-opioid pain medications • • Acetaminophen Benzodiazepines Muscle relaxants; Central/Spinal-peripheral Aspirin Aspirin/Acetaminophen/ Caffeine Dextroamphetamines, Modafinil/Provigil, NSAID’s Armodafinil/Nuvigil COX II’s Corticosteroids Tricyclic , SSRI’s, SNRI’s NMDA receptor antagonists GABA agonist, alpha 2-adrenergic agonist Topical agents- , Combinations, Compounded combinations.

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Anesthetics/Pain transmission- Counter-irritants: overrides blocking noxious input, prevents full pain • Nerve blocks recognition. Neurolytic blocks • 1. Hot packs/ hyperthermy Trigger point injections 2. Ice/cold Paravertebral injections, Epidural injections 3. Ethyl Chloride spray Prolotherapy/ Sclerotherapy/ Regenerative 4. Vibration injection therapy (RIT). *5. Transcutaneous nerve stimulation (TENS) or Electrical muscle stimulation (EMS).

Osteopathic/Chiropractic Vitamin/Nutraceutical Manipulative Treatment Antiinflammatories • May relieve or reduce pain. • Glucosamine/Chondroitin sulphates May restore or improve range of motion and Boswella function. Omega 3 Fish Oil-EPA/DHA/GLA (Borage seed oil), Use HVLA, Muscle energy, Myofascial release Perilla oil , Krill oil (MFR), Strain- Counterstrain, et al. Cod liver oil, Flaxseed oil, Evening Primrose oil If one type does not help, use another method or Udo’s Choice oil may need to use combinations- muscle energy + Methylsulfonylmethane (MSM) HVLA. Shark cartilage • Use OMT in conjunction with any other treatment Serraflazyme modalities. “Arthropro” Use proper CPT/ICDM codes for reimbursement. “Chondrox” *Turmeric ! Take OMT refresher courses! Osteo-Bi Flex: Gluc.+Chondr.+MSM. Triple Strength

Opioids Commonly Prescribed for Management of Common Opioid Moderate-to-Severe Pain Side Effects Step 2 opioids (combination*) • • Codeine Not recommended for use – prophylactic use of laxatives and stool softeners • • Meperidine • Nausea and vomiting • Hydrocodone • Buprenorphine -Patch? – neuroleptics, metaclopramide, cisapride, antivertigenous • Oxycodone • Pentazocine? drugs • • Sedation Step 3 opioids (single agent) • – discontinue other CNS depressants • Morphine • – add psychostimulants • Fentanyl • Respiratory depression • Oxycodone – monitor if not severe; carefully administer naloxone if • Hydromorphone severe Oxymorphone

* Usually combined with aspirin or acetaminophen.

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Management of Common Opioid Side Effects Dose Titration and Timing • Orient patient to report side effects • Start low to minimize side effects, enhance • Routinely assess side effects compliance • Dose to analgesic effect • Manage with specific agents/antinauseants • No ceiling effect to analgesia with opioids -watch for • Manage by switching opioid agent or changing pulmonary central depression dosing regimen • No maximum dose of opioids • Titrate both ATC and breakthrough medications • Analgesic effects must be balanced with side effects

Characteristics of Breakthrough Pain Treating Pain–Ideal • Moderate to severe intensity Over Medication • Rapid onset (< 3 minutes in 43% of patients) Ideal Breakthrough • Around-the-Clock Medication Relatively short duration Medication • Frequency: 1- 4 episodes per day

Ideal Breakthrough Pain Medication • Rapid onset • Short duration of effect Post Herpetic • Minimal side effects • Noninvasive, easy to use • Cost-effective

Z-13 American Osteopathic College of Occupational and Preventive Medicine 2015 Mid Year Educational Conference, Ft. Lauderdale, Florida

DPN and PHN Fibromyalgia

• Pregabalin (Lyrica). • New choices and options: Pregabalin/Lyrica. Add Milnacipran (Savella) antiviral. . (Cymbalta) Lidocaine patches and NMDA- receptor antagonists Central sensitization, painful fascia, nonrestorative Severity often requires opioids for breakthrough sleep, improving evidence based medicine: fibrous pain. . tissue inflammatory and CNS and glutamate findings. • Functional MRI and PET scan findings different from normal patients are definitive.

Pharmacotherapy for Arthritis Primary Dysmenorrhea

OA RA • Cramping, lower abdominal pain at the onset of • • DMARDs menstruation; no underlying pathology • NSAIDs • NSAIDs • Most common gynecologic problem in menstruating – nonselective – nonselective women – COX-2 selective inhibitors – COX-2 selective inhibitors – experiencedby up to 90% of women • Intra-articular glucocorticoids • Local or low-dose systemic – a reason for missed workdays • Intra-articular hyaluronic acid steroids • Treatment includes oral/IM contraceptives and anti- •Opioids for severe. • Opioids for severe. inflammatory agents

ACR Subcommittee on OA Guidelines. Arthritis Rheum. 2000;43:1905-1915. Coco AS. Am Fam Physician. 1999;60:489-496. ACR Subcommittee on RA Guidelines. Arthritis Rheum. 2002;46:328-346. Jamieson DJ, Steege JF. Obstet Gynecol. 1996;87:55-58.

Why Use Cox II Inhibitors? When can you utilize Cox-II’s?

• 1. Approx. 200 deaths attributed to Oxycontin use/abuse in 2002. • 1. Any acute or chronic pain syndromes if not 2.Approx. 16,000 deaths in 2002 related to contraindicated. NSAID side affects. a. somatic pain 3. It makes common sense to more safely b. visceral pain (dysmenorrhea) utilize Cox II’s vs. traditional NSAIDs. c. neuropathic pain-as adjunctive treatment 2.OA-RA-Rheumatoid variants 3. As safe or safer than NSAID’s for longer term usage ?

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What to do if your patient cannot Other New Choices tolerate COX-II meds? • Tylenol/Acetaminophen if no liver disorders • Fosphenytoin (Cerebyx)- inactive pro-drug of phenytoin. Hcl (Nucynta)- dual mode centally acting opioid nor elevated liver enzymes. with Mu agonism and norepinephrine reuptake inhibition. Tramadol-Acetaminophen (Ultracet) if Oxycodone-Naltrexone (Oxytrex)- analgesic equivalent to oxycodone, lower risk for physical dependence. Acetaminophen alone is not effective. Opana-ER- extended release oxymorphone. Tramadol alone in patients with liver disorders Hydromorphone extended release (Exalgo)- extended release for chronic pain patients. or with elevated liver enzymes. Nucynta-ER. Start going up Analgesic ladder if appropriate Buprenorphine patch- moderate pain patients. and medically necessary.

Risk Evaluation and Mitigation Strategy Senate Bill 0462 (REMS). • 1.Establish electronic monitoring system for scheduled II-IV Rx’s. PDMP. It is here now! Sign up! • Goal 1: Inform patients and healthcare 2.Avoid drug duplication and interactions. 3. Enhance capacity for law enforcement agencies to professionals about potential for abuse, collect and analyze data in order to reduce drug misuse, overdose, and addiction to opioids. diversion. 4. Regulate “Pain Clinics”. Goal 2: Inform patients and healthcare If over 50% of patients you see are prescribed opioids professionals about safe use of opioids. for chronic pain, you must register with the AHCA. Department of Health received federal grant for Opana-ER, Suboxone, Exalgo, Nucynta-ER, and prescription drug program for $400,000. Oxycontin manufacturers are Prescription Drug Monitoring Program/PDMP is up encouraging/promoting REMS. and running! • www.E-FORCSE.com- It works! It can save your • 2 hour course offered by FOMA/AOA. license and protect your practice.

Senate Bill 2272 Pain Clinic Law House Bill 7095/456.44, F.S. You must be registered with AHCA by October 1, 2010 if you advertise • As of July 1, 2011, Physicians will no longer be pain managementservices or if you prescribe opioids to more than 50% of your patients. authorized to “dispense” controlled substances. Additional exemptions to pain management clinic registration. Limitations on ownership of a pain management clinic as of July 1,2012. Exceptions 1.Complimentary or sample controlled Only MD/DO may dispense any medication at a pain management clinic; substances. 2.Dept. of Corrections. 3. Post –Op the MD/DO must perform a physical on same day that he/she subscribes or dispenses controlled substance to patient at pain management clinic; limits. 4. Clinical trials, approved. 5. Methadone prohibits dispensing more than 72 hr. supply of controlled substances to a patient at a pain management clinic for cash, check, or credit card.; licensed treatment programs. 6. Hospice. requires use of counterfeit-resistant prescription blanks at pain Effective 1-1-2012 Each Physician who prescribes management clinics. Prohibits promoting, advertising by any physician in any controlled substances for the treatment of chronic communications media the use, sale, or dispensing of any controlled substances. nonmalignant pain must designate with their Requirements/limitations on designated physicians, including requiring appropriate Florida State Board on his or her unencumbered license. Limitations on who may practice in a pain management clinic after July practitioner profile that he or she is a controlled 1, 2012. Criminal and disciplinary penalties for violations. substance prescribing practitioner. Standards-same Do you use “pain” in any of your advertising? as state and federal. Some physicians are exempt.

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HB- 7095/ 456.44/ F.S. HB- 7095/ 456.44/ F.S. • Development of a written individualized treatment • The standards of practice for a controlled substance plan for each patient, with objectives for treatment prescribing practitioner are spelled out in the law. success and other treatment modalities. • A complete medical history and physical exam. • Discussion with patient concerning risks and benefits of use of controlled substances. • A written agreement between physician and patient that includes reasons for which drug therapy may be discontinued and that controlled substances shall be prescribed by a single treating physician, unless authorized and documented in the medical record./

HB- 7095/456.44, F.S. Legislation 64B15-14.005 • Regular follow up appointments at least every 3 • months to assess efficacy and appropriateness of Effective Jan. 1 2012. Complete Hx and Px treatment- low risk, moderate and high more often. before any treatment. Some specialists exempt. • Referrals to specialists when indicated. • Individual treatment plan for each patient. • Maintenance of accurate and complete medical • records for each patient – I recommend EHR/EMR. Risks , benefits of controlled substances as well as abuse, addiction, physical dependence. • Certain Certified specialists and surgeons are • exempted from these standards of practice. Written controlled substance agreement. • • Counterfeit-proof prescription pads/ blanks must be Patient will be seen at regular intervals not to used by practitioners for prescribing of any exceed 3 months. controlled substance as of July 1. 2011. They must • Maintain accurate, current, and complete be Board approved. Numeric and word numbers records.

Legislation 64B15-14.005- continued Board/AHCA-Guidelines • Medical records must include but are not limited to: A) Evaluation-complete H&P, document nature/intensity of pain, current and past Txs, coexisting conditions, & presence of 1 or Complete Hx and Px including Hx of drug abuse or more recognized medical conditions for use of controlled dependence/Use PADT-ORT. Diagnostic, lab, substances or off-label medication uses. therapeutic results. Evaluations and consultations. B) Treatment plan-objectives, individualize, document response, Treatment objectives. Discussion of risks and amend plan each visit. benefits. Treatments. Rxs-Medications including C) Informed Consent/Patient Agreement-Patient and Doctor date, type, dose, and quantity prescribed. obligations and duties, unannounced urine tests, compliance to Instructions and agreements. Periodic reviews, at plan, including proper medication schedule, pill counts. least every 3 months. Results of drug testing. Photo D) Periodic Review-modify plan each visit, document changes in pain levels, levels of functioning, compliance to treatment plan. of patient’s government issued photo identification. 3 Month Review of plan standard. If a written controlled substance is given to patient, E) Consultations-Orthopedics, Neurology, Psychiatry, Physical a duplicate/copy of the prescription. The physician’s Medicine, Neurosurgery, Rheumatology: Co-manage vs. 2nd full name presented in a legible manner. Opinion vs. Refer- Low risk, medium risk, high risk.

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Board continued. • F) Medical Records- document everything! Dictate or utilize electronic medical records for most accurate and defendable documentation. Include all discussed in A through E. Records must be current, maintained in accessible manner and readily available for review. G) Compliance with Controlled Substances Laws and Regulations, State Board and AHCA Guidelines- Remain current, keep up with CME, AOA, AMA, FOMA, FMA, Academy resources. Use E-FORCSE.com.

Questions? Thank you!

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