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4 16 14 Suicide Poisoning Crude Rate per 100, Year Source: Rockett IR, Refier MD, Kapusta ND, et al. Leading causes of unintentional and intentional injury mortality: United States, American Journal of Public Health. September 20, 2012.

5 Number of Emergency Department Visits 400, , , , , , ,000 50,000 0 Narcotic Pain Relievers (PR) Muscle Relaxants 144,644 (PR) + 143,546 (B) + 25,934 + Benzodiazepines (B) Central Nervous System Stimulants Source: SAMHSA Drug Abuse Warning Network (DAWN), , ,931 50,878 9, , Year +Difference between this number of visits and the number of visits in 2009 is statistically significant at the.05 level

6 140, , % of admissions 132,763 Number of Admissions 100,000 80,000 60,000 40,000 20, , % of admissions Year Source: SAMHSA Treatment Episode Data Set (TEDS), 2009

7 Top 10 Prescribing Specialties Immediate-Release Opioids, 2009 Unspec.; 4.5% Anesthesiologists; 3.2% Physical Med & Rehab; 2.7% Orthopedist; 7.4% General Prac oners/ Family Medicine; 26.7% Other; 20.2% Internal Medicine; 15.4% Den sts; 7.7% Emergency Medicine; 4.7% Physicians Assistants; 4.0% Nurse Prac oners; 3.5%

8 Top 10 Prescribing Specialties Extended- Release/Long-Acting Opioids, 2009 Anesthesiologists; 13.8% Physical Med & Rehab; 9.3% Other; 11.8% General Prac oners/family Medicine; 27.0% Internal Medicine; 16.8% Unspec.; 4.9% Neurologist; 2.8% Orthopedist; 1.9% Hematology; 1.7% Physicians Assistants; 4.3% Nurse Prac oners; 5.7%

9 Percentage Swallow Chew Dermal Inhale Inject Trans Other Unknown *Respondents can indicate multiple options Source: Webster LR. Safe Opioid Prescribing: Reversing the Trends. Presented at: The 28 th Annual Mee ng of the American Academy of Pain Medicine; February 23 26, 2012; Palm Springs, CA.

10 70 60 Percentage *Respondents can indicate multiple options Source: Webster LR. Safe Opioid Prescribing: Reversing the Trends. Presented at: The 28 th Annual Meeting of the American Academy of Pain Medicine; February 23 26, 2012; Palm Springs, CA.

11 Safe Opioid Prescribing American College of Preven ve Medicine Webinar October 2012 Daniel P. Alford, MD, MPH, FACP, FASAM Associate Professor of Medicine Boston University School of Medicine Boston Medical Center

12 The Problem unrealis c expecta ons More UNREALISTIC expecta ons Opioids always = Pain relief therefore More opioids = More pain relief 2

13 Over- prescribing Medica on mania Hypertrophied enabling Confronta on phobia Under- prescribing Opiophobia Overes mate potency and dura on of ac on Fear of being scammed Exaggerated fear of addic on poten al Morgan, J. Adv Alcohol Subst Abuse, 1985 Smith DE, Seymore RB. Proc White House Conf on Prescription Drug Abuse,1980 Parran T. Medical Clinics of North America 1997

14 Issues Preven ng Opioid Prescribing n=111 Poten al for pa ents to become addicted 89% Poten al for pa ents to sell or divert 75% Opioid side effects 53% Regulatory/law enforcement monitoring 40% Hassle and me required to track/refill 28% Upshur CC et al. J Gen Intern Med 2006

15 What is Addic on? A clinical syndrome presen ng as Loss of Control Compulsive use Con nued use despite harm Aberrant Medica on Taking Behaviors (pa ern and severity) It is NOT physical dependence Biological adapta on with signs and symptoms of withdrawal (e.g., pain) if opioid is abruptly stopped Savage SR et al. J Pain Symptom Manage 2003

16 Aberrant Medica on Taking Behaviors The Spectrum of Severity o o o o o o o o o Requests for increase opioid dose Requests for specific opioid by name, brand name only Non- adherence w/ other recommended therapies (e.g., PT) Running out early (i.e., unsanc oned dose escala on) Resistance to change therapy despite AE (e.g. over- seda on) Deteriora on in func on at home and work Non- adherence w/ monitoring (e.g. pill counts, urine drug tests) Mul ple lost or stolen opioid prescrip ons Illegal ac vi es forging scripts, selling opioid prescrip on Modified from Portenoy RK. J Pain Symptom Manage 1996

17 Opioids Natural (opiates) & Semisynthetic Opiates Morphine Codeine Synthetic

18 Variable Response to Opioids Mu Receptor G protein- coupled receptor family, signal via second messenger (camp) Mu receptor subtypes >100 polymorphisms in the human MOR gene Opioid metabolism Differs by individual opioid and by individual pa ent Not all pain responds to same opioid in the same way Trial of several opioids may be needed to find acceptable balance between analgesia and tolerability

19 Opioid Efficacy in Chronic Pain Most literature surveys & uncontrolled case series RCTs are short dura on <8 months w/ small samples <300 pts Mostly pharmaceu cal company sponsored Pain relief modest Be er analgesia with opioids vs control in all studies (sta s cally significant) Mixed reports on func on Addic on not assessed Balantyne JC, Mao J. NEJM 2003 Kalso E et al. Pain 2004 Eisenberg E et al. JAMA Furlan AD et al. CMAJ 2006

20 Short- ac ng Codeine Hydrocodone Hydromorphone Morphine Oxycodone Oxymorphone Long- ac ng Fentanyl transdermal Extended release morphine Extended release oxycodone Extended release oxymorphone Methadone Insufficient evidence to determine whether long- ac ng opioids are more effec ve or safer than short- ac ng opioids Chou R et al. J Pain Symptom Manage 2003, Argoff C, Silvershein DI. Mayo Clin Proc Currently there are NO abuse resistant opioids or formula ons Stanos SP et al. Mayo Clin Proc. 2012;87(7):

21 Tramadol (immediate and extended release) Mu- opioid agonist Norepinephrine and serotonin reuptake inhibitor Seizure risk Physical dependence Not scheduled as a controlled substance but has addic on poten al Tapentadol (immediate and extended release) Mu- opioid agonist Norepinephrine reuptake inhibitor Physical dependence Schedule II controlled substance with addic on poten al Medical Letter April 2010

22 Methadone is Different NMDA receptor antagonist Less euphoria (po) 5HT, NE uptake inhibi on No neurotoxic metabolites Inexpensive Long, variable, unpredictable half- life Analgesia 6-8 hours Serum t½ hours QTc prolonga on, risk of torsade de points

23 Exploit Synergism Ra onal Polypharmacy Gilron I et al NEJM 2005

24 Allergies are rare Opioid Safety and Risks Side effects are common Nausea, seda on, cons pa on, urinary reten on, swea ng Respiratory depression sleep apnea Organ toxici es are rare Suppression of hypothalamic- pituitary- gonadal axis >50 mg (MSO 4 equivalents) assoc w/ 2X increase in fracture risk Worsening pain (hyperalgesia in some pa ents) Addic on Overdose at high doses when combined w/ other seda ves Saunders KW et al. J Gen Med 2010, Dunn KM et al. Ann Intern Med 2010 Li X et al. Brain Res Mol Brain Res 2001, Doverty M et al. Pain 2001, Angst MS, Clark JD. Anesthesiology 2006

25 Opioid Misuse/Addic on Risk Published rates of abuse and/or addic on in chronic pain popula ons are 3-19% Known risk factors for addic on to any substance are good predictors for problema c prescrip on opioid use Young age Personal history of substance abuse Illicit, prescrip on, alcohol, nico ne Family history of substance abuse Legal history (DUI, incarcera on) Mental health problems Akbik H et al. JPSM 2006 Ives T et al. BMC Health Services Research 2006 Liebschutz JM et al. J of Pain 2010 Michna E el al. JPSM 2004 Reid MC et al JGIM 2002

26 Overdose Risk Risk of fatal overdose seems directly related to the maximum prescribed daily opioid Doses (MSO 4 equivalents) mg/d had a 3.7- fold increase in overdose risk Doses >100 mg/d had an 8.9- fold increase in overdose risk with a 1.8% annual overdose rate Dunn KM et al. Ann Intern Med 2010 Braden JB et al. Arch Intern Med 2010 Bohnert ASB et al. JAMA 2011

27 When Are Opioids Indicated? Pain is moderate to severe Pain has significant impact on func on Pain has significant impact on quality of life Non- opioid pharmacotherapy has been tried and failed Pa ent agreeable to have opioid use closely monitored (e.g. pill counts, urine drug tes ng)

28 Universal Precau ons (not evidence- based but has become standard of care) Agreements contracts, informed consent Assess for opioid misuse risk (e.g., ORT) Monitor benefit & harm w/ frequent face- to- face visits Monitor for adherence, addic on and diversion Urine drug tes ng Pill counts Prescrip on monitoring program data FSMB Guidelines Gourlay DL, Heit HA. Pain Medicine 2005 Chou R et al. J Pain 2009

29 Educa onal and informa onal Ar culate ra onale and risks of treatment Ar culate monitoring Ar culates response to aberrant med- taking behaviors Takes pressure off providers to make individual decisions Our clinic policy is Efficacy not well established (although no evidence of a nega ve impact on pa ent outcomes) No standard or validated form Fishman SM. Clin J Pain, 2002; Arnold Am J of Medicine, 2006, Starrels Ann Intern Med

30 Side effects (short and long term) Physical dependence, tolerance Risk of drug interac ons/over- seda on Risk of impairment Risk of abuse, addic on Legal responsibili es (disposing, sharing, selling) Opioid medica on test Paterick et al. Mayo Clinic Proc. 2008

31 Krebs EE, et al. J Gen Intern Med. 2009

32 Assessing Opioid Misuse Risk ORT: Opioid Risk Tool SOAPP: Screener & Opioid Assessment for Pa ents w/ Pain STAR: Screening Tool for Addic on Risk SISAP: Screening Instrument for Substance Abuse Poten al PDUQ: Prescrip on Drug Use Ques onnaire No gold standard Lack rigorous tes ng Webster et al. Pain Med Butler et al. J Pain. 2008; Adams et al. J Pain Symptom Manage, 2004

33 Opioid Risk Tool (ORT) Female Male Family history of substance abuse Alcohol 1 3 Illegal drugs 2 3 Prescrip on drugs 4 4 Personal history of substance abuse Alcohol 3 3 Illegal drugs 4 4 Prescrip on drugs 5 5 Age between years 1 1 History of preadolescent sexual abuse 3 0 Psychological disease ADHD, OCD, bipolar, schizophrenia 2 2 Depression 1 1 Scoring 0-3 low risk 4-7 moderate risk >8 high risk Webster LR, Webster RM. Pain Medicine, 2006

34 Evidence of therapeu c adherence Evidence of non- use of illicit drugs Know limita ons of test and your lab Know a toxicologist/clinical pathologist Complex, but necessary, pa ent- physician communica on If I send your urine right now, what will I find in it Your urine drug test was abnormal, can you tell me about it Document me of last medica on use Inappropriate interpreta on of results may adversely affect clinical decisions Gourlay DL, Heit HA, Caplan YH. Urine drug testing in primary care. Dispelling myths and designing strategies monograph (

35 Self- reported drug use among pain pa ents is unreliable Fleming MF et al. J Pain 2007 Fisbain DA et al. Clin J Pain 1999 Berndt S, et al. Pain 1993 Behavioral observa ons detects only some problems Wasan AJ et al. Clin J Pain 2007 Katz NP et al. Anesth Analg 2003 May improve adherence (e.g., decreased illicit drug use) Pesce A et al. Pain Physician 2011 Starrels J et al. Ann Intern Med 2010 Manchikan L et al. Pain Physician 2006 Evolving standard of care Chou R et al. J Pain 2009 Tescot AM et al. Pain Physician 2008 Federa on of State Medical Boards, 2004 Gary M. Reisfield, M.D. International Conference on Opioids, June 11, 2012

36 Confirm medica on adherence Minimize diversion My strategies 28 day (rather than 30 day) supply All pa ents expected to bring remaining pills at each visit If pa ent forgets pills, schedule return visit with in a week For high risk pa ent, use random call- backs

37 Monitoring for Harm Prescrip on Monitoring Program

38 Monitoring is a lot of work engage office staff Medical assistant or recep onist document the pa ent s follow- up with lab tes ng verify that lab results have been received determine whether pa ents have followed through with PT, consulta ons, etc. track of the frequency of follow- up office visits Nursing staff manage and monitor prescrip on refills Conduct pain assessments and other clinical informa on

39 Opioids for Chronic Pain: Communicating with Patients: Maximizing Benefits and Minimizing Risks Jane Liebschutz, MD, MPH, FACP Associate Professor of Medicine Boston University School of Medicine Boston Medical Center

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41 VS. Nicolaidis, 2011 Pain Medicine

42 The Risk-Benefit Framework Judge the Treatment, Not the Patient Inappropriate Is the patient good or bad? Does the patient deserve opioid analgesics? Should this patient be punished or rewarded? Should I trust him/her? If I give the patient opioids, he/she will do X. Appropriate Do the benefits of this treatment outweigh the untoward effects and risks in this patient (or to society)?

43 Link opioid prescribing to functional benefits Present all prescriptions as trials Monitor for adverse effects Set realistic expectations Specify consequences for actions Use a risk-benefit model to stay in caring provider role, even while stopping meds

44 Patient fears that you think the pain is imaginary FIRST Listen to pain history Show empathy for patient experience Validate that you believe pain is real SECOND Discuss factors which worsen pain and limit treatment (i.e. abuse, mental health)

45 Points to highlight: Opioids are an imperfect treatment for chronic pain Benefits vs. risks is useful framework

46 Explain monitoring tools used to protect patient Set level of monitoring to match risk Discuss medication risks: Sedation, Constipation, Physical Dependence and Addiction Dangers of driving and hazardous work Responsibility to monitor for signs of harm

47 Discussing Benefits

48 Se ng Goals for Next Visit SMART goals Specific Measurable Action-oriented Realistic Time-sensitive Offer prescriptions as a test of the medication SET EXPECTATIONS

49 To continue opioids: There must be actual functional benefit Benefit must outweigh observed or potential harms You do not have to prove addiction or diversion, only assess risk-benefit ratio

50 Be careful of... Pseudo- Opioid Resistance Some patients with adequate pain relief believe it is not in their best interest to report pain relief Fear that care would be reduced Fear that physician may decrease efforts to diagnose problem Evers GC. Support Care Cancer. 1997

51 Link continuation of opioids to demonstration of benefit Enhances trust Aligns treatment goals Decreases need to prove that pain is terrible My meds allow me to do X, so the treatment is helping.

52 Reassess factors affecting pain Re-attempt to treat underlying disease and co-morbidities Consider escalating dose as a test No effect = no benefit If benefit cannot outweigh risks STOP opioids

53 Demonstrate compassion towards patient s pain, even without opioid Rx Express frustration re: lack of a good solution Focus on patient s strengths Encourage therapies for coping with pain Schedule close follow-ups

54 Matching Action to DDx Tolerance of risk depends on benefit Miscommunication re-clarify rules once Pseudo-addiction increase dose as TEST Addiction stop opioids and refer to addiction treatment. +/- bridge or taper Diversion stop opioids Match action to most likely cause Not punishment to level of infraction

55 Explain why breach of agreement raises your concern for possible addiction: Benefits no longer outweigh risks I cannot responsibly continue prescribing opioids as I feel it would cause you more harm than good Always offer referral to substance abuse treatment Maintain a risk-benefit mindset

56 Exit Strategy Discussing Possible Addiction Explain why urine drug screen raises your concern for possible addiction. Benefits no longer outweighing risks. I cannot responsibly continue prescribing opioids as I feel it would cause you more harm than good. Always offer referral to substance abuse treatment. Stay 100% in Benefit/Risk of Med mindset.

57 Exit Strategy Discussing Lack of Benefit Stress how much you believe / empathize with patient s pain severity and impact. Express frustration re: lack of good pill to fix it. Focus on patient s strengths. Encourage therapies for coping with pain. Show commitment to continue caring about patient and pain, even without opioid rx. Schedule close follow-ups during and after taper.

58 Avoiding Abandonment Documentation of risk/benefit discussion and why treatment discontinued Allow for medically appropriate taper Restate commitment to work with patient on pain and addiction Refer to specialty pain treatment providers Alert patient to addiction treatment resources See patient frequently and monitor for progress and safety Copy to patient and to chart Fishbain DA Pain Medicine 2009

59 Clarify that patient should get evaluation by expert in addiction treatment Reinforce commitment to treat pain, but addiction limits your ability to treat with opioids Leave door open for return If patient is not committed to addiction treatment, Do not taper meds or bridge opioids Opioid withdrawal is not life-threatening

60 Much harder and more painful Discuss why breach of contract leads to concern for diversion or addiction Leave door open for possibility that you are wrong Offer addiction and detox resources Discuss your responsibility to society and inability to prescribe when there is any chance of diversion

61 Link opioid prescribing to functional benefits Present all prescriptions as trials Monitor for adverse effects Set realistic expectations Specify consequences for actions Use a risk-benefit model to stay in caring provider role, even while stopping meds