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Understanding State Board Regulations: Providing Compassionate Care While Avoiding Common Mistakes Joe Y. Kim, MD Water’s Edge: Memorial’s Pain Relief Institute Washington State • Follows Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain • Federation of State Medical Boards • July 2013 (1997, 2003) Washington State • Since 2004 • 1 in 4 in primary care settings, pain limits ADL’s • Undertreatment of pain is serious public health problem Inappropriate Management • Inadequate initial assessment for clinical indication • Inadequate monitoring • Inadequate attention to patient education/consent • Unjustified dose escalation: risks? alternatives? Discipline • “Physicians should not fear disciplinary action from the Board for ordering, prescribing, dispensing or administering controlled substances, including opioid analgesics, for a legitimate medical purpose and in the course of professional practice, when current best clinical practices are met.” Discipline • “The Board will not take discplinary action against a physician for deviating from this Model Policy when contemporaneous medical records show reasonable cause for such a deviation.” • “The board will judge the validity of the physician’s treatment of a patient on the basis of available documentation, rather than solely on the quantity and duration of medication administered”. Guidelines • Understanding Pain: • Patient Evaluation and Risk Stratification • Development of a Treatment Plan/Goals • Informed Consent/Treatment Agreement Guidelines • Initiating an Opioid Trial • Ongoing Monitoring and Adapting the Treatment Plan • Periodic Drug Testing • Consultation and Referral Guidelines • Discontinuing Opioid Therapy • Medical Records • Compliance with Controlled Substance Laws and Regulations Methadone • Increased rate of methadone related deaths • QTc: pre, 3days, annual • 450-500 ms discuss (debate) • “No evidence has been found to support the use of the EKG for preventing cardiac arrhythmias in methadone-treated opioid dependents” Cochrane investigators Methadone • Follow up sooner after: • • Initiation or increase Pharmacodynamics/kinetics • Analgesic action 6 hrs (morphine is opposite) • Full analgesic effects • • Morphine conversion median 5 days (range 4-13) • May be 1-2 weeks Long half-lfe/accumulation ==> delayed toxicity Methadone • Equianalgesic for repetitive dosing smaller than single-dose • 65 y/o decreased clearance • No liver adjustments • Metabolites do not accumulate with renal failure Methadone • Increased rate of methadone related deaths What is the ideal opioid? • half-life, side effects, metabolites, etc… What is the ideal opioid? Oxycodone No ceiling dose Minimal side effects Absence/minimal activce metabolite Easy titration Rapid onset Short half-life Long duration Predictable pharmacokinetics Random Considerations • T3/T4: ceiling effect 60mg/dose, max 360mg/day • Hyrdocodone: maximal daily 60mg/day? • Morphine: renal failure (M6G); rectal? • Oxymorphone: hepatic impairment Random Considerations • Tapentadol (Nucynta): seizures, ICP, asthma • inhibit serotonin/NE reuptake • Tramadol: 5HT, cardiovascular, seizures, addiction • TCA/MSO4: synergistic CNS/respiratory depression Guidelines • Patient Evaluation and Risk Stratification • • Indication/Evaluation Assessment • Nature, intensity, treatments, comorbidities, function. • ROS, SH, FH (abuse), PE, labs?, SOAPP-R, ORT • All patients should be screened for depression/mental health Guidelines • Assessment • History of substance abuse: failure/harm • • If possible, consult before therapy initiated. Current abuse • Established in treatment/recovery program • Co-managed with addictions specialist Terms • Tolerance • Dependence • Abuse • Addiction Guidelines • Assessment • Brings in own pile of records • • ask for records directly PMP Guidelines • Development of a treatment plan/goals • • • Goals • Improvement of pain and function • Improvement of pain associated symptoms Avoidance of unnecessary/excessive use of meds Revisited regularly Guidelines • Development of a treatment plan/goals • Individualized • Supports selection of treatment • Objectives to evaluate progress • pain relief • physical/psychosocial function Guidelines • • Informed consent • Risks/benefits • Why change Treatment agreement • Goals • Patient’s/physician’s responsibilities Guidelines • Informed consent/Treatment agreement • Shared decision • Store/disposal Guidelines • Initiating an Opioid Trial • Present as a trial (e.g. 90 days) • Evaluate benefit (pain/fxn/QOL) vs. harm • Lowest possible start dose • Short acting Guidelines • Ongoing Monitoring and Adapting the Treatment Plan • Collateral information: family, close contacts, PMP • More frequently at first • Five A’s: Analgesia, Activity, Adverse Effects, Aberrancy, Affect/mood Guidelines • Ongoing Monitoring and Adapting the Treatment Plan • Continue? • Progress towards goals (pain, fxn, QOL) • Absence of risks/adverse events More meds • Psychotherapy • Rehabilitative • Injection • Surgery • Medications More meds • Anti-inflammatory • Antidepressants • Membrane stabilizers • Muscle relaxants • Opioids Escalations • Can be a sign of use disorder/diversion • • Good time to get UDS “halftime” rule High doses • 200mg (MED) in 2010, lower now • Concerns • Hyperalgesia • Neuroendocrine • Immunosuppression Guidelines • Periodic Drug Testing/Screening • Clinical judgement > recommendations • Discuss in supportive fashion • Pill count “useful” • PMP “highly recommended” Opioid Rotation • Intolerable side effects • Inadequate benefit • 25-50% reduction Rotation • Total 24-hour dose • Calculate new dose • 50-65% got incomplete cross-tolerance • Consider rescue Rotation • Fentanyl 50% decrease in 17 hours • Calculate new dose • 50-65% got incomplete cross-tolerance • Consider rescue Guidelines Periodic Drug Testing/Screening • • Unsatisfactory progress • Intervention needed: • early refill • multiple lost/stolen rx • physician shopping • intoxication/impairment • pressuring/threatening behavior • illicit/unprescribed drugs Guidelines • Periodic Drug Testing/Screening • Intervention needed: • Behavior suggesting RECURRING misuse • self-increase dose • deteriorating function • failure to comply to the treatment plan Guidelines • Periodic Drug Testing • “Firm response” • Forgery • Obvious impairment • abusive/assaultive behavior Transit times (inexact) Rapid: • • EtOH 7-12 hrs • Pentobarbitol (24h) • Propoxyphene 6-48 hrs Transit times Fast: • • (Meth) Amphetamine 48 hrs • Codeine 48 hrs • Heroine 48 hrs • Cocaine metabolites 2-4 days • Hydromorphone 2-4 days • Methadone 3 days • Short-acting BZ’s 3days • Long-term/heavy 30 d Transit times Long • • PCP 8 days • Phenobarbital 3 wks • Long-acting BZ’s 30 days Guidelines • Consultation and Referral • • Pain, psychiatry, addiction, or mental health specialist “if needed” • History of substance abuse • Co-occuring mental health disorder Know treatment options in treatment programs for addictions Guidelines Discontinuing Opioid Therapy • • Regularly weigh benefits/risks • Discontinue • resolution • intolerable side effects • inadequate analgesia • failure to improve QOL • significant aberrancy Guidelines • Discontinuing Opioid Therapy • Structured tapering regimen • Withdrawal • • Addiction specialist or physician Not the end (direct care or referral) Weaning off • Repeated aberrant drug-related behaviors • Diversion • Intolerable side effects • No progress towards goals “More Serious” • Repeatedly non adherent • Cocaine • Unprescribed opioids • Doctor Shopping • Unprescribed opioids • Morphine example “Non-serious” • 1-2 unauthorized dose escalations • Alcohol Wean off • Rehabilitation setting ideal • Addiction • Addiction treatment made available • Follow-up • Non-opioid pain management Wean off • Slow: 10%/ week • Rapid: 25-50% every few days • At higher doses, can be more rapid • When get to lower doses, slow down Guidelines • Medical Records • Copies of the signed informed consent and treatment agreement • Patient’s medical history • Results of physical exam and laboratory tests • Results of risk assessment (e.g. screen tools) • Description of treatments provided • Instructions to the patient (e.g. risks, benefits) Guidelines • Medical Records • Results of ongoing monitoring of patient progress (pain/fxn) • Notes on evaluation/consultations of specialists • Any other supporting information to support • Authorization of release of information Universal Precautions • 1. Make a diagnosis with an appropriate differential • 2. Conduct a patient assessment, including risk for substance use disorders • 3. Discuss the proposed treatment plan with the patient and obtain informed consent • 4. Have a written agreement that sets forth the expectations and obligations of both the patient and treating physician • 5. Initiate an appropriate trial of opioid therapy, with or without adjunctive medications Universal Precautions • 6. Perform regular assessments of pain and function. • 7. Reassess the patient’s pain score and level of function • 8. Regularly evaluate the patient in terms of the “5 A’s” • 9. Periodically review the pain diagnosis and any comorbid conditions (including substance use disorders) and adjust the treatement regimen accordingly • 10. Keep careful and complete recored of the initial evaluation and each follow up visit. State Website • Can I drink alcohol while taking pain medication? • • “Talk to your healthcare provider. Alcohol may have unintended consequences…” If a patient has been at 140 mg MED for several years, do I need to consult a pain specialist? • “No, For a patient with stable pain and function, on a non-escalating dosage of opioids, the consultation requirement would not be required as long as the practitioner documents these items.” Scoping the Addict • Most strongly predictive factor: • personal/family history of alcohol/drug abuse. • Younger • Psychiatric history Scoping the Addict • Travel • Escalation of dose • Focus on one medication • Affect • End of week refill The “High Risk Patient” • History of drug abuse • Psychiatric issues • Serious aberrant drug-related behaviors The “High Risk Patient” • Benefits outweigh risks • “Strongly Consider” • Mental health specialist • Addiction specialist The “High Risk Patient” • Referral/change/discontinue • Precise prescription • 4 strikes and you’re out: How often to visit with? • Stable, Low risk: 3-6 months • High risk: up to weekly • addictive disorder • job requiring mental acuity • elderly • social/psychiatric/medical The “High Risk Patient” • Change • More frequent/intense • Tapering (permanent/temporary) • Psychological therapies • Nonopioid treatment The “High Risk Patient” • Discontinue • Diversion, forgery, stealing/buying • Serious aberrant behavior • • Injecting oral meds Dangerous/suicidal behavior Driving • • Effects (Especially at first, with increases, or mixed) • Somnolence • Clouded mentation • Decreased Concentration • Slower reflexes/incoordination Studies don’t show increase accidents Driving • A person is guilty of driving while under the influence of intoxicating liquor or any drug if the person drives a vehicle within this state: While the person is under the influence of or affected by intoxicating liquor or any drug; or While the person is under the combined influence of or affected by intoxicating liquor and any drug. Driving • A person is guilty of negligent driving in the first degree if he or she operates a motor vehicle in a manner that is both negligent and endangers or is likely to endanger any person or property, and exhibits the effects of having consumed liquor or an illegal drug. • However, legal entitlement to use the drug is a defense to the charge of “negligent driving” [§46.61.5249 (1)(a)] if the defendant had a valid prescription for the drug consumed and had been consuming the drug according to the prescription directions and warnings.