SAFE Opioid Prescribing Strategies. Assessment. Fundamentals. Education

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1 Educational Grant in Support of this CME Activity SAFE Opioid Prescribing Strategies. Assessment. Fundamentals. Education Extended Release and Long Acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) This educational activity is supported by an independent educational grant from the Extended Release/Long Acting Opioid Analgesic REMS Program Companies. Please see la opioidrems.com/iwgceui/rems/pdf/list_of_rpc_companies.pdf for a listing of REMS Program Companies. This activity is intended to be fully compliant with the Extended Release/Long Acting Opioid Analgesics REMS education requirements issued by the US Food & Drug Administration. 5 7 Overall Program Learning Objectives Modules I VI Upon completion of this activity, the participants will be better able to: Implement patient assessment strategies, including tools to assess risk of abuse, misuse, or addiction when prescribing extended release and long acting (ER/LA) opioids Employ approaches to mitigate risks when initiating therapy, modifying dose, and discontinuing ER/LA opioids Monitor patients by evaluating treatment goals and implementing periodic urine drug testing (UDT) Employ patient education strategies to reduce the risks associated with the use of ER/LA opioids Identify similarities and differences among ER/LA opioids 8 Background: The Prevalence of Chronic Pain in the United States Is High Approximately 100 million US adults experience chronic pain (%) 25. million US adults report daily (chronic) pain; 2. million report a lot of pain Numerous studies indicate undertreated pain: eg, cancer, older adults, children, minorities Low back pain, neck pain, and osteoarthritis are among the 9 leading causes of disability Low back pain is the leading cause of years lived with disability in the United States and accounts for one-third of all work loss IOM (Institute of Medicine) Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: The National Academies Press; University of Wisconsin Madison. Pain & Policy Studies Group. Accessed January 17, 2018; Nahin RL. J Pain. 2015;16(8): ; Kroenke K, Cheville A. JAMA. 2017;17(2):

2 Background: Non Opioid Analgesic Options Are Limited Background: Opioids for Chronic Pain Acetaminophen minimal efficacy in LBP, small efficacy in OA; hepatotoxicity may occur at doses >000 mg/d NSAIDs small efficacy in LBP; FDA warning of risk for heart attack and stroke as early as the first weeks of use; GI toxicity Gabapentinoids and SNRIs indicated for neuropathic pain. Efficacy for LBP and other musculoskeletal disorders uncertain Tricyclic antidepressants and muscle relaxants relatively weak evidence base for chronic pain Opioids may be a viable option for pain refractory to other treatments Recent guidelines (CDC) recognize that judicious prescribing and monitoring is appropriate for selected patients Placebo controlled trials demonstrate modest efficacy Paucity of evidence for long term effectiveness true for all analgesics, not just opioids Goal: define most appropriate analgesic regimen for each person in pain, which may include the use of opioids (IR and ER/LA) LBP, low back pain; FDA, US Food and Drug Administration; GI, gastrointestinal; NSAIDs, nonsteroidal anti-inflammatory drugs; OA, osteoarthritis; SNRIs, serotonin norepinephrine reuptake inhibitors. EnthovenWT et al. Cochrane Database Syst Rev. 2016;2:CDO12087; Kroenke K, Cheville A. JAMA. 2017;17(2): IR, immediate release. Ensure availability of opioids for patients with pain Kroenke K, Cheville A. JAMA. 2017;17(2): AND Establish systems of control to prevent abuse 11 Background: Opioid Abuse and Overdoses In 2016: 91.8 million US adults used prescription opioids 11.8 million misused prescription opioids 2.1 million with opioid use disorder (OUD) The most commonly reported motivation for misuse was to relieve physical pain (6.%) Misuse and use disorders most common in uninsured, unemployed, low income, behavioral health problems In 2015:,091 persons died from drug overdoses involving opioids (Rx and illegal) 15,281 persons died from drug overdoses involving Rx opioids >0% of drug overdose deaths also included benzodiazepines NSDUH Improper use of any opioid can result in serious side effects, including overdose and death. This risk can be greater with ER/LA opioids. 12 Centers for Disease Control and Prevention. National Center for Health Statistics. Multiple Cause of Death on CDC WONDER Online Database, released Accessed January 11, 2018; Prescription Drug Monitoring Program Training and Technical Assistance Center. Waltham, MA: The Heller School for Social Policy and Management, Brandeis University. 1

3 Statistically Significant Changes in Drug Overdose Death Rates Involving Natural and Semi synthetic Opioids by Select States, United States, Classifying Pain Acute Pain results from disease, inflammation, or injury to tissues Comes on suddenly, eg, post surgery or trauma The pain is self limiting confined to a given period of time and severity Acute pain can become chronic Chronic pain is considered a chronic disease condition Can be made worse by environmental and psychological factors Persists over time and is resistant to many medical treatments Those with chronic pain may suffer from more than 1 painful condition Common mechanisms may put some at higher risk to develop multiple pain disorders Centers for Disease Control and Prevention. Injury Prevention & Control: Opioid Overdose; Prescription Opioid Overdose Data (Natural and Semi- Synthetic Map). Accessed January 11, NIH. National Institute of Neurological Disorders and Stroke. Pain: Hope through research. Caregiver-Education/Hope-Through-Research/Pain-Hope-Through-Research#08_. Accessed November 29, Classifying Pain Nociceptive pain may be thermal, chemical, or mechanical In response to noxious stimuli, a message is transmitted via the primary afferent nociceptor axon from the periphery to the central nervous system (CNS) Neuropathic pain results from injury to nerves in the peripheral or central nervous systems It can occur in any part of the body and may result from diseases that affect the nerves, such as diabetes; from trauma; or as the consequence of chemotherapy for cancer Often described as a hot, burning sensation Neuropathic pain syndromes include diabetic neuropathy, complex regional pain syndrome, phantom limb, postherpetic neuralgia, and central pain syndrome Goals of Risk Evaluation and Mitigation Strategy (REMS) CME on ER/LA Opioid Analgesics In 2012, the FDA directed all ER/LA opioid companies to provide independent CME grants to educate prescribers and to provide information for patients to: Ensure that the benefits of ER/LA opioids outweigh the risks Help to reduce risk for ER/LA opioid analgesics misuse, abuse, and overdose while ensuring access to pain medication Follow FDA Blueprint on ER/LA opioids CME to engage and educate prescribers and be in compliance with standards for continuing education for physicians and other health care professionals, including Accreditation Council for Continuing Medical Education (ACCME) Institute of Medicine (US) Committee on Pain, Disability, and Chronic Illness Behavior; Osterweis M et al, eds. Pain and Disability: Clinical, Behavioral, and Public Policy Perspective. Washington (DC): National Academies Press (US); 1987; NIH. National Institute of Neurological Disorders and Stroke. Pain: Hope through research. Research/Pain-Hope-Through-Research#08_. Accessed November 29, This 6-Module Activity Is FDA REMS-Compliant CME CME, continuing medical education. Updated May Accessed January 17,

4 Goals of This REMS Compliant Education for ER/LA Opioid Analgesics As clinicians, WE are best positioned to balance treatment of pain against risks of serious adverse outcomes, including addiction, unintentional overdose, and death In this 6 module curriculum, we will review many best practice aspects of managing ER/LA opioid analgesic therapy Patient assessment Therapy initiation, dose modification, and discontinuation Therapy management Counseling of patients and caregivers General drug information Product specific drug information Evaluation is Essential for Safe and Effective Pain Management Using ER/LA Opioids Updated May Accessed January 17, Opioid Therapy in Chronic Pain Management Opioids ARE commonly prescribed for chronic pain Efficacious for many types of pain, though not necessarily for all people who experience pain Appropriate use is KEY to safety and success Goals of chronic opioid therapy: Improve and/or stabilize pain intensity Improve function Improve quality of life (QOL) However, significant gaps exist between guideline recommendations for safe prescribing practices of ER/LA opioids and how they are being used in practice Highlights need for further education Opioid Therapy Good Pain Management Principles Evidence based Multidimensional Based on appropriate assessment A dynamic process But there are also risks to consider McCarberg BH. Postgrad Med. 2011;12(2):

5 Risks Associated With ER/LA Opioids Overdose Life threatening respiratory depression Abuse by patient or household contacts Misuse and addiction Physical dependence and tolerance Interactions with other medications and substances Risk of neonatal opioid withdrawal syndrome with prolonged use during pregnancy Inadvertent exposure by household contacts, especially children Term Tolerance Physical Dependence Addiction Key Concepts Definition State of adaptation. Exposure to a drug induces changes that result in a diminution of 1 or more of the drug s effects over time. Indicated by a need for increasing doses to achieve the same effect. Occurs with opioids. Tolerance is not indicative of addiction. State of adaptation manifested by drug class specific withdrawal syndrome that can occur with abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Physical dependence occurs in all patients using opioids for a period of time. Physical dependence is not indicative of addiction. A primary, chronic, neurobiologic disease with genetic, psychosocial, and environmental components. Characteristic behaviors include 1 or more of the following: impaired control over drug use, compulsive use, continued use despite harm, craving. Updated May Accessed January 17, Savage SR et al. J Pain Symptom Manage. 200;26(1): ; Jamison RN et al. Clin Neuropsychol. 201;27(1): Tolerance, Dependence, and Addiction Critical Differences Tolerance, Dependence, and Addiction Critical Differences What a patient who has developed tolerance to the analgesic effect of the prescribed opioid would say to you: The fentanyl patch that you prescribed used to work really well, and now it doesn t seem to be easing as much of the pain as before. I am worried. Behavior that the addicted patient may display: My husband used his entire month s supply of that extendedrelease opioid you gave him in 1 week. He seems like a totally different person. I am very concerned. What a patient who has become physically dependent will typically say to you: I went up to the lake this weekend and forgot to take along my long acting morphine. I was without it for 2 days. I got so sick that I went to the ER. 29 0

6 Key Concepts Who Misuses/Abuses Opioids and Why? Term Definition Abuse Misuse Aberrant Drug Related Behavior Any use of an illegal drug, or the intentional self administration of a medication for a nonmedical purpose, such as altering one s state of consciousness for example, getting high. Use of a medication (for a medical purpose) other than as directed or as indicated, whether willful or unintentional, and whether harm results or not. A behavior outside the boundaries of the agreed on treatment plan. Nonmedical Use Recreational abusers Patients with disease of addiction Medical Use Pain patients seeking more pain relief Pain patients escaping emotional pain Chou R et al. J Pain. 2009;10(2): Examples of Misuse and Abuse Prescribers Can Play an Active Role in Reducing the Risks Associated With Opioids What patients will typically say to you: Sometimes in the morning I need to take extra pills just to get going Establish diagnosis History and physical Relevant diagnostic tests My friend was visiting this weekend and had terrible back pain. I gave her one of my oxycodone pills. It really helped her. That s OK, right? When opioids are being considered as part of acute or chronic pain treatment plan, complete an appropriate risk assessment This is an active and ongoing process That hydrocodone you gave my wife well, it seems to make her feel a little too good sometimes. I think she s taking more than you ve prescribed and I m worried about it McCarberg BH. Postgrad Med. 2011;12(2):119-10; Brennan MJ, Stanos S. PM R. 2010;2(6):5-558.

7 Risk Factors for Opioid Related Aberrant Behaviors Risk Stratification and Monitoring Tools Family and/or personal history of substance abuse Alcohol, illegal drugs, prescription drugs Prescription drug abuse history carries greater risk Age 16 to 5 years History of preadolescent sexual abuse Increases risk for women Psychological disease Attention deficit disorder (ADD) or depression ADD carries higher risk A history of substance abuse does not preclude treatment with ER/LA Use opioids of Risk Stratification but may require Tools and additional Ongoing Monitoring monitoring KEY to and Safe expert and Effective consultation Opioid Use Risk Stratification Tool (used before opioids are prescribed) Screener and Opioid Assessment for Patients with Pain (SOAPP) Opioid Risk Tool (ORT) Available iles/opioidrisktool.pdf Webster LR et al. Pain Med. 2005;6(6): Family History of Substance Abuse Opioid Risk Tool (ORT) Category Risk Factor Score if Female Score if Male Personal History of Substance Abuse Alcohol Illegal Drugs Prescription Drugs Alcohol Illegal Drugs Prescription Drugs Age Age 16 5 years 1 1 History of Preadolescent Sexual Abuse 0 Psychological Disease ADD, OCD, Bipolar Disorder, Schizophrenia Depression Total Score Risk Category Low Risk 0 Moderate Risk 7 High Risk SOAPP Sample Questions Please answer the questions below, using the following scale: 0 = Never, 1 = Seldom, 2 = Sometimes, = Often, = Very Often 1. How often do you have mood swings? How often do you smoke a cigarette within an hour after you wake up? How often have you taken medication other than the way that it was prescribed? How often have you used illegal drugs (for example, marijuana, cocaine, etc) in the past five years? 5. How often, in your lifetime, have you had legal problems or been arrested? OCD, obsessive compulsive disorder. Webster LR et al. Pain Med. 2005;6(6): Accessed January 17, Reprinted with permission: Lynn Webster, MD. 7 8

8 Stratify Risk Low Risk Moderate Risk High Risk No past/current history of History of treated Active substance abuse substance abuse substance abuse Active addiction Noncontributory family Significant family history history of substance abuse of substance abuse Major untreated psychological disorder No major or untreated Past/Comorbid psychological disorder psychological disorder Significant risk to self and practitioner Consider referring high risk patients or any patient you have concerns about to a pain specialist Webster LR, et al. Pain Med. 2005;6(6): Case Peter 5 year old white male, railroad worker for line maintenance and reconstruction S/p lumbar fusion with chronic back and leg pain Hx of back pain prior to injury that led to surgery, otherwise healthy Still experiencing pain despite multiple treatments described below History Injured at work; pain on lower right side, radiating down right leg to outside of foot Pain described as aching and throbbing Pain severity 6/10 at rest and 7 9/10 when bending, coughing, or straining with a bowel movement NSAIDs, muscle relaxant, and light work duty attempted Patient struggled on job; complaints of severe pain 0 Peter History (cont) Physical therapy (PT), X ray, MRI (L5 S1 disc w impingement of S1 nerve root) Failed steroid taper, hydrocodone, epidural steroid, more PT Sleep deprived, anxious, withdrawn, financially stressed Surgery and rehabilitation no improvement Pain specialist prescribed: Oxycodone CR tablets 0 mg every 12 hours Hydrocodone/acetaminophen 5/00 8/d for breakthrough pain Gabapentin 00 mg/ 2 tablets TID Zolpidem 10 mg/hs Returns to your office for ongoing pain management Next Steps: Make No Assumptions Even though the prescriber of the CR oxycodone and hydrocodone/acetaminophen has evaluated Peter s risk for opioid misuse before initiating these drugs, should you re assess his level of risk now that the patient is back in your care? Yes, because the risk level can change and you want to document that you have performed a risk assessment CR, controlled-release; MRI, magnetic resonance imaging. 1 2

9 Family History of Substance Abuse Peter s Score on ORT Category Risk Factor Score if Female Score if Male Personal History of Substance Abuse Alcohol Illegal Drugs Prescription Drugs Alcohol Illegal Drugs Prescription Drugs Age Age 16 5 years 1 1 History of Preadolescent Sexual Abuse 0 Psychological Disease ADD, OCD, Bipolar Disorder, Schizophrenia Depression Total Risk Score Total Score Risk Category Low Risk 0 Moderate Risk 7 High Risk 8 Webster LR et al. Pain Med. 2005;6(6):2-2. Opioid Risk Tool. Accessed January 17, Reprinted with permission: Lynn Webster, MD Peter Next Steps: Make No Assumptions Complete history and physical establish diagnosis Ask Peter about his goals for treatment: Explain that complete pain relief is rarely achieved Focus on functional goals, eg, return to work, work part time, able to play golf on weekends, able to walk the dog daily Risk for aberrant drug behavior Moderate ( on ORT) Evaluate mental health status Peter s Rx: oxycodone CR, hydrocodone/apap, gabapentin, zolpidem any other Rx? OTC? Drug drug interactions? Re establish care with new treatment agreement and UDT Peter s household What is the possibility of inadvertent exposure to the opioids you are prescribing by household contacts, especially children? Have you discussed safe storage? Opioid Therapy Ongoing Monitoring Additional Tools for Ongoing Monitoring ANALGESIA The A s ADVERSE EFFECTS Pain Assessment and Documentation Tool (PADT) Sample Questions Is the patient s functioning with the current pain reliever(s) better, the same, or worse since last assessment? Is patient experiencing any side effects from current pain reliever(s)? Check list of potential aberrant drug related behavior Available at ACTIVITIES OF DAILY LIVING ABERRANT DRUG TAKING BEHAVIORS Important to remember two other A s : Assessment and Action (treatment plan) Current Opioid Misuse Measure (COMM) Sample Questions In the past 0 days, how often have you taken your medications differently than how they are prescribed? In the past 0 days, how much of your time was spent thinking about opioid medications (having enough, taking them, dosing schedule, etc)? In the past 0 days, how often have you had to visit the emergency room? Available at Passik SD et al. Adv Ther. 2000;17(2):

10 Talk to Me: Proven Methods to Counsel Your Patients on ER/LA Opioids and Achieve Positive Outcomes Patient Counseling Document 9 ER/LA Analgesics REMS. Accessed November 29, Counseling Patients and Caregivers About ER/LA Opioids Counseling Patients and Caregivers Use Patient Counseling Document for ER/LA opioids to: Explain product specific information Explain how to take and importance of adherence Tell patient and/or caregiver they will receive a Medication Guide from the dispensing pharmacy Stress importance of reading the Guide and getting answers to any questions they may have from the pharmacist or you Warn patients about dangers of tampering with ER/LA opioids Caution patients about use of other CNS depressants, including alcohol Instruct patients to tell you about all medications they are taking Warn patients to never abruptly discontinue their ER/LA opioid Caution patients about all adverse effects Specifically about signs and symptoms of respiratory depression, gastrointestinal obstruction, and allergic reactions Instruct them on when and how to call you about side effects they experience so that you can work with them to manage Instruct them to call 911 if they have trouble breathing or experience shortness of breath Caution patients to never share their ER/LA opioid with ANYONE Counsel patients about the risk of falls, working with heavy machinery, and driving Advise patients to store their medication carefully and dispose of safely when no longer needed Medication Guides typically include specific disposal information Updated May Accessed January 17, Updated May Accessed January 17,

11 Patient Education and Counseling Works! Why is patient and caregiver education so important? Utah Department of Health statewide program demonstrated effectiveness of patient education to reduce unintentional deaths from prescription opioids Media campaign Use Only As Directed from May 2008 to May 2009, including: Television and radio spots Distribution of opioid prescribing guidelines and copies of print materials (bookmarks, patient information cards, educational posters) Results: In , 1% decrease in unintentional overdose deaths from prescription opioids compared with Johnson EM et al. Pain Med. 2011;12 suppl 2:S66-S How to Counsel Patients to Use Exactly as Prescribed THE DOs Tell your patients: Read Medication Guide from dispensing pharmacy Take your medicine exactly as prescribed Call your prescriber if your pain is not controlled Store your medicine away from children and in a safe place Flush unused medicine down the toilet Call your health care provider for medical advice about side effects. You may report side effects to the FDA at FDA 1088 or via 9.pdf Seek emergency treatment if an opioid overdose occurs How to Counsel Patients to Use Exactly as Prescribed THE DON Ts Tell your patients: Do not give your medicine to others Do not take medicine unless it was prescribed for you Do not stop taking your medicine without talking to your health care provider Do not break, chew, crush, dissolve, or inject your medicine. If you cannot swallow your medicine whole, talk to your health care provider Do not cut, tear, or damage buccal film or dermal patches as this may lead to rapid release of ER/LA opioid and result in overdose and death Do not drink alcohol while taking this medicine Updated May Accessed January 17, Updated May Accessed January 17,

12 Patient Counseling Document Case Joan PCD should be provided to and reviewed with patient and/or the caregiver at time of prescribing PCD is available free of charge at la opioidrems.com/iwgui/rems/pcd.action 62 year old female with severe right hip osteoarthritis Has significant medical issues that prevent her from undergoing total hip replacement Started physical therapy, but stopped because of increase in pain Her pain is significantly affecting her quality of life Unable to take NSAIDs because of previous GI bleed Her PCP initiated a trial of Ultram (tramadol), 50 mg, 1 2 tid, with no reported analgesia This was followed by a 2 week course of Nucynta (tapentadol), 50 mg, 1 PO Q 6 h Reported pain relief for only hours, with VRS pain intensity decreasing from 8 to 5/10 Because of less than optimal duration of effect, PCP decides to initiate a trial of Nucynta ER (tapentadol ER), 100 mg PO Q 12 h ER/LA Analgesics REMS. Accessed November 29, PCP, primary care physician; VRS, verbal rating scale. 61 Ensure Patients Know to Take Opioids ONLY As Prescribed Patients Need to Know About Adherence to Prescribed Opioid Regimen Instructions need to be product specific: For instance, because Joan is taking Nucynta ER (tapentadol ER); she should be advised to: Not crush or chew her medication Place tablet in mouth and take it with enough water to ensure complete swallowing immediately afterward Take a dose every 12 hours at same time every day But, if you had prescribed Kadian (morphine sulfate) to Joan, you would advise her to: Swallow capsule intact (whole); never to crush, dissolve, or chew the pellets If she cannot swallow the capsule whole, contents of the Kadian capsule (pellets) can be sprinkled on applesauce and then swallowed without chewing 62 Counsel patients and caregivers ER/LA opioid medication and dosage is based on their individual needs Doubling up on a dose or taking it sooner than prescribed risks overdose with possible life threatening consequences Taking more than prescribed constitutes misuse or abuse Missing a dose may result in inadequate pain relief What to do if a dose is missed Updated May Accessed January 17,

13 Explain the Dangers of Combining Opioids With Other Substances Discuss the Dangers of Abruptly Discontinuing Medication Caution patients and caregivers that overdose or death can occur if ER/LA opioids are used with other CNS depressants, including: Sedative hypnotics: eg, zolpidem (Ambien); triazolam (Halcion); temazepam (Restoril) Anxiolytics: eg, diazepam, clonazepam Illegal drugs: eg, heroin Fatal opioid poisonings have been associated more often with concomitant use of benzodiazepines or alcohol Advise patients to use other CNS depressants, including other opioids, only under instruction of their prescriber Advise patients to tell all their health care providers about all medications they are taking Warn patients to not abruptly discontinue or reduce their ER/LA opioid analgesic and to discuss with you, the opioid prescriber, how to safely taper the dose if they wish to discontinue Abruptly discontinuing an opioid may lead to withdrawal syndrome Stomach cramps, diarrhea, rhinorrhea, sweating, elevated heart rate, increased blood pressure, irritability, dysphoria, hyperalgesia, insomnia Updated May Accessed January 17, Updated May Accessed January 17, 2018; Morgan MM, Christie MJ. Br J Pharmacol. 2011;16(): Inform Patients of Seriousness of Adverse Events Associated With Opioids Opioid Overdose Caution patients and caregivers that opioids can cause serious side effects that may lead to death Discuss: Signs and symptoms of an overdose, such as lethargy and somnolence, cognitive impairment Opioid induced respiratory depression Risk for severe constipation and gastrointestinal obstruction Emphasize the importance of healthy bowel habits: keeping hydrated, less sedentary Possibility of allergic reactions Fatal overdose is not instantaneous there is usually time for remedial action Naloxone can quickly reverse the effects Both patients and caregivers need to know how to identify opioid overdose, because signs of an overdose are often missed Opioid overdose signs include: Mental depression Hypoventilation (decreased respiration) Reduced bowel motility Miosis (contracted pupils) Updated May Accessed January 17, Green TR et al. Addiction. 2008;10(6): ; Williams RH et al. Laboratory Med. 2000;1:-2. 67

14 Update on Joan Joan returns to office after 1 month Reports better pain relief and improved quality of life Tolerating Nucynta ER (tapentadol ER) 100 mg bid and oxycodone 5 mg, 1 2 per day for breakthrough pain Urine drug toxicology testing (UDT) is completed She reports running out 2 days early and is requesting early refill She states: My daughter hurt her back, so I gave her a couple of my pills. It helped her pain, too. What should you do? Dangers of Sharing Medication: Legal Responsibilities of the Patient In our society, a commonly held belief among patients and caregivers is that sharing prescription medications is not dangerous or a problem because prescription medications are safe Here s what you should do: Counsel Joan about importance of not giving her medication to or sharing it with others, even her daughter Advise her that drugs prescribed for one patient can have serious or even fatal consequences for another Tell her that sharing or selling prescription medications is illegal 68 Manchikanti L et al. Pain Physician. 2012;15( suppl):s67-s116; SAMHSA (2010) National Survey on Drug Use and Health. Accessed November 29, Storing ER/LA Opioids Safely Disposing of ER/LA Opioids Patients and caregivers must understand importance of storing opioids carefully and protecting them from theft A secure place away from children, family members, household visitors, and pets eg, a medication safe, which not only deters theft, but also inadvertent use in children, which could be fatal Counsel patients to dispose of any ER/LA opioid analgesics that are no longer needed Encourage them to read product specific disposal information, including the Medication Guide Manchikanti L et al. Pain Physician. 2012;15( suppl):s67-s116; SAMHSA (2010) National Survey on Drug Use and Health. Accessed November 29, Updated May Accessed January 17, 2018; Practical Pain Management. Opioid Disposal: Dos and Don ts. Accessed November 28,

15 Safe Disposal of Unused Medications To Flush or Not to Flush? Disposal of unused medications In household trash By flushing Know state laws May vary according to formulation (ie, pills vs patches) Take back programs National Take Back Days Local programs 1. Mix medicines (do not crush) with unpalatable substances (kitty litter, coffee grounds) 2. Place in a container (plastic bag). Throw in household trash. Scratch out personal information, then dispose container FDA recommends flushing CERTAIN unused or expired medications BECAUSE THEY ARE DEEMED TOO DANGEROUS if take back programs not available (see following slides) Impact on environment and human health Most medicines flushed flush list of opioids Known risks outweigh harms to humans or the environment 72 Khan U et al. Sci Total Environ. 2017;609 : ; salofmedicines/ucm htm. 7 Drugs to Be Flushed FDA Recommendation Medicines Recommended for Disposal by Flushing Listed by Medicine and Active Ingredient There is a small number of medicines that may be especially harmful and, in some cases, fatal with just 1 dose if they are used by someone other than the person for whom the medicine was prescribed. This list from FDA tells you what expired, unwanted, or unused medicines you should flush down the sink or toilet to help prevent danger to people and pets in the home. This list includes all opioid formulations, both IR and ER/LA 7