Carondelet Medical Group Presents Issues Facing Primary Care Today
Pain Management Preventing Provider Burnout Urology as seen in PCP Offices Disclosures for Today’s Presenters:
The following speakers attest they have no relevant financial relationships with any commercial interests to disclose:
Christine Donnelly, MD Carondelet Medical Group Erin Hager, DEA Estelle Farrell, DO, Pima Pain Center Stephen Shiller, MD Pima Pain Center Jerry Greenberg, MD Carondelet Medical Group, Urology Pamela Laubscher, DO Carondelet Medical Group
The following speakers have disclosed the following relevant financial relationships with commercial interests:
Jerome Grove, MD, Pima Pain Center–Speaker fees from Depomed, Pfizer, Astra Zeneca Emil Annabi, MD, Pima Pain Center -Speaker fees from Depomed, Collegium, Purdue
Demystifying the DEA
Erin Hager – DEA Diversion Investigator The Diversion Control Division’s mission is to prevent, detect and investigate the diversion of pharmaceutical controlled substances and listed chemicals from legitimate channels while ensuring an adequate and uninterrupted supply of pharmaceutical controlled substances and listed chemicals to meet legitimate medical, commercial and scientific needs. Regulatory Diversion Tactical Diversion Primary function: To prevent and Primary function: To investigate detect controlled substance/listed controlled substance/listed chemical diversion. chemical diversion
•Scheduled compliance •Conduct criminal drug investigations investigations -Recordkeeping and security -DEA registrants/non- registrants •Processing applications for DEA registrations •Administrative/Civil/Criminal -Pre-registration investigations sanctions
•Administrative/Civil sanctions •Forfeiture potential
≠ 21 U.S.C. 841(a)(1) “Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally to manufacture, distribute, or dispense a controlled substance.”
Penalty 21 U.S.C. 841(b): (Dependent on quantities)
A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. 21 C.F.R. § 1306.04(a). • Includes the 6 fundamentals of a doctor examination
Medical history (personal and family) Physical Exam Appropriate tests conducted on patient to arrive at a diagnosis The diagnosis of the problem Course of Treatment Follow-up
• A circumstance that does or should raise a reasonable suspicion as to the validity of a prescription. • “Red Flags” typically have been interpreted to be more likely to reflect drug abuse, addiction, or diversion (i.e., criminal activity).
• Various courts have determined that these red flags provide knowledge to pharmacists which cannot be deliberately ignored without violating the law. • Drugs known for diversion/abuse
• High quantities or dose prescribed
• Patients seeking early refills
• Patients traveling long distances to doctor or pharmacy • “Doctor shopping” or “pharmacy shopping”
• A high ratio of controlled to non-controlled substances
• A high percentage of cash payments for controlled substances (CS)
• “Cocktail” prescribing (opioid, benzo, muscle relaxant)
• Customers appear to be drug addicts, or their behavior/appearance does not match their purported medical condition.
• Clear lack of individualized dosing of medication by certain doctors.
• Patient admits to taking prescribed medication for invalid purpose.
1. Defendant distributed or dispensed a controlled substance; 2 . Did so knowingly or intentionally; and 3. Defendant’s actions were not for “a legitimate medical purpose within the usual course of professional practice.” • Under U.S.C. 841(a)(1): Doctor or practitioner distributes a controlled substance knowingly and intentionally outside the usual course of professional practice for and other than in good faith (legitimate medical purpose, valid doctor-patient relationship). NOTE: Each bad prescription is a separate crime of distribution under 841(a)(1) 21 U.S.C. 842(a)(1)
“It shall be unlawful for any person who is subject to the requirements of part C to distribute or dispense a controlled substance in violation of section 829 of this title.”
Penalty 21 U.S.C. 842 (c)(1)(A): “… any person who violates this section shall, with respect to any such violation, be subject to a civil penalty of not more than $25,000.”
CPT NUMBER OF CPT AVERAGE MINUTES TOTAL AVERAGE MINUTES CONVERSION OF MINUTES TO CODE PATIENTS HOURS
99213 1 15 minutes 15 minutes .25 hour
99214 153 25 minutes 3825 minutes 63.75 hours
99215 1 40 minutes 40 minutes .67 hour
99244 2 60 minutes 120 minutes 2 hours
99245 2 80 minutes 160 minutes 2.66 hours
TOTAL 159 patients 4160 minutes 69.33 hours
24
Integrative Pain Management Estelle Farrell, DO, FAOCPMR Osteopathic Physical Medicine and Rehabilitation Past President AOCPMR
“Help” by Jason Nierenberg Integrative Pain Management
Pain is an unpleasant sensation whether threatened or real in response to a stimulus.
Injury/damage
Disease/metabolism
Fear/loss of control/Psychological
Integrative Pain Management How To Look For The Cause?
Look, Listen, Touch, Feel, Test
Keep it Simple
Then Look Deeper Integrative Pain Management How To Look For The Cause? Where
What
When
Why sometimes gets left behind
Who depends on perspective
Integrative Pain Management How To Look For The Cause? Why
Understanding the cause allows for proper
treatment no matter the approach Integrative Pain Management How To Look For The Cause?
Who
Who and what has already been done to help, hurt, or not make much of a change?
Who is there to support you in your path Integrative Pain Management How To Look For The Cause? Where Integrative Pain Management How To Look For The Cause? What Happened
What didn’t happen
What worked… or not Integrative Pain Management How To Look For The Cause?
When
Did it start?
How long is it lasting?
Timing…..is a lot, but not everything Integrative Pain Management How To Look For The Cause? Traditional and Conservative
History
Examination
Imaging
Basic labs
Referral to a Specialist
Integrative Pain Management How To Look For The Cause? Integrative Approach working within and outside the box
Start with the Traditional
Biomechanical analysis
Deeper lab Analysis
Social interaction/support/Psychological input
Philosophical interpretation Integrative Pain Management How Is Pain Treated? Physical
Chemical/Medicinal
Metabolic/Nutrition
Psychological
Spiritual Integrative Pain Management How Is Pain Treated
Traditional and Conservative
Direct Treatment
Surgical
Therapy ...although there are many types…
Medication Integrative Pain Management How Is Pain Treated Integrative: takes into account the Traditional and Conservative Approach
Functional Approach
TCM: 5 elements and Ba Gua
Medicinal approaches: homeopathic, naturopathic, other influences
Biomechanical
Systemic/nutritional/neurotransmitters
Spiritual/Psychological Integrative Pain Management How Is Pain Treated Not Every Herb is Marijuana What about Kratom?
Integrative Pain Management How Is Pain Treated Pain Medication Ladder
FDA recommendations
CDC recommendations
DEA recommendations
State guidelines
Professional guidelines
Lowest dose of Opiates for the least amount of time Integrative Pain Management How Is Pain Treated Medications Used In Pain Control: Typical other than Opiates
Anti-inflammatories
Tylenol-based
Anti-epileptics
Anti-depressants
Muscle relaxers ( a few classes of these) Integrative Pain Management How Is Pain Treated Atypical Medications Used in Pain Management
Low Dose Naltrexone
Blood Pressure Medications
Weight loss Medications
Topical preparations Integrative Pain Management How Is Pain Treated Medical Alternative Therapies for Pain
Cold laser
Acupuncture
Electrical: TENS, High Frequency, Scrambler, Frequency Specific; Wave specific
Injection
Manipulation
Integrative Pain Management How Are People in Pain Living Counselling and Mind Body techniques Tapping
EMDR
Hypnosis
Meditation
Yoga Integrative Pain Management How Are People in Pain Living Perspective adjustments
Epigenetics
Modified living
Integrative Pain Management How Are People in Pain Living
Giving …. and Receiving
Volunteer work receiving donations
Crafts and Hobbies accepting help and food
Internet blogs Sharing experiences and advice
Medication Management And CDC GUIDELINES Overview MM For Pain
Atypical Opioids
Buprenorphine Tapentadol MM For Pain
Opioids
Short Acting Long Acting MM For Pain
SMR
Benzodiazepines Anti-Spasmodic Anti-Spasticity Agents Agents MM For Pain
Neuropathic Medications
TCA SSRI Antiepleptic SNRI MM For Pain
NSAIDS
Traditional COX-2 Selective Medication Management for Pain
Atypical Traditional NSAIDS Opioids Opioids
Skeletal Muscle Relaxers
Neuropathic Medications Documentation
Accurate and Complete Records Should Include:
1. Medical history and Physical Exam 2. Diagnostic, Therapeutic, and Laboratory Results 3. Evaluations and Consultations 4. Treatment Objectives 5. Discuss of Risks and Benefits 6. Informed Consent 7. Treatments 8. Medications (Including date, type, dosage and quantity prescribed) 9. Instructions and Agreements 10.Periodic Reviews Considerations When Using Opioids
• Opioids are effective treatment options for chronic pain, but have the potential for abuse • Physicians, Patients, and the Healthcare system have responsibilities regarding the legal and ethical use of opioids • Effective risk assessment and clinical management, including screening measures and monitoring strategies, can protect your patient and your practice from the aberrant drug-taking behaviors and there outcomes. • Prescribing, Dispensing, and Receiving a CS is a "privilege, and not a right" CONSIDERING YOUR OWN CHRONIC PAIN PATIENT POPULATION
What complexities of Pain Management come to mind when evaluating a patient for Opioid therapy? Opioid-Naïve or Switch Therapy?
• Current type, potency, and • Type of Pain dose of medication • Pain-related functional • Patient opioid experience impairment and opioid tolerance • Comorbid conditions, • Withdrawal symptoms multiple medications, and drug-drug interactions. • Adverse reactions
• Substance abuse history/ risk or abuse Pharmacological Management is Challenging:
• Acetaminophen • Topical Agents • Skeletal Muscle Relaxants • Anticonvulsants • Antidepressants • Alpha, Adrenergic Receptor Agonists • NMDA Receptor Antagonists • NSAIDS • Opioids Best Practices for Opioid Prescribing
• Use an Opioid Treatment Agreement • Educate patients (care givers, family members) on Opioid Safety • REMS for long-Acting and extended-release opioids • Patient document from prescriber • Medication guide from pharmacist • Initiate an Opioid Trial • Structure therapy and Monitor commensurate with risk • Predefine attainable treatment goals for pain relief and function • >30% reductions in Pain scores may be clinically relevant • Titrate too acceptable balance between analgesia and tolerable side effects • Administer baseline and periodic drug testing • Follow Up and assess outcomes and adherence CDC Guideline for Prescribing Opioids for Chronic Pain 2016 Intent of the CDC Guideline
• The CDC Guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end of life care • The Guideline is intended to improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain, improve safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy. • The CDC is a set of 12 recommendations and is grouped into 3 areas for consideration Determining when to initiate or continue opioids for chronic pain Opioid selection, dosage, duration, follow-up, and discontinuation Assessing risk and addressing harms of opioid use The CDC Guideline is a set of 12 Recommendations Grouped into 3 Areas
Area 2: Opioid Selection, Dosage, Duration, Follow- Up, and Discontinuation • When starting opioid therapy for chronic pain, clinicians should prescribe immediate- release opioids instead of extended-release/ long-acting (ER/LA) opioids. • When opioids are started, clinicians should prescribe the lowest effective dose. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risk when increasing dosage to >90 MME/ day or carefully justify a decision to titrate dosage to >90 MME/ day. • Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate- release opioids and should prescribe no greater quantity then needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more then seven days will rarely be needed. • Clinicians should evaluate benefits and harms with patients 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids. The CDC Guideline is a set of 12 recommendations Grouped into 3 Areas Area 3: Assessing Risk and Addressing Harms of Opioid Use • Before starting and periodically during continuation of opioid therapy, clinicians should evaluate harms of opioid use. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for Opioid overdose, history of substance use disorder, higher Opioid dosages (>50 MME/ day), or concurrent use, are present. • Clinicians should review the patients history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during Opioid therapy for chronic pain, ranging from every prescription to every 3 months. • When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as Wells's other controlled prescription drugs and illicit drugs. • Clinicians should avoid prescribing Opioid pain medication and benzodiazepines concurrently whenever possible. • Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) or patients with opioid use disorder. The CDC Guideline is a set of 12 Recommendations Grouped into 3 Areas
Area 2: Option Selection, Dosage, Duration, Follow-Up, and Discontinuation
• When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to >50 Morphine milligram equivalents (MME)/ day, and should avoid increasing dosage to >90 MME/ day or carefully justify a decision to titrate dosage to >90 MME/ day. The CDC Guideline: MME Doses for Commonly Prescribe Opioids Equianalgesic dose conversions are only estimates and cannot account for individual variability in genetics and pharmacokinetics
Opioid Conversion Factor Codeine 0.15 Fentanyl transdermal (in mcg/hr) 2.4 Hydrocodone 1 Hydromorphone 4 Methadone 1-20 mg/ day 4 21-40 mg/ day 8 41-60 mg/ day 10 >60-80 mg/ day 12 Morphine 1 Oxycodone 1.5 Oxymorphone 3 Tapentadol 0.4 What are Morphine Milligram Equivalents (MME)?
Definition and Purpose of MME
• MME, also called morphine equivalent dosing (MED) or oral morphine equivalent (OME), provides doses of analgesics with different potencies and mechanisms of action (MOA) . Equianalgesic doses of different opioids provide comparable analgesic efficacy . Because MME is based on equianalgesia, can be applied to non-opioids . Morphine milligram equivalents (MME)/ day: The amount of morphine an Opioid dose is equal to when prescribed, often used as a gauge of the abuse and override potential of the amount of opioid that is being given at a particular time. The End The Utilization of Opiate Medications for Chronic Pain: Protecting the Patient and the Provider. Presented by: Stephen Allen Shiller, M.D.
Pima Pain Center:
The practitioners at Pima Pain Center would like to take this opportunity to thank the many referring providers in this room for allowing us the privilege to assist you in the management of the patients under your care. Although we try not to take ourselves too seriously, we do not take this responsibility lightly, and we greatly appreciate the trust you have placed in us. Thank you.
Background:
• The understanding, identification and management of pain remains an increasing challenge for health care providers. Pain related symptoms, predominantly of musculoskeletal etiology, have been estimated at a rate of 43% among adults in the United States (4).
• Pain can be classified as being either acute (associated with traumatic injury and surgery) or chronic (associated with terminal conditions including vascular disease or cancer versus non-terminal conditions including arthritis, neuropathy or an unknown etiology (3,4,6).
• Chronic pain is classically defined as pain lasting >3 months or as persisting past the time of normal tissue healing (5). Background:
• Following the recognition of pain as the fifth vital sign, there has been an increase in the public focus as well as oversight and scrutiny over the methodology of pain management. The focus of this increased attention is related to the utilization of opioid medications in pain management.
• Recent estimates report that 20 to 25% of patients presenting to physician offices with noncancer pain symptoms or pain-related diagnoses receive an opioid prescription (1,2).
• Complicating the challenge of chronic pain management, adverse outcomes associated with the misuse, abuse and diversion of prescription opioids have increased dramatically (7). Physicians and other health care professionals have contributed—often inadvertently—to these increases. Background:
• One recent study found that in the United States from 1999 to 2014, more than 165,000 individuals died from opioid pain medication overdose (8).
• The increase in adverse effects related to opioid medications continue to inflict a heavy toll on the health care system as well. An evaluation by the Drug Abuse Warning Network of the year 2011, the most recent year data was available, estimated that >420,000 emergency department visits were related to the misuse or abuse of narcotic pain medications (9).
• Addressing this challenge of heavy reliance on opioid medications for chronic pain management, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the Arizona Medical Board have produced guidelines in an effort to provide guidance for primary care providers in the utilization of these medication. Definitions of Relevant Terminology:
• Aberrant Substance Use Behaviors: Behaviors that are outside the boundaries of the agreed-upon treatment plan may constitute aberrant substance use behaviors (10,11). For example, obtaining prescriptions for the same or similar drugs from more than one physician or other health care provider without the treating physician's knowledge is aberrant behavior, as is use of illicit drugs.
• Abuse: Abuse has been described as a maladaptive pattern of drug use that results in harm or places the individual at risk of harm (12). Abuse of a prescription medication involves its use in a manner that deviates from approved medical, legal, and social standards, generally to achieve a euphoric state ("high") or to sustain opioid dependence that is opioid addiction.
• Addiction: A longstanding definition of addiction is that it is "a primary, chronic, neurobiological disease, whose development and manifestations are influenced by genetic, psychosocial, and environmental factors" (13). Addiction often is said to be characterized by behaviors that include impaired control over drug use, craving, compulsive use, and continued use despite harm (13).
Definitions of Relevant Terminology:
• Dependence: Physical dependence is a state of biologic adaptation that is evidenced by a classspecific withdrawal syndrome when the drug is abruptly discontinued or the dose rapidly reduced, and/or by the administration of an antagonist (13). It is important to distinguish addiction from the type of physical dependence that can and does occur within the context of good medical care, as when a patient on long-term opioid analgesics for pain becomes physically dependent on the analgesic. This distinction is reflected in the two primary diagnostic classification systems used by health care professionals: the International Classification of Mental and Behavioral Disorders, 10th Edition (ICD10) of the World Health Organization [70], and the Diagnostic and Statistical Manual (DSM) of the American Psychiatric Association [71].
• Diversion: Drug diversion is defined as the intentional transfer of a controlled substance from authorized to unauthorized possession or channels of distribution (15,16). The federal Controlled Substances Act (21 U.S.C. §§ 801 et seq.) establishes a closed system of distribution for drugs that are classified as controlled substances. Definitions of Relevant Terminology:
• Misuse: The term misuse (also called nonmedical use) encompasses all uses of a prescription medication other than those that are directed by a physician and used by a patient within the law and the requirements of good medical practice (13).
• Tolerance: Tolerance is a state of physiologic adaptation in which exposure to a drug induces changes that result in diminution of one or more of the drug's effects over time. Tolerance is common in opioid treatment, has been demonstrated following a single dose of opioids, and is not the same as addiction (13).
CDC Guidelines:
• According to a recent report cited by the CDC, there has been an increase in primary care clinicians reporting concerns about opioid medication misuse, finging the management of patients with chronic pain stressful, expressing concern about patient addiction, and reporting insufficient training in prescribing opioids (17).
• In response to these concerns, the CDC produced the following guidelines:
CDC recommendations for prescribing opioids for chronic pain outside of active cancer, palliative, and end-of-life care:
• Determining When to Initiate or Continue Opioids for Chronic Pain
• 1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate.
• 2. Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.
• 3. Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy. CDC recommendations for prescribing opioids for chronic pain outside of active cancer, palliative, and end-of-life care:
• Opioid Selection, Dosage, Duration, Follow-Up, and Discontinuation
• 4. When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids.
• 5. When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day.
• 6. Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.
• 7. Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids. CDC recommendations for prescribing opioids for chronic pain outside of active cancer, palliative, and end-of-life care: • Assessing Risk and Addressing Harms of Opioid Use
• 8. Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (≥50 MME/day), or concurrent benzodiazepine use, are present.
• 9. Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.
• 10. When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.
• 11. Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.
• 12. Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder (18). CDC recommendations for prescribing opioids for chronic pain outside of active cancer, palliative, and end-of-life care:
• The nonpharmacologic therapies mentioned in section 1 above were expanded upon with evidence from several studies showing the benefits on exercise therapy and increased activity in reducing pain and improving function in:
• Chronic low back pain (19),
• Osteoarthritis of the knee (20) and hip (21),
• Fibromyalgia symptoms (22). CDC recommendations for prescribing opioids for chronic pain outside of active cancer, palliative, and end-of-life care:
• The CDC also addressed the utilization of nonopioid pharmacologic therapies as showing efficacy for the management of chronic pain including:
• Acetaminophen and NSAIDs for arthritis and axial low back pain.
• Anticonvulsants including Pregabalin (Lyrica) and gabapentin (Neurontin) for diabetic neuropathy, Carbamazepine for post-herpetic neuralgia and Lyrica for fibromyalgia.
• Tricyclic antidepressants and SNRIs for peripheral neuropathy, post-herpetic neuralgia and Fibromyalgia (Duloxetine). CDC recommendations for prescribing opioids for chronic pain outside of active cancer, palliative, and end-of-life care:
• The CDC Recommendations have placed several groups of patients in higher risk catagories, these include:
• Patients with Sleep-Disordered Breathing, Including Sleep Apnea
• Pregnant Women
• Patients with Renal or Hepatic Insufficiency
• Patients Aged ≥65 Years
• Patients with Mental Health Conditions
• Patients with Substance Use Disorder
• Patients with Prior Nonfatal Overdose Arizona Medical Board - Reference for Physicians on the Use of Opioid Analgesics in the Treatment of Chronic Pain, in the Office Setting:
• The Arizona Medical Board has identified a list of circumstances that contribute to both the inadequate treatment of pain and the inappropriate prescribing of opioids by physicians may include:
• Physician uncertainty or lack of knowledge as to prevailing best clinical practices;
• Inadequate research into the sources of and treatments for pain;
• Sometimes conflicting clinical guidelines for appropriate treatment of pain;
• Physician concerns that prescribing needed amounts of opioid analgesics will result in added scrutiny by regulatory authorities; Arizona Medical Board - Reference for Physicians on the Use of Opioid Analgesics in the Treatment of Chronic Pain, in the Office Setting:
• The Arizona Medical Board has identified a list of circumstances that contribute to both the inadequate treatment of pain and the inappropriate prescribing of opioids by physicians may include (Cont.):
• Physician misunderstanding of causes and manifestations of opioid dependence and addiction;
• Fear on the part of physicians of causing addiction or being deceived by a patient who seeks drugs for purposes of misuse;
• Physicians practicing outside the bounds of professional conduct by prescribing opioid analgesics without a legitimate medical purpose; and
• Inadequate physician education about regulatory policies and processes [23-25,31].
Arizona Medical Board - Reference for Physicians on the Use of Opioid Analgesics in the Treatment of Chronic Pain, in the Office Setting:
• The Arizona State Medical Board recently amended their guidelines regarding what will be considered inappropriate management of pain, particularly chronic pain. These new focus points will be deemed a departure from accepted best clinical practices, and will include but are not limited to the following:
• Inadequate attention to initial assessment to determine if opioids are clinically indicated and to determine risks associated with their use in a particular individual with pain: Not unlike many drugs used in medicine today, there are significant risks associated with opioids and therefore benefits must outweigh the risks.
• Inadequate monitoring during the use of potentially abusable medications: Opioids may be associated with addiction, drug abuse, aberrant behaviors, chemical coping and other dysfunctional behavioral problems, and some patients may benefit from opioid dose reductions or tapering or weaning off the opioid.
• Inadequate attention to patient education and informed consent: The decision to begin opioid therapy for chronic pain should be a shared decision of the physician and patient after a discussion of the risks and a clear understanding that the clinical basis for the use of these medications for chronic pain is limited, that some pain may worsen with opioids, and taking opioids with other substances or certain condition (i.e. sleep apnea, mental illness, pre-existing substance use disorder) may increase risk. Arizona Medical Board - Reference for Physicians on the Use of Opioid Analgesics in the Treatment of Chronic Pain, in the Office Setting:
• The Arizona State Medical Board recently amended their guidelines regarding what will be considered inappropriate management of pain, particularly chronic pain (Cont.):
• Unjustified dose escalation without adequate attention to risks or alternative treatments: Risks associated with opioids increase with escalating doses as well as in the setting of other comorbidities (i.e. mental illness, respiratory disorders, pre-existing substance use disorder and sleep apnea) and with concurrent use with respiratory depressants such as benzodiazepines or alcohol.
• Excessive reliance on opioids, particularly high dose opioids for chronic pain management: Prescribers should be prepared for risk management with opioids in advance of prescribing and should use opioid therapy for chronic non-cancer pain only when safer and reasonably effective options have failed. Maintain opioid dosage as low as possible and continue only if clear and objective outcomes are being met.
• Not making use of available tools for risk mitigations: When available, the state prescription drug monitoring program should be checked in advance of prescribing opioids and should be available for ongoing monitoring.
Arizona Medical Board - Reference for Physicians on the Use of Opioid Analgesics in the Treatment of Chronic Pain, in the Office Setting:
• Responsibility for Appropriate Pain Management: All physicians and other providers should be knowledgeable about assessing patients’ pain and function, and familiar with methods of managing pain (32,33).
• 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.
• The Board will consider the use of opioids for pain management to be for a legitimate medical purpose if it is based on sound clinical judgment and current best clinical practices, is appropriately documented, and is of demonstrable benefit to the patient. Arizona Medical Board - Reference for Physicians on the Use of Opioid Analgesics in the Treatment of Chronic Pain, in the Office Setting:
• The Arizona Medical Board has adopted the following criteria for use in evaluating a physician’s management of a patient with pain, including the physician’s prescribing of opioid analgesics:
• Understanding Pain: The diagnosis and treatment of pain is integral to the practice of medicine (32,34- 37). In order to cautiously prescribe opioids, physicians must understand the relevant pharmacologic and clinical issues in the use of such analgesics, and carefully structure a treatment plan that reflects the particular benefits and risks of opioid use for each individual patient.
• Development of a Treatment Plan and Goals: The goals of pain treatment include reasonably attainable improvement in pain and function; improvement in pain-associated symptoms such as sleep disturbance, depression, and anxiety; and avoidance of unnecessary or excessive use of medications (32,33).
• Patient Evaluation and Risk Stratification: The medical record should document the presence of one or more recognized medical indications for prescribing an opioid analgesic (38) and reflect an appropriately detailed patient evaluation (39). Arizona Medical Board - Reference for Physicians on the Use of Opioid Analgesics in the Treatment of Chronic Pain, in the Office Setting:
• The Arizona Medical Board has adopted the following criteria for use in evaluating a physician’s management of a patient with pain, including the physician’s prescribing of opioid analgesics:
• Informed Consent and Treatment Agreement: The decision to initiate opioid therapy should be a shared decision between the physician and the patient (35,40).
• Initiating an Opioid Trial: Generally, safer alternative treatments should be considered before initiating opioid therapy for chronic, non-malignant pain. Opioid therapy should be presented to the patient as a therapeutic trial or test for a defined period of time (usually no more than 90 days) and with specified evaluation points. (41).
• Ongoing Monitoring and Adapting the Treatment Plan: The physician should regularly review the patient's progress, including any new information about the etiology of the pain or the patient’s overall health and level of function (35,42,43). Arizona Medical Board - Reference for Physicians on the Use of Opioid Analgesics in the Treatment of Chronic Pain, in the Office Setting:
• The Arizona Medical Board has adopted the following criteria for use in evaluating a physician’s management of a patient with pain, including the physician’s prescribing of opioid analgesics:
• Periodic Drug Testing: Periodic drug testing may be useful in monitoring adherence to the treatment plan, as well as in detecting the use of non-prescribed drugs (44,45).
• Consultation and Referral: The treating physician should seek a consultation with, or refer the patient to, a pain, psychiatry, addiction or mental health specialist as needed (38-39).
• Discontinuing Opioid Therapy: Throughout the course of opioid therapy, the physician and patient should regularly weigh the potential benefits and risks of continued treatment and determine whether such treatment remains appropriate (46). References:
• (1) Daubresse M, Chang HY, Yu Y, et al. Ambulatory diagnosis and treatment of nonmalignant pain in the United States, 2000-2010. Med Care 2013;51:870–8.
• (2) Institute of Medicine (IOM) of the National Academy of Sciences (NAS). Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research. Washington, DC: National Academies Press, 2011.
• (3) Noble M, Treadwell JR, Tregear SJ et al. Cochrane Database of Systematic Reviews, Issue 1. Long-term Opioid Management for Chronic Noncancer Pain. New York, NY: The Cochrane Collaborative, John Wiley & Sons, Ltd., 2010. Review.
• (4) Tsang A, Von Korff M, Lee S, et al. Common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with depression-anxiety disorders. J Pain 2008;9:883–91. Corrected in: Demytteneare K. J Pain 2009;10:553.
• (5) International Association for the Study of Pain. Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl 1986;3:S1–226.
• (6) Institute of Medicine. Relieving pain in America: a blueprint for transforming prevention, care, education, and research. Washington, DC: The National Academies Press; 2011
• (7) Office of National Drug Control Policy (ONDCP). Epidemic: Responding to America's Prescription Drug Abuse Crisis. Washington, DC: Executive Office of the President, The White House, 2011.
• (8) CDC. Multiple cause of death data on CDC WONDER. Atlanta, GA: US Department of Health and Human Services, CDC; 2016.
• (9) Substance Abuse and Mental Health Services Administration. The DAWN report: highlights of the 2011 Drug Abuse Warning Network (DAWN) findings on drug-related emergency department visits. Rockville, MD: US Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality; 2013.
• (10) Wesson DR & Smith DE. Prescription drug abuse: Patient, physician, and cultural responsibilities. Western Journal of Medicine. 1990;152(5):613-616.
• (11) Parran TV Jr., Wilford BB & DuPont RL. Prescription drug abuse and addiction, Part II: Patient management. Up-to-Date online medical education website [www.uptodate.com]. Philadelphia, PA: Lippincott, Williams & Wilkins, 2012.
• (12) American Pain Society (APS) and American Academy of Pain Medicine (AAPM). Clinical guideline for the use of chronic opioid therapy in chronic noncancer pain. Journal of Pain 2009 Feb; 10(2):113-130.
• (13) American Academy of Pain Medicine (AAPM), American Pain Society (APS), and American Society of Addiction Medicine (ASAM). Definitions Related to the Use of Opioids in the Treatment of Chronic Pain. Glenview, IL: American Pain Society, 2001.
• (14) American Psychiatric Association (APA). Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). Washington, DC: American Psychiatric Publishing, Inc., 2013.
• (15) Johnson CE, Arfken CL, DiMenza S et al. Diversion and abuse of buprenorphine: Findings from national surveys of treatment patients and physicians. Drug and Alcohol Dependence. 2012 Jan 1;120(1-3):190-195. References:
• (16) Cicero TJ, Kurtz SP, Surratt HL et al. Multiple determinants of specific modes of prescription opioid diversion. Journal of Drug Issues. 2011 Spring;41(2):283-304.
• (17) Jamison RN, Sheehan KA, Scanlan E, Matthews M, Ross EL. Beliefs and attitudes about opioid prescribing and chronic pain management: survey of primary care providers. J Opioid Manag 2014;10:375–82.
• (18) CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016 Recommendations and Reports / March 18, 2016 / 65(1);1–49
• (19) Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev 2005;3:CD000335. PubMed
• (20) Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev 2015;1:CD004376. PubMed
• (21) Fransen M, McConnell S, Hernandez-Molina G, Reichenbach S. Exercise for osteoarthritis of the hip. Cochrane Database Syst Rev 2014;4:CD007912 . CrossRef PubMed
• (22) Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev 2007;4:CD003786. PubMed
• (23) Institute of Medicine (IOM) of the National Academy of Sciences (NAS). Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research. Washington, DC: National Academies Press, 2011.
• (24) American Academy of Pain Medicine (AAPM), American Pain Society (APS), and American Society of Addiction Medicine (ASAM). Public Policy Statement on the Rights and Responsibilities of Healthcare Professionals in the Use of Opioids for the Treatment of Pain. Chevy Chase, MD: American Society of Addiction Medicine, 2004.
• (25) Chou R, Fanciullo GJ, Fine PG et al., for the American Pain Society and American Academy of Pain Medicine Opioid Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. Journal of Pain. 2009 Feb;10(2):113-130.
• (26) Cicero TJ, Surratt HL, Kurtz S et al. Patterns of prescription opioid abuse and comorbidity in an aging treatment population. Journal of Substance Abuse Treatment. 2012 Jan;42(1):87-94.
• (27) American College of Physicians (ACP). Evidence-Based Interventions to Improve the Palliative Care of Pain, Dyspnea, and Depression at the End of Life: A Clinical Practice Guideline from the American College of Physicians. Philadelphia, PA: The College, 2008.
• (28) Parran TV Jr. Prescription drug abuse: A question of balance. Alcohol and Substance Abuse. 1997;81(4):253278.
• (29) Wilford BB, Finch J, Czechowicz D et al. An overview of prescription drug misuse and abuse: Defining the problem and seeking solutions. Journal of Law, Medicine and Ethics. 1994 Fall;22(3):197-203.
• (30) American Medical Association (AMA), Council on Scientific Affairs. Drug abuse related to prescribing practices (CSA Rep. C, A-81; Reaffirmed 1991, 2001, 2011). Proceedings of the House of Delegates of the American Medical Association. Chicago, IL: The Association, 1981. References:
• (31) American Medical Association (AMA), Council on Scientific Affairs. Education regarding prescribing controlled substances (Sub. Res. 76; Reaffirmed: 1998, 2008). Proceedings of the House of Delegates of the American Medical Association. Chicago, IL: The Association, 1988.
• (32) Institute of Medicine (IOM) of the National Academy of Sciences (NAS). Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research. Washington, DC: National Academies Press, 2011.
• (33) American College of Physicians (ACP). Evidence-Based Interventions to Improve the Palliative Care of Pain, Dyspnea, and Depression at the End of Life: A Clinical Practice Guideline from the American College of Physicians. Philadelphia, PA: The College, 2008.
• (34) Maine Primary Care Association (MPCA). Health Care Safety Net Series: Opiate Use for Chronic, Non-Cancer Pain (CNCP), First Edition. Augusta, ME: The Association, October 2011.
• (35) National Opioid Use Guideline Group (NOUGG). Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain, Version 5.6. Ottawa, Canada: National Pain Centre, April 30, 2010.
• (36) Utah Department of Health (UDOH). Utah Clinical Guidelines on Prescribing Opioids for Treatment of Pain. Salt Lake City, UT: The Department, February 2009.
• (37) Washington State Agency Medical Directors’ Group (WSAMDG). Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain: An Educational Aid to Improve Care and Safety With Opioid Treatment. Corvallis, WA: Washington Department of Health, 2010.
• (38) Bloodworth D. Opioids in the treatment of chronic pain: Legal framework and therapeutic indications and limitations. Physical Medicine and Rehabilitation Clinics of North America. 2006;17:355-379.
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• (40) Department of Veterans Affairs (VA) and Department of Defense (DoD). Clinical Practice Guideline: Management of Opioid Therapy for Chronic Pain (Version 2.0). Washington, DC: VA/DoD, 2010.
• (41) Nicolaidis C, Chianello T & Gerrity M. Development and preliminary psychometric testing of the Centrality of Pain Scale. Pain Medicine. 2011 Apr;12(4):612-617.
• (42) Webster LR & Webster RM. Predicting aberrant behaviors in opioid-treated patients: Preliminary validation of the Opioid Risk Tool. Pain Medicine. 2005 Nov-Dec;6(6):432-442.
• (43) White AG, Birnbaum HG, Schiller M et al. Analytic models to identify patients at risk for prescription opioid abuse. American Journal of Managed Care. 2009 Dec;15(12):897-906.
• (44) Gourlay D, Heit HA & Caplan YH. Urine Drug Testing in Clinical Practice; The Art & Science of Patient Care. John Hopkins University School of Medicine; 5th Edition, June 2012. Available: (http://www.udtmonograph.com/).
• (45) Starrels JL, Fox AD, Kunins HV et al. They don't know what they don't know: Internal medicine residents' knowledge and confidence in urine drug test interpretation for patients with chronic pain. Journal of General Internal Medicine. 2012 Nov;27(11):1521-1527.
• (46) Smith MY & Woody G. Nonmedical use and abuse of scheduled medications prescribed for pain, painrelated symptoms, and psychiatric disorders: Patterns, user characteristics, and management options. Current Psychiatry Reports. 2005 Oct;7(5):337-343. Chronic Pain: A Widespread Public Health Problem
Emil Annabi M.D. Board Certified and fellowship trained in Anesthesia and Pain Medicine
Today’s Objectives
Discuss the need to balance effective chronic pain management with the appropriate use of pain management techniques
Adequately manage Stratify risk prior to chronic pain starting therapy
Review the potential role of pain management modalities in the treatment of chronic pain
‹#› Chronic Pain
We Have to do Something !
‹#› Chronic Pain Is a Public Health Issue
Pain is the single most common reason for seeking medical
care1 An estimated 9% of American adults report moderate to severe noncancer pain. Of these, a large proportion of those
with severe pain report suboptimal pain management2 The World Health Organization (WHO) and others have advocated the belief that adequate pain management is a
fundamental human right3 “Physicians are in the position to improve the plight of the chronic pain patient but must overcome numerous barriers obstructing
effective treatment.”4
1. Fishman SM. Anesth Analg. 2007;105(1):8-9. 2. “Chronic Pain in America: Roadblocks to Relief.” Available at: http://www.ampainsoc.org/links/roadblocks. Accessed 1/11/10. 3. Brennan F, et al. Anesth Analg. 2007;105(1):205-221. 4. Glajchen M. J Am Board Fam Pract. 2001;14(3):211-218.
‹#› Chronic Pain Is a Public Health Issue
Today nationally recognized guidelines maintain that “chronic opioid therapy can be an effective therapy for carefully selected and monitored
patients with chronic noncancer pain”6 Chronic pain is a significant public health problem that afflicts at least 110 million American adults, more than the total number affected by cancer, diabetes and heart disease
combined7
6. Chou et al. 2009 7. Tsang et al.2008
‹#› Pain Is a Worldwide Problem
In a World Health Organization study of chronic pain, survey data were collected from primary care patients at 15 centers in Asia, Africa,
Europe, and the Americas8 22% of the primary care patients reported persistent pain majority of pain prescriptions are written by primary care
practitioners9, as there is only one pain specialist for every 33,000 patients10
8. Gureje O et al. JAMA. 1998;280(2):147-151. 9. Volkow et al. 2011 10. IOM 2011
6‹#› Costs of Chronic Pain
Annual costs of chronic pain for medical expenses, lost income, and lost productivity are
estimated to be up to $650 billion annually10
10. IOM 2011 ‹#›7 Chronic Pain
Did we do to much?
‹#› Prescription Drugs or Prescription for Death
Figure 1. Drug Overdose Death Rates per 100,000 People
-2011 the Centers for Disease Control (CDC) released a policy impact statement -Overdose death rates more than tripled since 1990 -Opioid pain relievers were present in 74% of the prescription drug overdose deaths that occurred in 2008, more than cocaine and heroin combined -About half of these deaths involved at least one other drug (benzodiazepines, cocaine and heroin) or alcohol
The State of Opioids in America, white paper, Contributors: Emil Annabi, MD; Anjum Bux, MD; David Caraway, MD, PhD; Timothy Deer, MD; Yeshvant Navalgund, MD; Jason Pope, MD; Lynn Webster, MD; Joshua Wellington, MD
‹#› Overdose Rates at an all Time High
National Vital Statistics System. Drug Overdose Death Rates by State. 2008. Available from URL: http://www.cdc.gov/homeandrecreationalsafety/rxbrief/ Accessed 5-31-2012
‹#› Rates of Prescription Painkiller Sales, Deaths and Substance Abuse Treatment Admissions (1999-2010)
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 . http://www.cdc.gov/VitalSigns/PainkillerOverdoses/index.html Accessed 5/31/2012
‹#› Diversion is at the forefront
Figure 2. Sources of Diverted Prescription Medicines
Substance Abuse and Mental Health Services Administration. Results from the 2010 National Survey on Drug Use and Health. Volume 1: Summary of National Findings. Available from URL: http://oas.samhsa.gov?NSDUH/2k10NSDUH/2k10Results.htm#2.16. Website accessed 5/31/2012. ‹#› How does the U.S. rate against the world
-U.S. physicians write more opioid prescriptions and there are more deaths from prescribed medications than anywhere else in the world -U.S. comprises only 4.6% of the world’s population, yet
-Americans consume 80% of the global opioid supply11 -Americans consume 99% of global hydrocodone 12
11.Frieden 2011 12. Manchikanti 2007
‹#› What does it all mean?
CDC. Vital Signs: Overdoses of Prescription Opioid Pain Relievers—United States, 1999-2008. MMWR 2011; 60:1-6. Available at URL : http://www.cdc.gov/homeandrecreationalsafety/rxbrief. Accessed 5-31-2012
‹#› Efficacy of Systemic Opioids
-Among 70 randomized trials on opioids: Nearly all were short-term efficacy (16 weeks or less) Most excluded high-risk patients Substance abuse, medical or psychiatric comorbidities
-Patients are not uniform in response to opioids Dosages Analgesia Intolerable side effects Non-response
-Side effects can limit efficacy
‹#› Centers for Disease Control on Opioid Use
"For chronic pain, narcotics should be the last resort."
November 1, 2011: Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention:
‹#›
The WHO Pain Relief Ladder: Optimizing the Use of Opioids
Freedom From Pain Opioid for Moderate to Severe Pain +/- nonopioid +/- adjuvant Opioid for Mild to Moderate Pain +/- nonopioid +/- adjuvant
Nonopioid +/- adjuvant medications
Adapted from: World Health Organization Pain Relief Ladder. Available at: http://www.who.int/cancer/palliative/painladder/en. Accessed 12/15/09.
‹#› Where Do Opioids Fit in Chronic Pain Management?
Physical Therapies Medications PAIN Neural Blockade Neuroaugmentation Biofeedback-Relaxation Technique
Note: Pain may result in the use of multiple treatment modalities. These modalities can be administered alone or in combination with other therapies. Adapted from: American Society of Anesthesiologists Task Force on Pain Management, Chronic Pain Section. Anesthesiology. 1997;86(4):995-1004.
‹#› Opioid Therapy
But How?
‹#› Balancing Treatment Consideration With Risk Management
• Opioids play an important role in the treatment of chronic pain1 • Despite barriers, there is a need to balance effective chronic pain management
with the appropriate use of opioids13
Treatment of Chronic Pain Managing Risk
• The goal of pain treatment is to decrease pain and improve functioning while
monitoring for adverse effects or aberrant behaviors14 • To do this, HCPs should incorporate risk-management strategies into their
practice, such as Universal Precautions14
13. Trescot AM, et al. Pain Physician. 2008;11(suppl):S5-S62. 14. Gourlay DL, et al. Pain Med. 2005;6(2):107-112.
‹#› Opioid-Related Treatment Risks
HCPs should perform a comprehensive assessment of the potential benefits of chronic opioid therapy compared with the risks and potential for opioid-related adverse events1
Overdose2 Death2
Hyperalgesia3 Constipation4
Opioids Nausea and 5 Pruritis Vomiting4
Hypogonadism4 Sedation4
1. Chou R, et al. J Pain. 2009;10(2):147-159. 4. Chou R, et al. J Pain. 2009;10(2):113-130. 2. Dunn KM, et al. Ann Intern Med. 2010;152(2):85-92. 5. McNicol E, et al.. J Pain. 2003;4(5):231-256. 3. Silverman S. Pain Physician. 2009;12:679-684.
‹#› Multiple Barriers Exist to Opioid Utilization
HCP Communication between Patient Factors HCP and patient3 Factors
Fear of disciplinary Fear of addiction4 and action or prosecution1,2 side effects3
Concern about potential Opioid Socioeconomic and for abuse2 Barriers psychological factors3
Inadequate training3 Poor patient knowledge3
Reimbursement issues3 HCP=healthcare professional.
1. Richard J, Reidenberg MM. J Pain Symptom Manag. 3. Glachen M. J Am Board Fam Pract. 2001;14(3):211-218. 2005;29(2):206-212. 4. McCracken LM, et al. J Pain. 2006;7(10):726-734. 2. Gilson AM, et al. J Pain. 2007;8(9):682-691.
‹#› APS and AAPM Guidelines: Managing Chronic Nonmalignant Pain
Conduct a comprehensive evaluation, including risk Periodically reassess patients stratification
Counsel patients and obtain Anticipate, identify, and treat informed consent opioid-associated adverse events
Integrate nonopioid therapies as Individualize treatment adjunctive treatment
Evaluate potential causes for Consider as-needed therapy for repeated dose escalations; wean breakthrough pain or taper off if necessary
APS=American Pain Society; AAPM=American Academy of Pain Medicine. Chou R, et al. Pain. 2009;10(2):113-130.
‹#› How Can HCPs Assess Risk for Inappropriate Opioid Use?
It may be difficult to determine beforehand who could become problematic users of prescription medications Assessment must include all patients Risk assessment considerations Social evaluation Psychiatric evaluation Presence of aberrant behaviors Personal and family history of substance abuse/use A thorough and respectful approach to patient assessment leads to reduced stigma, improved patient care, and reduced overall risk
Gourlay DL, et al. Pain Med. 2005;6(2):107-112.
‹#› Steps for Long-Term Opioid Therapy to Treat Chronic Pain*
1 Diagnosis With Appropriate Differential
2 Psychological Assessment, Including Risk of Addictive Disorders
3 Informed Consent
4 Treatment Agreement
5 Pre- and Post-Intervention Assessment of Pain Level and Function
6 Appropriate Trial of Opioid Therapy With/Without Adjunctive Medication
7 Reassessment of Pain Score and Level of Function
8 Regularly Assess the “4 As” of Pain Medicine (analgesia, ADL, AB, AE)
Periodically Review Pain Diagnosis and Comorbid Conditions, Including 9 Addictive Disorders
10 Documentation- Prescription Drug Monitoring, Urine Drug Screening, ORT
*Adapted fromTrescot et al. 2006 and Chou et al. 2009
‹#› Risk Stratification and Patient Management
Characteristic Low Risk Moderate Risk High Risk Substance abuse Never Past Current Smoking (nicotine) Never Past Current Family history of None Significant Significant addiction No major diagnoses; Past major diagnoses; Current major Psychosocial factors minor diagnoses current issues with diagnoses untreated treated or stable minor diagnoses or unstable Age Older N/A Younger History of sexual abuse No N/A Yes Controlled prescriptions No N/A Yes lost or stolen Unauthorized Consistently substances in urine drug Initially positive Consistently positive negative screens Recommendations based on risk stratification Primary care with Specialty pain Healthcare setting Primary care specialist support management
Gourlay DL, et al. Pain Med. 2005;6(2):107-112.
‹#› Managing and Preventing Opioid-Related Adverse Events
Adverse Event Clinical Course Management/Prevention Strategy
Constipation1 • Develops to some degree in most patients after • Increased fluid and fiber intake, stool softeners, laxatives initiation or dose increases • May not resolve with continued exposure
Nausea/vomiting1 • May occur after initiation of therapy • Prescription or OTC antiemetic therapy • Tends to diminish over days to weeks of • Both oral and rectal dosage forms available continued exposure
Sedation/clouded • Effects tend to wane over time • Counsel patients regarding driving and work risks 1 mentation • Warn patients about risks of coadministering with other sedating medications
Hypogonadism1 • May develop after prolonged opioid use • Test for hormone deficiencies if patients report loss of libido, impaired sexual function, or fatigue
Pruritis2 • Most common AE with intrathecal or epidural • OTC diphenhydramine may be helpful morphine • Titrate opioid dose to balance itching with pain control
Opioid-induced • Can complicate the course of chronic opioid • Include nonopioids in initial therapy to minimize opioid hyperalgesia (OIH)3 therapy dose • Increase opioid dose to test for tolerance • Reduce or eliminate opioid dose and evaluate • Use opioids with specific properties that may mitigate OIH, or specific agents that are NMDA receptor antagonists
Respiratory • Most dangerous adverse effect of opioid therapy • Physical stimulation prevents significant hypoventilation 4 depression • Rare when the opioid dose is carefully titrated • Opioid antagonists should be used with caution; risk of • Patients receiving chronic opioid therapy withdrawal syndrome and return of pain develop tolerance to respiratory-depressant effects
NMDA, N-methyl-D-aspartic acid. 1. Chou R, et al. J Pain. 2009;10(2):113-130. 3. Silverman, S. Pain Physician. 2009;12:679-684. 2. McNicol E, et al. J Pain. 2003;4(5):231-56. 4. Nicholson B. Drugs. 2003;63(1):17-32. ‹#› What Can Industry Do?
“….and drug manufacturers should modify opioid painkillers so that they are more difficult to tamper with and/or combine them with agents that block the effect of the opioid if it is dissolved and injected.” Centers for Disease Control and Prevention March 12, 2008
CDC Congressional Testimony. United States Senate Subcommittee on Crime & Drugs Committee on the Judiciary and the Caucus on International Narcotics Control: Trends in Unintentional Drug Overdose Deaths Statement of: Leonard J. Paulozzi, MD, MPH, made Wednesday, March 12, 2008. Available at: http://www.cdc.gov/Washington/testimony/2008/t20080312a.htm.
‹#› What has industry done?
‹#› Timeline of Analgesic Development
1917: 1947: 1979: 1969: First clinical First clinical Introduction Introduction use of use of of of ibuprofen23 oxycodone19 methadone21 diclofenac23
Early to 1804 1917 1926 1947 1969 1973 1979 1980 mid-1960s
1804: 1926: Early to 1973: 1980: Morphine First clinical mid-1960s: Introduction of Introduction first use of Introduction ketoprofen and of synthesized18 hydromorphone20 of fentanyl22 sulindac23 piroxicam23
Opioid Nonsteroidal anti-inflammatory drug (NSAID)
18. Trescot AM et al. Pain Physician. 2008;11(suppl 2):S133-153. 19. Kalso E. J Pain Symptom Manage. 2005;29(suppl 5):S47-56. 20. Murray A, Hagen NA. J Pain Symptom Manage. 2005;29(suppl 5):S57-66 21. Drug Text Web site. http://www.drugtext.org/library/books/methadone/section1.html. 22. Stanley TH. J Pain Symptom Manage. 2005;29(suppl 5):S67-71. 23. No authors listed. Br Med J (Clin Res Ed). 1986;292(6529):1190-1191.
‹#› What Opioids Have Come to Market in the Last 2 Years? Oxycontin? Reformulated Abuse Deterrent Zohydro? LA Hydrocodone. Banned in 3 states? Now new formulation! Embeda? LA Morphine. Abuse Deterrent Extampza? Beeswax
‹#› Long-Acting Opioids
Opioid medications are one of the treatment
modalities for chronic pain15,16 Long-acting opioids were designed to
provide16 Maintenance of pain control Steady-state serum levels of medication Improved nighttime pain control with reduced frequency of nighttime dosing
15. MacPherson RD. Pharmacol Ther. 2000;88(2):163-185. 16. Nicholson B. Pain Pract. 2009;9(1):71-81.
‹#› Treatment of Chronic Pain With Long-Acting Opioids
Long-acting opioids are designed to help patients
avoid17,18 Development of early symptoms of opioid withdrawal Increased pain between doses Waking at night to take another dose of pain medication Minute-by-minute “clock-watching” until the next dose can be taken Care should be taken when selecting an opioid product for patients with renal or hepatic dysfunction. As these
impairments are expected to cause an increase in Cmax and area under the curve (AUC), a short-acting agent might be a more appropriate choice
17. Nicholson B. Pain Pract. 2009;9(1):71-81. 18. Weaver MF, Schnoll SH. J Pain Palliat Care Pharmacother. 2002;16(3):5-26. ‹#›3 3 Variable and Unpredictable Response Can Require Alternative Opioid Treatments
In one study of 86 patients started on an ER opioid…
Cumulatively, only 81% of patients were effectively treated after 5 ER opioids
It is difficult to predict which ER opioid will be effective in any given patient
ER=extended-release.
20. Quang-Cantagrel ND et al. Anesth Analg. 2000;90(4):933-937. ‹#› Choosing a Long-Acting Opioid Formulation
Basic Considerations Clinical Considerations •Previous opioid exposure and •History of sensitivity/allergy experience •Administration and absorption •Patient and caregiver preference, limitations attitudes, fears, biases •Match patient’s medical •Compliance issues and constraints circumstances and the drug to: •Convenience issues ― Optimize efficacy •Cost issues ― Optimize duration of effect ― Minimize adverse events (AEs)
19. Fine PG. J Pain. 2001;2(4):195-196.
‹#›3 5 Opioid Switching and Opioid Rotation
The de novo response of patients to opioids is variable Opioid switching is the process of changing from one opioid molecule to another to achieve adequate treatment efficacy and/or tolerability It occurs most commonly when patients are being initiated on opioid therapy Opioid rotation is the process of changing from one opioid molecule to another in patients receiving chronic opioid treatment after they begin to experience A decline in analgesic efficacy Dose escalation Increasing AEs or AEs in the presence of adequate analgesia
21. Slatkin NE. Curr Med Res Opin. 2009;25(9):2133-2150.
‹#›3 6 Opioid Rotation
* INDICATIONS FOR OPIOID ROTATION -Poor tolerability -Poor analgesic efficacy despite aggressive dose titration -Drug-drug interactions -Preference or need for a different route of administration -Change in clinical status (e.g. concern about abuse) -Change in clinical setting that suggests patient may benefit from a different pharmacokinetic profile -Financial or drug availability (e.g. insurance coverage) * TYPES OF OPIOID ROTATION -Change in route of administration -Change of opioid drug (e.g. molecule or formulation)
‹#› What are the differences between Long Acting Opioids vs. Short Acting Opioids
IR hydromorphone is rapidly released36 Blood Concentrations Resulting From Hydromorphone IR Hydromorphone and Hydromorphone delivered via Delivered Via OROS® Technology OROS® technology is released more slowly36 Hydromorphone is released gradually for more steady plasma concentrations than with IR formulations37
Image adapted from Gupta S, Sathyan G. J Pain Symptom Manage. 2007;33(suppl 2):S19-S24. 36. Gupta S, Sathyan G. J Pain Symptom Manage. 2007;33(suppl 2):S19-S24. 37. Shram MJ et al. J Clin Psychopharmacol. 2010;30(1):25-33. ‹#› Steady-State Plasma Concentrations of IR Hydromorphone and Hydromorphone ER
Steady-state concentrations Steady-State Blood Concentrations Resulting of hydromorphone delivered From IR Hydromorphone and Hydromorphone via OROS® technology are Delivered Via OROS® Technology achieved after 3 or 4 days of dosing33 When steady-state blood concentrations are reached, hydromorphone delivered via OROS® technology achieves a more even plasma- concentration profile than IR hydromorphone at comparable daily doses33 The peak-to-trough fluctuation is35 Hydromorphone delivered via OROS® technology
maintains 50% Cmax across the entire dosing interval35
Image adapted from EXALGO prescribing information. 33. EXALGO [prescribing information]. Hazelwood, MO: Mallinckrodt Brand Pharmaceuticals, Inc.; 2010. 35. Moore KT et al. J Opioid Manag. 2008;6(5):351-358. ‹#› Opioid Therapy
Keep SAO to a minimum Chronic pain needs LAO Keep pill counts to a minimum Routine UDS Always check AZPMP ORT
‹#› Interventional Therapy
Don’t forget other therapies
‹#› Nerve Blocks (I)
Diagnostic: local anesthetic only, to clarify mechanism or simulate effects of therapy Therapeutic: anesthetize a site or pathway temporarily (local anesthetic) or “permanently” (lytic agent), or reduce inflammation (corticosteroid) A block may be both diagnostic and therapeutic, eg, sympathetic block or trigger-point injection
‹#› Nerve Blocks (II)
Common blocks for chronic pain include Trigger-point injection Tourniquet or Bier block Peripheral nerve injection (eg, ilioinguinal, lateral femoral cutaneous, greater occipital) Paravertebral (nerve root) injection Epidural injection Intra-articular (eg, facet, SI) injection Sympathetic block (cervical, lumbar) Plexus block (celiac, hypogastric)
‹#› Nerve Blocks (III)
Case reports, preclinical data support long- lasting effects of local anesthetic blockade RCTs support lytic celiac block However, unclear how much clinical improvement reflects placebo effects, irrelevant cues, systemic absorption of local anesthetic, expectations Side effects possible Rarely successful as a “stand-alone” strategy for chronic pain
‹#› Trigger-Point Injection III
Reproduced with permission from Simons DG, et al. Travell & Simons’ Myofascial Pain and Dysfunction: The Trigger Point Manual. Vol. 1. 2nd ed. Philadelphia, Pa: Williams & Wilkins; 1999:160.
‹#› Trigger-Point Injection III
Reproduced with permission from Simons DG, et al. Travell & Simons’ Myofascial Pain and Dysfunction: The Trigger Point Manual. Vol. 1. 2nd ed. Philadelphia, Pa: Williams & Wilkins; 1999:159.
‹#› Paravertebral (Nerve Root) Injection
Diagnostic Establish or confirm anatomic mechanism of pain (eg, atypical dermatomal distribution in disk disease or multilevel foraminal stenosis) Therapeutic Deposit local anesthetic plus glucocorticoid via paravertebral and/or transforaminal approach Technique Fluoroscopy or CT essential to validate, document needle placement Radiopaque contrast outlines/tracks root
‹#› Lumbar Selective Nerve Root Block
‹#› Epidural Injection (I)
Employed for decades using various techniques, materials, and patients Poor documentation of diagnosis, pain, technique, outcomes Limited RCT evidence of efficacy in subpopulations, but most reports are case series Techniques (glucocorticoid + local anesthesic) Translaminar Transforaminal Caudal (useful if prior lumbar surgery, scarring)
‹#› Epidural Injection (II)
Applied for symptomatic relief in Disk protrusion with radiculopathy Spinal stenosis (circumferential or foraminal) Acute pain, local inflammation of vertebral fracture ( subsequent vertebroplasty) ? Acute herpes zoster, using local anesthetic alone May facilitate rehabilitation, avert surgery when applied within multidisciplinary framework
‹#› Interlaminar Epidural Steroid Injection
‹#› Transforaminal Epidural Injection
‹#› Transforaminal Epidural Injection
‹#› Caudal ESI
‹#› Intra-Articular Injection
Facet, large joints, sacroiliac most common Diagnostic Clarify clinical impression of a “facet syndrome” or “SI joint pain” (Facet:) simulate results of potential spinal fusion or denervation of medial branch of dorsal ramus Therapeutic (local anesthetic + glucocorticoid) Reduce inflammation, pain Increase mobility, facilitate rehabilitation Controversy as to efficacy and effectiveness
‹#› Lumbar Facet Nerve Block
‹#› Lumbar Facet Nerve Block
‹#› SacroIlliac Joint Injection
‹#› Other Joint Injections
Shoulder Knee Hip
‹#› Shoulder
‹#› Knee
‹#› Hip
‹#› Sympathetic Block
Diagnostic Superior cervical (“stellate”) ganglion Lumbar Therapeutic CRPS of upper, lower extremity Facial neuralgias Technique Local anesthetic Neurolytic
‹#› Stellate Ganglion Block
‹#› Lumbar Sympathetic Block (Lateral View)
‹#› Other Interventions
‹#› Discography
Disc injection to determine relationship of abnormal morphology on imaging studies to LBP symptoms X-ray guided Pressure monitoring Normal control Morphology of disc on x-rays and CT Only study able to assess for pain
‹#› Nucleoplasty
‹#› Dorsal Column Stimulators and Intrathecal Pumps
‹#› Dorsal Column Stimulators
‹#› Dorsal Column Stimulators
‹#› Peripheral Stimulation
‹#› Peripheral Stimulation
‹#› Peripheral Stimulation-Occipital Stimulation
‹#› Peripheral Stimulation-Facial Stimulation
‹#› Peripheral Stimulation-Facial Stimulation
‹#› Intra-Thecal Pump
‹#› Thank You!!!
Questions?
‹#› PRIMARY CARE UROLOGY POSSIBLE TOPICS
• LOW T • BPH • PSA SCREENING • OVERACTIVE BLADDER AND URGE INCONTINENCE • INFERTILITY • PROSTATE CANCER • UROLOGIC EMERGENCIES THAT PRESENT IN A PRIMARY CARE OFFICE TODAYS TOPICS
• LOW T • BPH • PSA SCREENING HYPOGONADISM AND TESTOSTERONE REPLACEMENT THERAPY
• LOW T OR TRT IS A BIG BUSINESS • 2.3 MILLION PRESCRIPTIONS IN 2013, UP FROM 1.3 MILLION IN 2009 • DIRECT TO CONSUMER MARKETING CAMPAIGN FOR ”LOW T” IS USED AS AN EXAMPLE FOR STUDENTS AT BUSINESS SCHOOLS • DRAMATIC DECREASE AFTER FDA WARNINGS OUTLINE
• WHAT IS HYPOGONADISM? • HOW IS HYPOGONADISM DIAGNOSED? • WHAT ARE THE CLINICAL MANIFESTATIONS? • WHAT ARE THE AVAILABLE TREATMENT OPTIONS? • WHAT ARE THE RISKS OF TRT? • DOES TESTOSTERONE REPLACEMENT WORK? WHAT TRT SHOULD NOT BE USED FOR
• BODY BUILDING • PERFORMANCE ENHANCEMENT • ANTI-AGING • NOT FOR MEN WITH NORMAL TESTOSTERONE • NOT FOR MEN WITHOUT PRIOR LAB WORK WHY IS T IMPORTANT
• VITAL FOR MAINTENANCE AND DEVELOPMENT OF SEXUAL FUNCTION IN MEN • STIMULATES ERYTHROPOIESIS • INCREASES LEAN MUSCLE MASS • MAINTAINS BONE GROWTH • SUPPRESSES ADIPOSE TISSUE DEVELOPMENT • POSITIVE EFFECTS ON MOOD AND COGNITION WHAT IS HYPOGONADISM?
• CLINICAL AND BIOCHEMICAL SYNDROME • ANDROGEN DEFICIENCY • MULTIPLE CAUSES, FAILURE OF HPT AXIS HPT AXIS
• HYPOTHALMUS LHRH • ANTERIOR PITUITARY LH FSH • TESTIS LEYDIG CELLS T NEGATIVE FEEDBACK ON LHRH AND LH/ FSH • 90 PERCENT LEYDIG CELLS 10 PERCENT ADRENAL GLAND PRIMARY
• HYPERGONADOTOPIC HYPOGONADISM – LESS COMMON • RESULTS FROM FAILURE OF TESTICLE • LOW T, ELEVATED LH/FSH, LOW SPERM COUNT • THINK TRAUMA, GONADOTOXINS, INFECTION SECONDARY
• HYPOGONADOTROPIC HYPOGONADISM – MORE COMMON • RESULTS FROM DEFECT OUTSIDE THE TESTICLE • LOW T, LOW TO NORMAL LH/FSH • MULTIPLE CAUSES – DIABETES, METABOLIC SYNDROME, HYPERTENSION, CORTICOSTEROIDS, OPIOIDS, PRIOR USE OF TESTOSTERONE MIXED CAUSES
• USUALLY ONSET ASSOCIATED WITH AGING -- MOST COMMON CAUSE • AGING HYPOTHALMUS DECREASED PRODUCTION OF GONADOTROPINS • PRIMARY TESTICULAR FAILURE • CHANGES IN ANDROGEN RECEPTOR FUNCTION • EFFECTS ON T METABOLISM THAT LEAD TO DECREASE FUNCTION REGARDLESS OF T LEVELS PHYSICAL SIGNS
• INCREASED BODY FAT, BMI • REDUCED MUSCLE BULK AND STRENGTH • LOW BONE MINERAL DENSITY • LOSS OF BODY HAIR SYMPTOMS
• DECREASED ENERGY AND MOTIVATION • DIMINISHED LIBIDO • ERECTILE DYSFUNCTION • DIMINISHED WORK PERFORMANCE • POOR CONCENTRATION • SLEEP DISTURBANCE • DEPRESSION MEDICAL COMORBIDITY
• INCREASE RISK OF ATHEROSCLEROSIS • INCREASE IN MYOCARDIAL INFARCTION • INCREASE ADIPOSE AND INSULIN RESISTANCE • DIABETES • FRACTURE RISK • MORTALITY DIAGNOSIS
• HISTORY NON-SPECIFIC AND FOUND IN NUMEROUS CONDITIONS • PE DO A DRE • LAB INCLUDE A PSA, THYROID AND HEMOGLOBIN • DEXA SCAN TESTING
• USUALLY GET A TOTAL FREE PLUS BOUND • ONLY 2 PERCENT IS FREE • 40 -50 PERCENT BOUND TO ALBUMIN, 50 – 60 PERCENT BOUND TO SHBG • VARIOUS CONDITIONS CAN INCREASE AND DECREASE SHBG • CIRCADIAN RHYTHM IS IMPORTANT MAINLY IN YOUNGER MEN • IN YOUNGER MEN CHECK IN AM AND IT DOESN’T MATTER SO MUCH IN OLDER MEN GUIDELINES
• NOT ESTABLISHED , BELOW IS A CONSENSUS OF OPINION • VARIES FROM LAB TO LAB • > 350 NG/DL – DO NOT REQUIRE TREATMENT • < 230 NG/DL (WITH SYMPTOMS) MAY REQUIRE TREATMENT, INCLUDE AN LH IN YOUNGER MEN • 230 – 350 – REPEAT LABS WITH CALCULATION OF FREE TESTOSTERONE RECOMMENDATION
• FIRST CHECK A TOTAL TESTOSTERONE • IF NORMAL AND VERY SYMPTOMATIC REPEAT WITH TOTAL AND FREE • IF ABNORMAL OR LOW NORMAL CONFIRM WITH REPEAT TOTAL AND FREE • IF LESS THAN 150 CHECK LH, FSH, PROLACTIN • OCCASIONALLY YOU MIGHT PICK UP ON MRI A PITUITARY TUMOR T<150, SEVERELY LOW LH AND ELEVATED PROLACTIN TREATMENT/CONTRAINDICATIONS
• METASTATIC PROSTATE CANCER • BREAST CANCER • UNEVALUATED PROSTATE NODULE NEED TO BE REFERRED BEFORE TREATMENT • PSA > 4 NEED TO BE REFERRED BEFORE TREATMENT • HCT > 50 NEED TO BE REFERRED TO HEMATOLOGY • SEVERE BPH SHOULD BE REFERRED BEFORE TREATMENT • POORLY CONTROLLED OR SEVERE CHF, ANGINA, RECENT MI TREATMENT OPTIONS
• ORAL • INJECTION • TRANSDERMAL • IMPLANT ORAL
• NOT USED IN US • LIVER TOXICITY • BUCCAL TABLETS • NASAL FORMULATION – RECENT NO EXPERIENCE TID PUMP EACH NOSTRIL INJECTIONS
• SHORT ACTING T CYPIONATE AND T ENANTHATE DOSES EVERY 1-2 WEEKS • CHEAPEST CHOICE • PAIN AT INJECTION SITE • ROLLER COASTER EFFECT ON SYMPTOMS FROM SHORT TERM • LONG TERM AVEED IM 750 FIRST TWO INJECTIONS 4 WEEKS APART, THEN EVERY 10 WEEKS • REQUIRES TRAINING PROGRAM TO AVOID RISKS • SIDE-EFFECT S POME, ANAPHYLAXIS, PATIENT MUST REMAIN IN OFFICE 30 MINUTES AFTER INJECTION TRANSDERMALS
• PATCHES APPLIED DAILY, SKIN IRRITATION AND LESIONS • GELS USE DAILY LESS IRRITATING BUT HAVE THEORETICAL PROBLEM OF TRANFERENCE IMPLANT
• TESTOSTERONE PELLETS IN SUBCUTANEOUS TISSUE OF UPPER BUTTOCKS • USE ONLY AFTER DEMONSTRATING IMPROVEMENT WITH SHORT ACTING AGENT • PROCEDURE RELATED SIDE EFFECTS • EXTRUSION ALTERNATIVES OFF LABEL
• CLOMIPHENE CITRATE SELECTIVE ESTROGEN RECEPTOR MODULATOR PRESERVES FERTILITY • AROMATASE INHIBITORS USE SHORT TERM IN MEN WITH HIGHER LEVELS OF ESTROGEN • HUMAN CHORIONIC GONADOTROPIN WORKS ON LEYDIG CELLS
MONITORING
• ON SHORT ACTING INJECTIONS CHECK TESTOSTERONE LEVELS 6 WEEKS AFTER INITIATING THERAPY, CHECK IT MIDCYCLE NOT AT END OR BEGINNING, IDEAL RANGE BETWEEN 300 AND 700, ADJUST ACCORDINGLY. • FOR TOPICALS RECHECK AROUND A MONTH, CHECK 3 TO 12 HOURS AFTER APPLYING THE GEL. • FOR LONG ACTING INJECTIONS OR PELLETS CHECK RIGHT BEFORE INJECTION • MONITOR PSA AND HCT AND LFT AT 3 MONTHS AND THEN YEARLY RISKS
• CARDIOVASCULAR • PROSTATE CANCER • BPH • ERYTHROCYTOSIS • INFERTILITY • OBST. SLEEP APNEA (WEAK) CARDIOVASCULAR
• 2010 STUDY PROMPTED FDA WARNING • FLAWED STUDY SHOWED INCREASED RISK FOR MI AND STROKE • NEED TO DISCLOSE TO PATIENTS AND TELL THEM FURTHER STUDIES ARE NEEDED BUT CURRENTLY EVIDENCE IS NOT COMPELLING
PROSTATE AND PSA RISK
• MINIMAL CHANGE IN PSA IN NORMAL SUBJECTS • SATURATION THEORY – FINITE NUMBER OF ANDROGEN RECEPTORS • UNDER CERTAIN CIRCUMSTANCES MANY UROLOGISTS USE TESTOSTERONE IN PATIENTS WITH A HISTORY OF PROSTATE CANCER, DO NOT RECOMMEND THIS BE DONE IN PRIMARY CARE SETTING • TESTOSTERONE CAN INCREASE PSA AND PROSTATE SIZE IN THE FIRST 6 MONTHS OF TREATMENT, MONITOR IN NEEDED BUT RELATIONSHIP BETWEEN TESTOSTERONE AND WORSENING BPH SYMPTOMS IS UNPROVEN FERTILITY
• TESTOSTERONE THERAPY INHIBITS LHRH AND FSH • LEADS TO IMPAIRED SPERMATOGENESIS • MOST MEN BUT NOT ALL WILL RESUME NORMAL SPERMATOGENESIS AFTER STOPPING THERAPY • PLEASE COUNSEL YOUNG MEN APPROPRIATELY ABOUT THIS RISK DOES T REPLACEMENT WORK?
• RECENT RANDOMIZED STUDY NEJM 2016 FEB • MODERATE INCREASE IN SEXUAL ACTIVITY • SLIGHT IMPROVEMENT IN MOOD • NO BENEFIT TO VITALITY OF PHYSICAL ACTIVITY MEASURES • NO CONCLUSIONS REGARDING RISKS DOCUMENTED BENEFIT SUPPORTIVE DATA BUT NOT RANDOMIZED
• MUSCLE MASS • BONE DENSITY • ADIPOSITY, GLUCOSE METABOLISM • CARDIOVASCULAR DISEASE • SEXUAL FUNCTION, LIBIDO MUCH MORE RESPONSIVE THAN JUST ED • MOOD • COGNITIVE FUNCTION BPH AND PSA SCREENING
PROSTATE FUNCTION
• CONTRIBUTES TO CONTINENCE MECHANISM • PRODUCES PROSTATIC FLUID FOR SEMINAL EMISSION • ANDROGEN DEPENDENT – DHT • MAIN SOURCE OF PSA BPH NATURAL HISTORY
• BENIGN PROLIFERATION OF PROSTATIC STROMA AND EPITHELIAL CELLS • HISTOLOGIC EVIDENCE – 75% OF MEN OVER AGE 60 • PRESENCE OF BPH DOES NOT EQUATE TO EXPERIENCING SYMPTOMS • PROSTATE VOLUME INCREASES WITH ADVANCING AGE (1.6% PER YEAR) LOWER URINARY TRACT SYMPTOMS LUTS • AFFECTS 15 – 60 % OVER AGE 40 • CAUSES BLADDER (IRRITATIVE) AND PROSTATE (OBSTRUCTIVE) • RESULTS IN: • IMPAIRED QUALITY OF LIFE • RISK OF FALLING • URINARY RETENTION AND RENAL COMPROMISE • 1 BILLION IN HEALTH COST ANNUALLY
SYMPTOMS OF LUTS • BLADDER (IRRITATIVE) • PROSATE (OBSTRUCTIVE) • URGENCY • HESITANCY • FREQUENCY • WEAK FLOW • NOCTURIA • INTERMITTENCY • INCONTINENCE • DRIBBLING • STRAINING • INCOMPLETE EMPTYING LUTS IS A MIXED DISORDER SEQUELAE OF BPH
• URINARY TRACT INFECTION • BLADDER STONES • HYDRONEPHROSIS • BLADDER TRABECULATION • RENAL FAILURE • URINARY RETENTION EVALUATION
• HISTORY AND PHYSICAL • URINALYSIS – PYURIA? GLUCOSURIA? • VALIDATED QUESTIONNAIRE OF SYMPTOMS • VOIDING AND FLUID INTAKE DIARY • PSA (OPTIONAL IF LIFE EXPECTANCY < 10 YRS OR HEALTHY >75 YEARS OLD)
LUTS OTHER CAUSES
• DIABETES, CHF, COPD, GI PROBLEMS • SLEEP APNEA • ASSOCIATED MEDICATIONS/FLUIDS • BLADDER/PROSTATE CANCER • URETHRAL STRICTURE PATIENT EVALUATION OPTIONAL TESTS
• UROFLOW • POST VOID RESIDUAL SCAN • URODYNAMIC EVALUATION • URINE CYTOLOGY • PROSTATIC ULTRASOUND • CYSTOSCOPY
SHOULD WE BE SCREENING FOR PROSTATE CANCER?? IS IT WORKING?
USPSTF PSA TESTING RECOMMENDATIONS DRAFT FORM, OCT 7, 2011- ANN INT MED
• THE U.S. PREVENTIVE SERVICES TASK FORCE (USPSTF) RECOMMENDS AGAINST PROSTATE-SPECIFIC ANTIGEN (PSA)-BASED SCREENING FOR PROSTATE CANCER. THIS IS A GRADE D RECOMMENDATION • THIS RECOMMENDATION APPLIES TO MEN LESS THAN 75 YEARSOLD IN THE U.S. POPULATION THAT DO NOT HAVE SYMPTOMS THAT ARE HIGHLY SUSPICIOUS FOR PROSTATE CANCER REGARDLESS OF AGE, RACE, OR FAMILY HISTORY. • 2017 DRAFT RECOMMENDATIONS GRADE C FOR MEN UNDER 70 , GRADE D FOR OVER 70
IMPORTANT FACTS TO CONSIDER ABOUT PSA SCREENING RECOMMENDATIONS • NO UROLOGY, RADIATION OR MEDICAL ONCOLOGY REPRESENTATIVE ON TASK FORCE • IN PSA ERA, DIAGNOSIS OF ADVANCED CAP HAS DECREASED > 75% • GLOBALLY CAP HAS DECREASED IN COUNTRIES WHERE SCREENING IS PRACTICED; HAS STAYED STABLEOR INCREASED IN COUNTRIES THAT DON’T SCREEN • CAP ARISES AND PROGRESSES SILENTLY • SYMPTOMS OFTEN REFLECT INCURABLE STATE
AUA RECOMMENDATIONS • FOCUS ON MEN AGES 55-69 • NOT RECOMMENDED FOR AVERAGE-RISK * MEN 40-54, AFTER AGE 70, OR FOR MEN WITH AVERAGE LIFE EXPECTANCY OF LESS THAN 10-15 YEARS • SHOULD INCLUDE A THOROUGH DISCUSSION OF RISKS AND BENEFITS OF SCREENING BETWEEN PATIENT AND PHYSICIAN • 40- 54 YRS OLD - MEN AT HIGH RISK- FAMILY HISTORY OR AFRICAN-AMERICAN RACE SHOULD BE CONSIDERED FOR PSA TESTING
BPH TREATMENT OPTIONS
• ACTIVE SURVEILLANCE / BEHAVIOR MODIFICATION • MEDICAL THERAPY – PHARMACOTHERAPY • SURGICAL THERAPY ALPHA 1 ADRENERGIC BLOCKERS • UROSELECTIVE -- TAMSULOSIN, SILDOSIN, ALFUZOSIN • NON UROSELECTIVE – TERAZOSIN, DOXAZOSIN • TREATS “DYNAMIC “ COMPONENT OF BPH • FAST RELIEF OF SYMPTOMS – DAYS TO WEEKS • INHIBITS ACTIVATION OF ALPHA-1 ADRENERGIC RECEPTORS • RELAXES PROSTATIC AND BN SMOOTH MUSCLE • DOES NOT ALTER PROSTATE VOLUME OR GROWTH • SIDE-EFFECTS: DIZZINESS, ORTHOSTATIC HYPOTENSION, IMPOTENCE, EJACULATORY DIFFICULTIES
5 –ALPHA REDUCTASE INHIBITORS • BLOCKS CONVERSION OF TESTOSTERONE TO DIHYDROTESTOSTERONE, WHICH INHIBITS PROSTATE GROWTH • BLOCKAGE OF PATHWAY 2 -FINASTERIDE 5 MG DAILY • BLOCKAGE OF PATHWAY 1 AND 2 -DUTASTERIDE 0.5 MG DAILY • DECREASED EJACULATORY VOLUME • ERECTILE DYSFUNCTION • DECREASED LIBIDO • »GYNECOMASTIA
5- ALPHA REDUCTASE INHIBITOR
• ACTS ON STATIC COMPONENT OF PROSTATE • LONG TERM THERAPY • REDUCES PROSTATE VOLUME • WORKS BEST WITH LARGER GLANDS • REDUCES RISKS OF RETENTION AND SURGERY USE OF PDE5 INHIBITORS AND BPH
• 5-PDE-INHIBITORS INCREASE NO/CGMPCONCENTRATIONS IN SMOOTH MUSCLE OF PENIS, URETHRA, BLADDER NECK • ENHANCED BLADDER EMPTYING AND PROSTATIC RELAXATION • FDA APPROVAL OF TADALAFIL FOR TREATMENT OF LUTS
MINIMALLY INVASIVE SURGERY
• UROLIFT • REZUM • MICROWAVE MODERATELY INVASIVE SURGERY
• LASER TUR • BUTTON BIPOLAR MORE INVASIVE SURGERY
• CLASSIC TURP • OPEN SIMPLE PROSTATECTOMY • INCREASED RISKS OF BLEEDING, IMPOTENCE AND INCONTINENCE SUMMARY POINTS
• PHARMACOLOGY GOOD INITIAL TREATMENT • PDE-5 INHIBITORS PLAYING LARGER ROLE IN TREATMENT • SURGICAL OPTIONS LESS INVASIVE TODAY • OTC PRODUCTS NOT GENERALLY RECOMMENDED Hypogonadism
Normal aging in men is accompanied by a decline in testosterone (T) production and function that may contribute to detrimental changes to overall male health. Hypogonadism displays numerous clinical manifestations and the degree and timing of onset is variable and not universal for all men. This can lead to difficulty in diagnosis and treatment. A typical man with low T may be between the age of 40 to 69 and present with signs and symptoms of fatigue, low energy, depressed mood and low sexual drive.
Low T or symptomatic late-onset hypogonadism is a clinical and biochemical syndrome characterized by deficiency in androgen activity which may affect the function of multiple organ systems and result in significant detriment in quality of life. More than 500,000 new cases may be diagnosed each year but remains under diagnosed and treated. Numerous theories to its cause are present with a combination of factors contributing to the problem. These include aging hypothalamus with decrease production of gonadotropins, primary testicular failure, changes in androgen receptor activity/function, and effects on T metabolism that lead to decrease function regardless of T levels.
Presentation of the hypogonadal patient is variable which can make diagnosis difficult. Common signs and symptoms include low energy, depressed mood, sleep disturbances, depressed cognition, impotence, and low libido. But low T may also unknowingly contribute to systemic disease including metabolic syndrome, increased cardiovascular risk, and osteoporosis.
Clinical diagnosis is problematic because neither low T nor symptoms are truly diagnostic. The most common symptoms - tiredness, depressed sexual drive, and dysphoria - should tip the physician to further evaluate for hypogonadism. Also, several medical conditions are associated with low SHBG levels and hypogonadism including diabetes and renal failure. Several screening questionnaires are available to aid in the diagnosis, but unfortunately are not specific. Initial testing should include T levels obtained between 8am and 11am, with total T being sufficient. Any low level should be confirmed and may include free testosterone, SHBG level, LH, prolactin if clinically warranted. Unfortunately, there is much variability in T level reporting and the parameters for hypogonadism. This is currently under scrutiny by medical groups and societies with hope to standardized reporting to ensure better research, trials and patient care.
Intramuscular injections reliably increase T levels for hypogonadal men but T levels may reach supraphysiologic levels and the normal circadian rhythm is absent. This will make patients complain of a "roller coaster effect". Also, current preparations available require repeat injections typically every 2-3 weeks. Oral preparations are rarely used in US due to erratic effects on T levels and problems with liver toxicity and hyperlipidemia. Transdermal patches and gels are popular yet require daily administration with definite risk for transference to others. Testosterone pellets are implanted subcutaneously every 3-6 months. It has benefits with fewer administrations and no risk of transference. But T pellet implantation requires a procedure and there is risk of extrusion of pellets, poor absorption and other procedure site side-effects. A new, recently FDA approved formulation, testosterone undecanoate, is given as an intramuscular injection every 10 weeks after first month of therapy but has potential risk of POME (pulmonary oil microembolism) and anaphylaxis. The use of alternatives to testosterone therapy for hypo gonadal men will likely become more main stream in the coming years including selective estrogen receptor modulators, aromatase inhibitors and others.
A prior history of prostate or breast cancer is considered an absolute contraindication for hormone replacement. This "truth" has been questioned particularly in light of current treatment of low risk prostate cancer. Hormone replacement in hypogonadal men with clinically cured or untreated low risk disease has been studied showing no significant increase risk of recurrence or progression. However, most practicing urologists discourage T replacement for these men. The belief of increase prostate size or PSA thus worsening lower urinary tract symptoms or risk of prostate cancer has not been demonstrated in several short term studies. Long term effects of T replacement are not well known at this time. However, recent studies in at risk men have demonstrated an increase in cardiovascular events on testosterone therapy. These studies suggested an increase in the risk of heart attack and stroke in the population of men receiving testosterone therapy.
Given these findings, the FDA recently released a statement and mandated a label change for testosterone products which can be found at the FDA website: http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm. Future, randomized studies should hopefully shed more light on the possible cardiovascular risks associated with hormone replacement in men. T replacement may also lead to increase red blood cell mass and hemoglobin. Side effects from excessive supplementation of T and other rare problems include infertility, testicular atrophy, priapism, fluid retention, liver toxicity (uncommon with current preparations), hepatitis and hepatic tumors, sleep apnea and gynecomastia. Infertility caused by T supplementation may require treatment with gonadotropins to increase testosterone and attempt to restore normal spermatogenesis. Side effects from the route of administration may also occur.
Hypogonadism is a common yet under recognized problem in aging men. Not only will low T level lead to sexual side effects it may also effect psychological, physical and overall wellbeing of older men. Replacement is indicated for men who have signs and symptoms of hypogonadism accompanied by subnormal serum T levels. T supplementation can provide important health benefits to these hypogonadal men. T supplementation requires medical surveillance in order to identify early signs of possible adverse effects.
References 1. Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010; 95:2536-59 2. Morales A, Morley J and Heaton JPW. Androgen deficiency in the aging male. Campbell Walsh-Urology, 9th Edition. Philadelphia, WB Saunders Elsevier; 2007: vol. 1, 850 3. Rhoden EL and Morgentaler A. Risks of testosterone replacement therapy and recommendations for monitoring. N Engl J. 2004; 350: 482-92
1. Define Provider Burnout 2. Compare and contrast Burnout versus Depression 3. List ways to prevent Burnout 4. Describe options for those who are are already burned out
1.What is the definition of Provider Burnout? a. Depersonalization b. Emotional exhaustion c. Loss of sense of accomplishment d. All of the above
1.What is the definition of Provider Burnout? a. Depersonalization b. Emotional exhaustion c. Loss of sense of accomplishment * d. All of the above
1. Depersonalization 2. Emotional exhaustion 3. Loss of sense of accomplishment
Depersonalization *thinking of patients like objects such as pawns on a chess board *e.g “The cough in room 4” instead of “Mrs. Daniels with a bad cough in room 4.”
Emotional Exhaustion *emotionally drained *feel empty *not being able to care about things like used to *compassion fatigue
Emotional Exhaustion *blaming patients *blaming others *blaming Cerner
Loss of sense of accomplishment *feeling like “why bother?” “What’s the use?” *doubt that your work makes any difference *loss of meaning *feeling a loss of purpose
Loss of sense of accomplishment *being angry *being sarcastic *being cynical 1. Depersonalization 2. Emotional Exhaustion 3. Loss of sense of accomplishment
2. Choose the incorrect statement about burnout and depression. a. Taking a vacation usually helps decrease Burnout. b. Taking a vacation usually helps decrease depression. c. Burnout affects work life. d. Depression affects all aspects of life.
2. Choose the incorrect statement about burnout and depression. *a. Taking a vacation usually helps decrease Burnout. b. Taking a vacation usually helps decrease depression. c. Burnout affects work life. d. Depression affects all aspects of life.
Burnout Depression
Taking a vacation Taking a vacation usually doesn’t help usually decrease Burnout. does help decrease Depression. Burnout Depression
Occurs in work life. Occurs in all aspects of life. Burnout Depression
Erosion of the soul. No erosion of the soul. Maslach Burnout Inventory defines Burnout as erosion of the soul caused by a deterioration of values, dignity, spirit, and will. Stress – being drained and able to recover between shifts
Burnout – being drained and NOT able to recover between shifts Burnout is a big problem. Over or under age 55 providers? Over age 55 – 25% burnout rate Under age 55 - 37% burnout rate
Which of the following are ways to prevent Provider Burnout? ◦ a. meditation, mindfulness and movement ◦ b. yoga and dance ◦ c. sleeping and eating well ◦ d. get bodywork (OMT)Osteopathic Manipulation, massage, spa treatments) ◦ e. remind yourself of the difference you make in patient’s lives as well as their families ◦ f. appreciate all the things that go well in a day ◦ g. all of the above ◦
Which of the following are ways to prevent Provider Burnout? ◦ a. meditation, mindfulness and movement ◦ b. yoga and dance ◦ c. sleeping and eating well ◦ d. get bodywork (OMT )Osteopathic manipulation, massage, spa treatments) ◦ e. remind yourself of the difference you make in patient’s lives as well as their families ◦ f. appreciate all the things that go well in a day ◦ *g. all of the above ◦
When you come to the end of your rope, tie a knot and hang on.
Franklin D Roosevelt 32nd president of US. He served for 12 years.
energy is sapped
energy and passion for medicine has been drained
Decrease the drain on energy.
Make more energy deposits into the energy bank account.
*Arrive at work a little earlier. *Create Auto Text (Cerner) for faster charting *Create a new completed note *Limit use of snooze button because it robs you of stage 1 sleep * Sleep 7-8 hours a night
How do you increase energy? make deposits into your energy bank account. Areas to make energy deposits into *restoring your passion for medicine *self care to feel good *meditation *mindfulness *movement *nutrition
4. Do more of what inspires you in medicine. 5. Change your passwords to encourage/uplift. 6. Appreciate what goes well in a day. 7. At lunch time think about one thing that went well during the morning. 8. When leave the office think about one thing that went well in the afternoon.
The 5 Love Languages by Chapman *words of affirmation *quality time *acts of service *physical touch *receiving gifts
*sex – Slow Sex by Richardson Come As You Are by Nagoski
BODY *Osteopathic Manipulative Techniq (OMT) *massage *acupuncture *Zero Balancing *spa treatments *pedicures
Mind and Soul *Attending church, faith, spirituality *Looking at things in a positive way *Journaling
*20 minutes a day of meditation for 8 weeks increases telomerase. This protects the the telomeres at the end of our chromosones. *start with doing 5 minute guided meditations on YouTube at bedtime
Do something you enjoy. *Dance *Tai Chi *Sports *Martial arts *Walking *Yoga
Withdrawing from people gone is the morning greeting speak less to colleagues speak less to medical assistant decrease time with family not making time for a beloved hobby
Road rage increases Increase in complaining Being less flexible Increase in anger
Increase in sarcasm Decrease in empathy More irritable and cranky Decrease in efficiency (working harder but not getting more done) – This is key to recognize in yourself and other so actions can be taken to decrease burnout. Fantasizing about another career
4. Options for burned out providers include which of the following. a. Mentor coaching b. Weekly Cognitive Behavioral Therapy c. Share with a trusted friend d. Get confidential help for substance abuse from the Arizona Medical Board e. All of the above
4. Options for burned out providers include which of the following. a. Mentor coaching b. Weekly Cognitive Behavioral Therapy c. Share with a trusted friend d. Get confidential help for substance abuse from the Arizona Medical Board e. All of the above
Reading and coaching ◦ www.thehappymd.com Dike Drummond MD does coaching with providers Free book and articles
The Artist’s Way by Julia Cameron
Kitchen Table Wisdom by Rachel Naomi Remen MD Rachelremen.com
Mentor coaching Weekly Cognitive Behavior Therapy (CBT)
Share with a trusted friend.
10% among US population
15% among providers Arizona Medical Board sponsors the Physician Health Program for MDs and PAs Addiction specialist runs it 85-90% success rate volunteer enrollment does not trigger reporting to Federation of State Medical Boards or National Practitioner Data Bank www.azmd.gov (480) 551-2700
Check out resources Dike Drummond MD www.thehappymd.com does coaching with providers free book and articles
1. Depersonalization 2. Emotional exhaustion 3. Loss of sense of accomplishment
1. Vacations don’t usually help Burnout. 2. Burnout occurs in work life. 3. Burnout causes an erosion of the soul.
Areas to make energy deposits into *restore passion for medicine *self care to feel good *mindfulness *meditation *movement *nutrition
Mentor coaching Weekly CBT
Pam Laubscher DO Family Medicine and Osteopathic Manipulation Carondelet Medical Group, Bear’s Path Office Cell phone (520) 591-2533 Email – [email protected]