Learning Objectives. Opioid Prescriptions in the US. The Opioid Epidemic

Transcription

1 The Opioid Epidemic Sarah J. Payne, MS, PharmD, BCPS Assistant Professor, UNT System College of Pharmacy Learning Objectives 1. Describe the prescription painkiller epidemic. 2. State the DEA Scheduling Class for hydrocodone as of October Opioid Prescriptions in the US 1

2 Opioid Use by Age Deaths from Opioid Painkillers What Can Be Done? Federal Government Support states development of programs and policies Supply healthcare providers with guidance Increase access to mental health services Reclassification of controlled substances Hydrocodone to CII 2

3 What Can Be Done? State Governments use of prescription drug monitoring & substance abuse treatment Create policy relating to use of pain medications Assess effectiveness of health programs What Can Be Done? Healthcare Providers Identify patients who might be misusing drugs Use effective treatments for substance abuse Discuss risks and benefits of pain treatment Follow best practices Screening for substance abuse and mental health problems Avoid combinations of painkillers and sedatives, if possible Prescribe lowest effective dose and specific quantity needed What Can Be Done? Everyone Avoid taking painkillers other than prescribed Dispose of medications properly Help prevent misuse and abuse Get help for substance abuse problems HELP 3

4 Jon C. Sivoravong, D.O. Associate Professor and Vice Chair for Clinical Affairs Department of Family Medicine-UNTHSC March 2015 Goals and objectives Understand acute and chronic pain Understand abuse, addiction and aberrant behaviors Describe the frame work for opioid prescription Able to locate Prescription Access in Texas website Able to write schedule II prescription Treatment of nonmalignant chronic pain in primary setting No issue more polarizing than management of chronic pain Spectrum of belief on treatment ranges from those who believe narcotics should never be prescribed who believe narcotics best therapeutic option 1:4 American suffers from chronic pain 4

5 Treatment of nonmalignant chronic pain in primary setting No issue more polarizing than management of chronic pain Spectrum of belief on treatment ranges from those who believe narcotics should never be prescribed who believe narcotics best therapeutic option 1:4 American suffers from chronic pain Three Main types of pain pathophysiology Nociceptive Pain RA, Gout, Osteoarthritis Neuropathic Pain Diabetic peripheral neuropathy, post herpetic neuralgia Sensory Hypersensitivity Fibromyalgia Three Main types of pain pathophysiology Nociceptive Pain RA, Gout, Osteoarthritis Neuropathic Pain Diabetic peripheral neuropathy, post herpetic neuralgia Sensory Hypersensitivity Fibromyalgia 5

6 Three Main types of pain pathophysiology Nociceptive Pain RA, Gout, Osteoarthritis Neuropathic Pain Diabetic peripheral neuropathy, post herpetic neuralgia Sensory Hypersensitivity Fibromyalgia Pain: Unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage does not require nociception, as pain is emotional experience. International Association for the Study of Pain (IASP) Pain: Unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage does not require nociception, as pain is emotional experience. International Association for the Study of Pain (IASP)

7 Short or appropriate duration (usually <2 wk.) Specific pathology Treatment obvious Acute pain Useful in getting person to physician Generally does not interfere with function Short or appropriate duration (usually <2 wk.) Specific pathology Treatment obvious Acute pain Useful in getting person to physician Generally does not interfere with function Chronic pain -70 million sufferer 2003 Persist longer than 3 or 6 month Persist longer beyond the normal healing process Occurs after acute injury or have no apparent cause May spread beyond the original site Appears to serve no biological purpose Moderate to severe intensity Limits physiologic function and Psychological and emotional activities Reduce quality of life Refractory to treatment. JAMA

8 Chronic pain -70 million sufferer 2003 Persist longer than 3 or 6 month Persist longer beyond the normal healing process Occurs after acute injury or have no apparent cause May spread beyond the original site Appears to serve no biological purpose Moderate to severe intensity Limits physiologic function and Psychological and emotional activities Reduce quality of life Refractory to treatment. JAMA 2003 Rights and Responsibilities of prescribers of Opioids Pain is usually undertreated due to multiple cause Decision to give opioids is difficult when patient is not an ideal candidate Prescriptions must be individualized (medical, psychiatric and hsx response) Prescriber may occasionally be misled by patients who divert or misuse Prescribers have obligation to understand the risks, and management of addictive disease. Prescribers who persistently fail to treat addiction is poor medical practice Prescribers who fail to prescribe opioids when use is indicated is also poor medical practice Providers traditionally receive little or no education about pain management or treatment of addition. American Academy of Pain Medicine 2004 Prescription drug abuse Most abused Opioids CNS depressant anxiety and sleep disorders Stimulants ADHD and Narcolepsy Young people 1 in 5 teenager Most popular drugs Hydrocodone 18% Oxycodone 10% ADHD drugs 10% National Institute of Drug Abuse Partnership for drug free America

9 Memory-Addiction- Reward Pathway (in a nutshell) VTA and NAC - reward pathway Dopamine Opioid receptors Frontal cortex and limbic system High Dopamine released- trigger High Glutamate release in memory pathway Hypermemory state - embedded in cortex Stress: fuel to the fire of addiction Stress causes individuals to search for solutions; in modern era, solutions often involve use of pharmacologic agents Common Clinical pathway: Patients with unclear pathology start on chronic pain pathway and see many physicians who offer different right answers but inadequate care this leads to anxiety and depression 45% of patients have depressed and anxiety disorder by time they see specialist in chronic pain Chronic pain research suggests primarily an emotional disorder Clinical Characteristics of chronic pain patients Verbalization: pain becomes patient s life Populations at risk: women 40 to 49 yr. of age Depression: can prevent patient s ability to discriminate pain level assessment questionnaires (e.g., Beck Depression Inventory) Hostility: clinician must set boundaries on hostile behaviors Manipulative: centered on obtaining narcotics Drug abuse: usually not patients intent 9

10 Drug abuse The use of any substance for nontherapeutic purpose or the use of medication for purposes other than those for which the agent is prescribed. Drug abuse The use of any substance for nontherapeutic purpose or the use of medication for purposes other than those for which the agent is prescribed. Addiction A primary chronic neurobiological disease influenced by genetics, psychosocial, and environmental factors. It is characterize by impaired control over drug use, compulsive drug use, and continued drug use despite harm and because of craving. 10

11 Addiction A primary chronic neurobiological disease influenced by genetics, psychosocial, and environmental factors. It is characterize by impaired control over drug use, compulsive drug use, and continued drug use despite harm and because of craving. Abuse vs Addiction: Abuser Stressors influential in Abusers Abusers or heavy abusers behave as if addicted when under severe stress Addiction Behavior uncontrolled without means of modulation Substance escalate steadily under normal circumstances in absence of stress Eventually, substance becomes solution to every form of emotional discomfort Chronic pain Medication use not out of control Medication improve quality of life Is concerned about physical problem Follow agreement for opioids Frequently has leftover Chronic pain patient vs Addicted patient Addicted Out of control Medication diminished quality of life Increase medication use despite adverse effects Unaware of or denial about problem as a result from drug treatment Does not follow agreement Does not have leftover, loses prescriptions, always has a story 11

12 Aberrant Behavior, Abuse and Addiction Chronic pain pt. Addiction 2-5% Abuser 20% Aberrant Behavior 40% All addicted people are abusers, but not all abusers are addicted Webster, Pain Med Aberrant Behavior, Abuse and Addiction Chronic pain pt. Addiction 2-5% Abuser 20% Aberrant Behavior 40% All addicted people are abusers, but not all abusers are addicted Webster, Pain Med Differential for aberrant behavior Addiction Pseudoaddiction Other psychiatric disorder Anxiety, major depression Personality disorders, antisocial Encephalopathy Psychosocial or emotional issues Recreational 12

13 Aberrant behavior classification Relative severity - egregious Quantity - multiple Persistence - recurrence Purpose - deliberate misuse Time consuming nature - health care resource Behaviors predictive of addiction Lesser Aggressive complaining for higher dose Drug hoarding Request specific drugs Multiple prescriber Unsanctioned dose escalation 1-2x Unapproved use of drug to treat another symptom Reporting psychiatric drug related effects Occasional impairment More Selling prescription drugs Forgery Stealing Injecting oral formulation Obtaining drugs from nonmedical source Multiple prescription loss Concurrent abuse of related illegal drugs Multiple dose escalations despite warning Repeat episodes of gross impairment Portenoy. J Pain Symptoms Management 1996 Expert 5 point checklist for drug abuse 1. Overwhelming time spend on opiates discussion after a 3 rd visit. 2. Pattern of early refill (3 or more) or dose escalation. 3. Multiple phone calls to the office. 4. Pattern of lost, spilled or stolen prescriptions. 5. Multiple source of opiates. Webster, Avoiding Opioid Abuse while managing pain. Sunrise river press

14 Documentations Careful observation and documentation of drug aberrant behavior should be charted in chronic pain patients like any clinical data such as hemoglobin A1c in diabetic patients and blood pressure reading on hypertensive patients. A Framework for Appropriate Opioid prescribing Narcotic prescription needs to be highly structured policy Specific guidelines Pain contract, UDS, refills, multidisciplinary team approach 1: Assess Risk - consider non opioids first Assess patient s risk for aberrant behaviors Assess the patient for psychological disorders Review your state s prescription monitoring program Conduct a baseline urine drug test 2: Select Agent Consider the patient s general condition, medical status, and prior opioid experience After deciding on an agent, consider an abuse-deterrent opioid 3: Dialogue with patient Discuss treatment expectations Review written treatment agreement 4: Monitor Treatment Regularly assess the 4 A s Analgesia: Activity: Adverse effects: Aberrant behavior: Risk Tools Addiction severity index Self or interview 200 item 1hr Alcohol use Disorder identification Test Self or interview 10 item 2 minutes Structure interview DSM-IV interview min CAGE interview 4 item <1 min Case Adapted to include drugs interview 4 items <1 min Two item conjoint screening tool interview 2 items <1 min Screener and Opioid Assessment for Patients with Pain (SOAPP) Self or interview 24 items 10 min Prescription Drug use Questionnaire interview 42 items 20 min RAFFT Self 5 items about 1 min Drug Abuse Screening Test self 20 items 5 min Michigan Alcohol Screening Test Self or interview 25 items 15 min Screening Instrument for interview 5 Items about 1 min Substance Abuse Potential Substance abuse Subtle self 1 page 15 min Screening Inventory Severity of opiate Dependence self 21 items about 5 min Questionnaire Opioid Risk Tool self 5 items 1 min 14

15 Webster LR, Webster R. Predicting aberrant behaviors in Opioid-treated patients: preliminary validation of the Opioid risk tools. Pain Med. 2005; 6(6): 432 Prescription Access in Texas (PAT) Authorized users can search the last 365-days worth of prescription dispensing history for Schedule II V controlled substances, 24-hours a day, seven-days a week, including patient prescription history and physician s own prescribing information. PAT is a secured, online prescription monitoring program Texas Department of Public Safety Hydrocodone Combination Products (HCPs) have been moved from Schedule III controlled substances to the more-restrictive Schedule II, effective on Oct. 6, The U.S. Drug Enforcement Administration s rescheduling of HCPs as Schedule II Controlled Substances will increase the restrictions on prescribing and dispensing practices for HCPs. 15

16 Each official prescription form or electronic prescription used to prescribe a Schedule II controlled substance must contain: (A) the date the prescription is issued (B) the controlled substance prescribed (C) the quantity of controlled substance prescribed, shown: (i) numerically, followed by the number written as a word (ii) numerically, if the prescription is electronic; (D) the intended use - the diagnosis (E) the practitioner's name, address, and DEA number (F) the name, address, and date of birth or age of the person (G) if the prescription is issued to be filled at a later date under (d-1), the earliest date on which a pharmacy may fill the prescription; (f) Not more than one prescription may be recorded on an official prescription form, except as provided by rule adopted under Dilemmas in treatment of Chronic nonmalignant pain: Lack appreciation between acute and chronic Use extended-release opioids (immediate-release agents may act as trigger) Emotional pain even in breakthrough pain Patients must stop chasing their pain Need to minimize effects on dopaminergic pathway Opioid limits: keep patients below high-dose level mg of morphine equivalents per 24-hr period * <60 mg recommended if possible Rotate long-term opioid use, agents and lower dose *Dunn KM, et. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med 2010;152(2):

17 Tolerance A physiologic state caused by regular use of an opioid in which increased doses are needed to maintain the same effect. In patients with analgesic tolerance, increased doses of the opioid are needed to maintain pain relief Physical Dependence A physiologic state characterized by abstinence syndrome (withdrawal) if treatment with an opioid is stopped or decreased abruptly or an opioid antagonist is administered. It is an expected result of opioid therapy and does not by itself equal addiction Abstinence Syndrome A syndrome characterized by symptoms that include sweating, tremor, vomiting, anxiety, insomnia, and muscle pain. caused by reduction in the opioid dose or opioid antagnonist. It can be avoided by carefully tapering the opioids dosage and monitoring the patient. American Academy of pain medicine American pain Society American society of addiction medicine 17

18 Rush Limbaugh Arrested On Drug Charges April 28, 2006 Prosecutors' three-year investigation of Limbaugh began after he publicly acknowledged being addicted to pain medication and entered a rehabilitation program. They accused Limbaugh of "doctor shopping," or illegally deceiving multiple doctors to receive overlapping prescriptions, after learning that he received about 2,000 painkillers, prescribed by four doctors in six months, at a pharmacy near his Palm Beach mansion. Limbaugh, who pleaded not guilty Friday, has steadfastly denied doctor shopping. Black said the charge will be dismissed in 18 months if Limbaugh complies with court guidelines. Mid Level, E-Prescribing, exceptions Senate Bill 406, effective Nov. 1, 2013, allows Mid-Level Practitioners to add Schedule 2 and 2N. E-prescribing capability for Schedule II prescriptions was implemented October Texas Administrative Code Exceptions to Use of Form. (a) An official prescription form is not required for a medication order written for a patient who is admitted to a hospital at the time the medication order is written and filled. (1) A practitioner may dispense or cause to be dispensed a Schedule II controlled substance to a patient who: (A) is admitted to the hospital; and (B) will require an emergency quantity of a controlled substance upon release from the hospital. Guidelines and templates American Pain Society/American Academy of Pain Medicine Department of Veterans Affairs/Department of Defense pdf Federation of State Medical Boards Utah Department of Health Washington State Agency Medical Directors Group

19 Pain Management in Oncology CHRISTOPHER JORDAN, DO, FACOI MARCH 18, 2015 UNTHSC GRAND ROUNDS Identifying Pain There are many tools useful for identifying patients with cancer-related pain Verbal Patient Literate Illiterate Non-verbal Patient Dementia ICU patient Anticipating Pain Pre-Procedural pain is expected in many different procedures in Oncology, (bone marrow aspiration and biopsies, radiation, mediport placement and/or access, wound care, line placement, port access, LP, skin biopsies, etc ) as well as other maneuvers, such as transportation Sufficient time and discussion with patients and family are important to plan analgesics (topical, local, and/or systemic therapy) as well as anxiolytic therapy 19

20 Pain Assessment There are many different factors involved in assessment of pain, and each one is helpful to identifying the best possible treatment of pain -cancer itself -treatment and/or procedures -coincidental (arthritis, etc ) Pathophysiology nociceptive, neuropathic, visceral, effective, behavioral, cognitive The Pain Experience Location, referral pattern, and pain radiation Intensity last 24 hrs and current (rest, movement) Interference with activities** Timing Description or quality of pain Aggrevating and alleviating factors Current treatment plan (both pharmacologic and non-pharmacologic) Response to current therapy The Pain Experience (cont) Breakthrough pain Prior pain therapies Special issues relating to pain family and patient understanding, meaning and consequences of pain, patient goals, cultural, spiritual and religious beliefs toward pain medications, potential for abuse/misuse 20

21 Pain Management First, its necessary to distinguish pain as an oncologic emergency or non-emergency Then, determination of pain medications is necessary based on patients being narcotic naïve or tolerant. Then, rating the pain 0-10 on numeric or picture scales, or using non-verbal pain scales, is necessary to establish severity of pain Pain management (cont) In patients experiencing pain <7 on 10 point scale, opiates should be a consideration up front, and adjuvant analgesics should be considered cautiously, as some can have adverse effects in both opiate naïve and opiate tolerant patients, though the dosages may differ significantly. Caution should be used in both so dangerous side effects (respiratory depression, etc ) can be avoided and titration should be rapid. Pain Management (cont) Once adequate pain control is achieved with short acting opioids, and the goal of therapy should be the highest level of pain control with the least amount of side effects, if pain is adequately controlled with short acting opioids, whether alone or in combination with other anagesics, then would keep patient on the current dosages 21

22 Pain Management (cont) If pain medication levels are adequate to achieve short term pain control, but are not sufficient for the prescribed period of time, then addition of longer acting medications is prudent here Long-acting medications should be prescribed to take around the clock and not prn and should not be used for the short term control of pain. Dosages should be equivalent to the shorter acting medications for the prescribed time periods of the shorter acting medications, though the length of action of longer acting medications will generally be longer (12-72 hours depending on medications) Breakthrough pain Defined as pain that develops between doses of medication, whatever the interval is. Generally, when patients have these levels of pain, they should be on long-acting medications and have short acting combination agents for short term, break through pain control Example: MS Contin Q12 hours ATC, followed by Norco Q4-6 hours prn breakthrough pain Breakthrough pain If breakthrough pain is severe and frequent, short acting pain medication is necessary and rapid titration of these medications are necessary to achieve short term pain control. Once these short acting doses are known, then increasing the dose of long acting medications would be appropriate 22

23 Other pain management options If pain is confined to one area, narcotic and nonnarcotic topical agents may be appropriate. These are beneficial because of local control with significantly less systemic effects. Limitations: not for generalized pain. Require compounding pharmacy expertise typically. Other pain management options (cont) Injections often, if pain is located in one area where a nerve block or local pain medications are appropriate, these can achieve very high levels of pain control (ex. Celiac plexus block in patients with pancreatic cancer) Pain pumps inserted to deliver continuous pain medication, typically to a specific nerve area to achieve adequate pain control Other pain management options (cont) Pain management consultation practitioners specializing in pain management can assist significantly in the management of pain in patients with cancer and should be considered when unable to adequately control pain with medication prescriptions Psychiatric consultation in patients with psychiatric disorders, such as depression, pain can be significantly exacerbated by the underlying condition and prescription of psychiatric medications as adjunct therapies should be considered. Also, patients without underlying conditions can certainly have depression secondary to their cancer diagnosis and this should ALWAYS be a consideration in pain management 23

24 Goal Regardless of pain site, and tolerance or naivety to opioids, the threshold for using opioid pain medication in patients with cancer should be low, as pain relief is the goal of therapy to keep patients from suffering and to remain active in their daily lives as much as possible. The best dose of pain medication is the dose that relieves the most pain but with the least amount of side effects of pain medication 24