of Pain Medicine 25th Annual Meeting

Transcription

1 2009 American AAPM Awards Academy of Pain Medicine 25th Annual Meeting Hilton Hawaiian Village, Honolulu, HI January 28 31, 2009 Celebrating 25 Years as the Voice of Pain Medicine A

2 Join us for a CME lunch symposium Pain Management in Clinical Approaches to a Older Adults: Complex Problem Thursday, January 29, :15 AM-12:30 PM Tapa 3 Hilton Hawaiian Village Honolulu, Hawaii This activity has been approved for AMA PRA category 1 credit(s) TM. This educational activity is jointly sponsored by Postgraduate Institute for Medicine and MK Medical Communications, LLC. This activity is supported by an educational grant from Endo Pharmaceuticals, Inc. Bruce D. Nicholson, MD (Program Chair) Clinical Associate Professor, Anesthesia Penn State University School of Medicine Milton S. Hershey Medical Center Director, Division of Pain Medicine Lehigh Valley Hospital and Health Network This is an official independent satellite symposium held in conjunction with the American Academy of Pain Medicine s 25th Annual Meeting.

3 Important Safety Information Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders. Patients of all ages started on therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Cymbalta is not approved for use in pediatric patients. Cymbalta should not be used concomitantly with monoamine oxidase inhibitors (MAOIs) or in patients with uncontrolled narrowangle glaucoma. Clinical worsening and suicide risk: All patients being treated with an antidepressant for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially within the first few months of treatment and when changing the dose. Consider changing the therapeutic regimen if the depression is persistently worse or there are symptoms that are severe, sudden, or were not part of the patient s presentation. If discontinuing treatment, taper the medication. Families and caregivers of patients being treated with antidepressants for any indication should be alerted about the need to monitor patients. Hepatic failure, sometimes fatal, has been reported in patients treated with Cymbalta. Cymbalta should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Cymbalta should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. Cases of orthostatic hypotension and/or syncope as well as cases of hyponatremia have been reported. Development of a potentially life-threatening serotonin syndrome may occur with SNRIs and SSRIs, including Cymbalta treatment, particularly with concomitant use of serotonergic drugs, including triptans. Concomitant use is not recommended. SSRIs and SNRIs, including Cymbalta, may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with concomitant use of Cymbalta and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation. On discontinuation, adverse events, some of which may be serious, have been reported with SSRIs and SNRIs. A gradual reduction in dose rather than abrupt cessation is recommended when possible. Co-administration of Cymbalta with potent CYP1A2 inhibitors or thioridazine should be avoided. Caution is advised in using Cymbalta in patients with conditions that may slow gastric emptying (eg, some diabetics). Cymbalta should ordinarily not be administered to patients with any hepatic insufficiency or patients with end-stage renal disease (requiring dialysis) or severe renal impairment (CrCl <30 ml/min). As observed in DPNP clinical trials, Cymbalta treatment worsens glycemic control in some patients with diabetes. In the extension phases up to 52 weeks, an increase in HbA 1c in both the Cymbalta (0.5%) and routine care groups (0.2%) was noted. If symptoms of urinary hesitation develop during Cymbalta treatment, this effect may be drug-related. In postmarketing experience, urinary retention has been observed. The most commonly reported adverse events ( 5% and at least twice placebo) for Cymbalta vs placebo in controlled clinical trials (N=4843 vs 3048) were: nausea, dry mouth, somnolence,* constipation,* decreased appetite,* and increased sweating. * Events for which there was a significant dose-dependent relationship in fixed-dose studies, excluding three MDD studies which did not have a placebo lead-in period or dose titration. Presenting effective pain relief for your patients with fibromyalgia or diabetic peripheral neuropathic pain Cymbalta is approved for the management of fibromyalgia and diabetic peripheral neuropathic pain. Relax in booth 616 as you enjoy refreshments and hear our guest speakers talk about these 2 different, painful conditions. See Brief Summary of full Prescribing Information, including Boxed Warning, on reverse side. DD PRINTED IN USA 2009, Lilly USA, LLC. ALL RIGHTS RESERVED. Cymbalta is a registered trademark of Eli Lilly and Company.

4 CYMBALTA (duloxetine hydrochloride) Delayed-release Capsules Brief Summary: Consult the package insert for complete prescribing information. WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Cymbalta or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Cymbalta is not approved for use in pediatric patients. [See Warnings and Precautions and Use in Specific Populations.] INDICATIONS AND USAGE: Major Depressive Disorder Cymbalta is indicated for the acute and maintenance treatment of major depressive disorder (MDD). Generalized Anxiety Disorder Cymbalta is indicated for the acute treatment of generalized anxiety disorder (GAD). Diabetic Peripheral Neuropathic Pain Cymbalta is indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy. Fibromyalgia Cymbalta is indicated for the management of fibromyalgia (FM). CONTRAINDICATIONS: Monoamine Oxidase Inhibitors Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serious, sometimes fatal, drug interactions with serotonergic drugs. These interactions may include hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued serotonin reuptake inhibitors and are then started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome [see Warnings and Precautions]. Uncontrolled Narrow-Angle Glaucoma In clinical trials, Cymbalta use was associated with an increased risk of mydriasis; therefore, its use should be avoided in patients with uncontrolled narrow-angle glaucoma [see Warnings and Precautions]. WARNINGS AND PRECAUTIONS: Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk of differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1. Table 1 Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated Increases Compared to Placebo <18 14 additional cases additional cases Decreases Compared to Placebo fewer case 65 6 fewer cases No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient s presenting symptoms. If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that discontinuation can be associated with certain symptoms [see Warnings and Precautions, Discontinuation of Treatment with Cymbalta]. Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Cymbalta should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose. Screening Patients for Bipolar Disorder A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that Cymbalta (duloxetine) is not approved for use in treating bipolar depression. Hepatotoxicity There have been reports of hepatic failure, sometimes fatal, in patients treated with Cymbalta. These cases have presented as hepatitis with abdominal pain, hepatomegaly, and elevation of transaminase levels to more than twenty times the upper limit of normal with or without jaundice, reflecting a mixed or hepatocellular pattern of liver injury. Cymbalta should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Cases of cholestatic jaundice with minimal elevation of transaminase levels have also been reported. Other postmarketing reports indicate that elevated transaminases, bilirubin, and alkaline phosphatase have occurred in patients with chronic liver disease or cirrhosis. Cymbalta increased the risk of elevation of serum transaminase levels in development program clinical trials. Liver transaminase elevations resulted in the discontinuation of 0.3% (82/27,229) of Cymbalta-treated patients. In these patients, the median time to detection of the transaminase elevation was about two months. In placebo-controlled trials in any indication, elevation of ALT >3 times the upper limit of normal occurred in 1.1% (85/7,632) of Cymbalta-treated patients compared to 0.2% (13/5,578) of placebo-treated patients. In placebo-controlled studies using a fixed dose design, there was evidence of a dose response relationship for ALT and AST elevation of >3 times the upper limit of normal and >5 times the upper limit of normal, respectively. Because it is possible that duloxetine and alcohol may interact to cause liver injury or that duloxetine may aggravate pre-existing liver disease, Cymbalta should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. Orthostatic Hypotension and Syncope Orthostatic hypotension and syncope have been reported with therapeutic doses of duloxetine. Syncope and orthostatic hypotension tend to occur within the first week of therapy but can occur at any time during duloxetine treatment, particularly after dose increases. The risk of blood pressure decreases may be greater in patients taking concomitant medications that induce orthostatic hypotension (such as antihypertensives) or are potent CYP1A2 inhibitors [see Warnings and Precautions and Drug Interactions] and in patients taking duloxetine at doses above 60 mg daily. Consideration should be given to discontinuing duloxetine in patients who experience symptomatic orthostatic hypotension and/ or syncope during duloxetine therapy. Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome may occur with SNRIs and SSRIs, including Cymbalta treatment, particularly with concomitant use of serotonergic drugs (including triptans) and with drugs which impair metabolism of serotonin (including MAOIs). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The concomitant use of Cymbalta with MAOIs intended to treat depression is contraindicated [see Contraindications]. If concomitant treatment of Cymbalta with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases [see Drug Interactions]. The concomitant use of Cymbalta with serotonin precursors (such as tryptophan) is not recommended [see Drug Interactions]. Abnormal Bleeding SSRIs and SNRIs, including duloxetine, may increase the risk of bleeding events. Concomitant use of aspirin, non-steroidal anti-inflammatory drugs, warfarin, and other anti-coagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with Cymbalta (duloxetine hydrochloride) PV 5909 AMP Cymbalta (duloxetine hydrochloride) PV 5909 AMP

5 serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to SSRIs and SNRIs use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages. Patients should be cautioned about the risk of bleeding associated with the concomitant use of duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation. Discontinuation of Treatment with Cymbalta Discontinuation symptoms have been systematically evaluated in patients taking duloxetine. Following abrupt or tapered discontinuation in placebo-controlled clinical trials, the following symptoms occurred at a rate greater than or equal to 1% and at a significantly higher rate in duloxetine-treated patients compared to those discontinuing from placebo: dizziness, nausea, headache, fatigue, paresthesia, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety, hyperhidrosis and vertigo. During marketing of other SSRIs and SNRIs (serotonin and norepinephrine reuptake inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. Although these events are generally self-limiting, some have been reported to be severe. Patients should be monitored for these symptoms when discontinuing treatment with Cymbalta. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. Activation of Mania/Hypomania In placebo-controlled trials in patients with major depressive disorder, activation of mania or hypomania was reported in 0.1% (2/2489) of duloxetine-treated patients and 0.1% (1/1625) of placebo-treated patients. No activation of mania or hypomania was reported in DPNP, GAD, or fibromyalgia placebo-controlled trials. Activation of mania or hypomania has been reported in a small proportion of patients with mood disorders who were treated with other marketed drugs effective in the treatment of major depressive disorder. As with these other agents, Cymbalta should be used cautiously in patients with a history of mania. Seizures Duloxetine has not been systematically evaluated in patients with a seizure disorder and such patients were excluded from clinical studies. In placebo-controlled clinical trials, seizures/convulsions occurred in 0.03% (3/9445) of patients treated with duloxetine and 0.01% (1/6770) of patients treated with placebo. Cymbalta should be prescribed with care in patients with a history of a seizure disorder. Effect on Blood Pressure In clinical trials across indications, relative to placebo, duloxetine treatment was associated with mean increases of up to 2.1 mm Hg in systolic blood pressure and up to 2.3 mm Hg in diastolic blood pressure. There was no significant difference in the frequency of sustained (3 consecutive visits) elevated blood pressure. In a clinical pharmacology study designed to evaluate the effects of duloxetine on various parameters, including blood pressure at supratherapeutic doses with an accelerated dose titration, there was evidence of increases in supine blood pressure at doses up to 200 mg twice daily. At the highest 200 mg twice daily dose, the increase in mean pulse rate was 5.0 to 6.8 beats and increases in mean blood pressure were 4.7 to 6.8 mm Hg (systolic) and 4.5 to 7 mm Hg (diastolic) up to 12 hours after dosing. Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment [see Adverse Reactions, Vital Sign Changes]. Clinically Important Drug Interactions Both CYP1A2 and CYP2D6 are responsible for duloxetine metabolism. Potential for Other Drugs to Affect Cymbalta CYP1A2 Inhibitors Co-administration of Cymbalta with potent CYP1A2 inhibitors should be avoided [see Drug Interactions]. CYP2D6 Inhibitors Because CYP2D6 is involved in duloxetine metabolism, concomitant use of duloxetine with potent inhibitors of CYP2D6 would be expected to, and does, result in higher concentrations (on average of 60%) of duloxetine [see Drug Interactions]. Potential for Cymbalta to Affect Other Drugs Drugs Metabolized by CYP2D6 Co-administration of Cymbalta with drugs that are extensively metabolized by CYP2D6 and that have a narrow therapeutic index, including certain antidepressants (tricyclic antidepressants [TCAs], such as nortriptyline, amitriptyline, and imipramine), phenothiazines and Type 1C antiarrhythmics (e.g., propafenone, flecainide), should be approached with caution. Plasma TCA concentrations may need to be monitored and the dose of the TCA may need to be reduced if a TCA is co-administered with Cymbalta. Because of the risk of serious ventricular arrhythmias and sudden death potentially associated with elevated plasma levels of thioridazine, Cymbalta and thioridazine should not be co-administered [see Drug Interactions]. Other Clinically Important Drug Interactions Alcohol Use of Cymbalta concomitantly with heavy alcohol intake may be associated with severe liver injury. For this reason, Cymbalta should ordinarily not be prescribed for patients with substantial alcohol use [see Warnings and Precautions and Drug Interactions]. CNS Acting Drugs Given the primary CNS effects of Cymbalta, it should be used with caution when it is taken in combination with or substituted for other centrally acting drugs, including those with a similar mechanism of action [see Warnings and Precautions and Drug Interactions]. Hyponatremia Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including Cymbalta. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases with serum sodium lower than 110 mmol/l have been reported and appeared to be reversible when Cymbalta was discontinued. Elderly patients may be at greater risk of developing hyponatremia with SSRIs and SNRIs. Also, patients taking diuretics or who are otherwise volume depleted may be at greater risk [see Use in Specific Populations]. Discontinuation of Cymbalta should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted. Use in Patients with Concomitant Illness Clinical experience with Cymbalta in patients with concomitant systemic illnesses is limited. There is no information on the effect that alterations in gastric motility may have on the stability of Cymbalta s enteric coating. In extremely acidic conditions, Cymbalta, unprotected by the enteric coating, may undergo hydrolysis to form naphthol. Caution is advised in using Cymbalta in patients with conditions that may slow gastric emptying (e.g., some diabetics). Cymbalta has not been systematically evaluated in patients with a recent history of myocardial infarction or unstable coronary artery disease. Patients with these diagnoses were generally excluded from clinical studies during the product s premarketing testing. Hepatic Insufficiency Cymbalta should ordinarily not be used in patients with hepatic insufficiency [see Warnings and Precautions and Use in Specific Populations]. Severe Renal Impairment Cymbalta should ordinarily not be used in patients with end-stage renal disease or severe renal impairment (creatinine clearance <30 ml/min). Increased plasma concentration of duloxetine, and especially of its metabolites, occur in patients with end-stage renal disease (requiring dialysis) [see Use in Specific Populations]. Controlled Narrow-Angle Glaucoma In clinical trials, Cymbalta was associated with an increased risk of mydriasis; therefore, it should be used cautiously in patients with controlled narrow-angle glaucoma [see Contraindications]. Glycemic Control in Patients with Diabetes As observed in DPNP trials, Cymbalta treatment worsens glycemic control in some patients with diabetes. In three clinical trials of Cymbalta for the management of neuropathic pain associated with diabetic peripheral neuropathy, the mean duration of diabetes was approximately 12 years, the mean baseline fasting blood glucose was 176 mg/dl, and the mean baseline hemoglobin A 1c (HbA 1c) was 7.8%. In the 12-week acute treatment phase of these studies, Cymbalta was associated with a small increase in mean fasting blood glucose as compared to placebo. In the extension phase of these studies, which lasted up to 52 weeks, mean fasting blood glucose increased by 12 mg/dl in the Cymbalta group and decreased by 11.5 mg/dl in the routine care group. HbA 1c increased by 0.5% in the Cymbalta and by 0.2% in the routine care groups. Urinary Hesitation and Retention Cymbalta is in a class of drugs known to affect urethral resistance. If symptoms of urinary hesitation develop during treatment with Cymbalta, consideration should be given to the possibility that they might be drug-related. In post marketing experience, cases of urinary retention have been observed. In some instances of urinary retention associated with duloxetine use, hospitalization and/or catheterization has been needed. Laboratory Tests No specific laboratory tests are recommended. ADVERSE REACTIONS: Clinical Trial Data Sources The data described below reflect exposure to duloxetine in placebo-controlled trials for MDD (N=2327), GAD (N=668), DPNP (N=568) and FM (N=876). The population studied was 17 to 89 years of age; 64.8%, 64.7%, 38.7%, and 94.6% female; and 85.5%, 84.6%, 77.6%, and 88% Caucasian for MDD, GAD, DPNP, and FM, respectively. Most patients received doses of a total of 60 to 120 mg per day. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Reactions reported during the studies were not necessarily caused by the therapy, and the frequencies do not reflect investigator impression (assessment) of causality. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions Reported as Reasons for Discontinuation of Treatment in Placebo- Controlled Trials Major Depressive Disorder Approximately 9% (209/2327) of the patients who received duloxetine in placebo-controlled trials for MDD discontinued treatment due to an adverse reaction, compared with 4.7% (68/1460) of the patients receiving placebo. Nausea (duloxetine 1.3%, placebo 0.5%) was the only common adverse reaction reported as a reason for discontinuation and considered to be drug-related (i.e., discontinuation occurring in at least 1% of the duloxetine-treated patients and at a rate of at least twice that of placebo). Generalized Anxiety Disorder Approximately 15.3% (102/668) of the patients who received duloxetine in placebo-controlled trials for GAD discontinued treatment due to an adverse reaction, compared with 4.0% (20/495) for placebo. Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (duloxetine 3.7%, placebo 0.2%), vomiting (duloxetine 1.3%, placebo 0.0%), and dizziness (duloxetine 1.0%, placebo 0.2%). Diabetic Peripheral Neuropathic Pain Approximately 14.3% (81/568) of the patients who received duloxetine in placebo-controlled trials for DPNP discontinued treatment due to an adverse reaction, compared with 7.2% (16/223) for placebo. Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) were nausea (duloxetine 3.5%, placebo 0.4%), dizziness (duloxetine 1.6%, placebo 0.4%), somnolence (duloxetine 1.6%, placebo 0.0%), and fatigue (duloxetine 1.1%, placebo 0.0%). Fibromyalgia Approximately 19.5% (171/876) of the patients who received duloxetine in 3 to 6 month placebo-controlled trials for FM discontinued treatment due to an adverse reaction, compared with 11.8% (63/535) for placebo. Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (duloxetine 1.9%, placebo 0.7%), somnolence (duloxetine 1.5%, placebo 0.0%), and fatigue (duloxetine 1.3%, placebo 0.2%). Adverse Reactions Occurring at an Incidence of 5% or More and at least Twice Placebo Among Duloxetine-Treated Patients in Placebo-Controlled Trials Pooled Trials for all Approved Indications The most commonly observed adverse reactions in Cymbalta-treated patients (incidence of at least 5% and at least twice the incidence in placebo patients) were nausea, dry mouth, constipation, somnolence, hyperhidrosis, and decreased appetite. In addition to the adverse reactions listed above, DPNP trials also included dizziness and asthenia. Adverse Reactions Occurring at an Incidence of 5% or More Among Duloxetine- Treated Patients in Placebo-Controlled Trials The incidence of treatment-emergent adverse reactions in placebo-controlled trials (N=4843 Cymbalta; N=3048 placebo) for approved indications that occurred in 5% or more of patients treated with duloxetine and with an incidence greater than placebo were: nausea, headache, dry mouth, fatigue (includes asthenia), insomnia (includes middle insomnia, early morning awakening, and initial insomnia), dizziness, somnolence (includes hypersomnia and sedation), constipation, diarrhea, decreased appetite (includes anorexia), and hyperhidrosis. Events for which there was a significant dose-dependent relationship in fixed-dose studies, excluding three MDD studies which did not have a placebo lead-in period or dose titration. Adverse Reactions Occurring at an Incidence of 2% or More Among Duloxetine- Treated Patients in Placebo-Controlled Trials Pooled MDD and GAD Trials Table 3 in full PI gives the incidence of treatment-emergent adverse reactions in MDD and GAD placebo-controlled trials (N=2995 Cymbalta; N=1955 placebo) for approved indications that occurred in 2% or more of Cymbalta (duloxetine hydrochloride) PV 5909 AMP Cymbalta (duloxetine hydrochloride) PV 5909 AMP

6 patients treated with duloxetine and with an incidence greater than placebo were: Cardiac Disorders palpitations; Eye Disorders vision blurred; Gastrointestinal Disorders nausea, dry mouth, diarrhea, constipation, abdominal pain (includes abdominal pain upper, abdominal pain lower, abdominal tenderness, abdominal discomfort, and gastrointestinal pain), vomiting; General Disorders and Administration Site Conditions fatigue (includes asthenia); Investigations weight decreased ; Metabolism and Nutrition Disorders decreased appetite (includes anorexia); Nervous System Disorders dizziness, somnolence (includes hypersomnia and sedation), tremor; Psychiatric Disorders insomnia (includes middle insomnia, early morning awakening, and initial insomnia), agitation (includes feeling jittery, nervousness, restlessness, tension, and psychomotor agitation), anxiety, decreased libido (includes loss of libido), orgasm abnormal (includes anorgasmia), abnormal dreams (includes nightmare); Reproductive System and Breast Disorders erectile dysfunction, ejaculation delayed, ejaculation disorder (includes ejaculation failure and ejaculation dysfunction); Respiratory, Thoracic, and Mediastinal Disorders yawning; Skin and Subcutaneous Tissue Disorders hyperhidrosis; Vascular Disorders hot flush. Events for which there was a significant dose-dependent relationship in fixed-dose studies, excluding three MDD studies which did not have a placebo lead-in period or dose titration. Diabetic Peripheral Neuropathic Pain Treatment-emergent adverse events that occurred in 2% or more of patients treated with Cymbalta in the premarketing acute phase of DPNP placebocontrolled trials (N=115 Cymbalta 20 mg once daily; N=228 Cymbalta 60 mg once daily; N=225 Cymbalta 60 mg twice daily; N=223 placebo) with an incidence greater than placebo were: Gastrointestinal Disorders nausea, constipation, diarrhea, dry mouth, vomiting, dyspepsia, loose stools; General Disorders and Administration Site Conditions fatigue, asthenia, pyrexia; Infections and Infestations nasopharyngitis; Metabolism and Nutrition Disorders decreased appetite, anorexia; Musculoskeletal and Connective Tissue Disorders muscle cramp, myalgia; Nervous System Disorders somnolence, headache, dizziness, tremor; Psychiatric Disorders insomnia; Renal and Urinary Disorders pollakiuria; Reproductive System and Breast Disorders erectile dysfunction; Respiratory, Thoracic and Mediastinal Disorders cough, pharyngolaryngeal pain; Skin and Subcutaneous Tissue Disorders hyperhidrosis. Fibromyalgia Treatment-emergent adverse events that occurred in 2% or more of patients treated with Cymbalta in the premarketing acute phase of FM placebo-controlled trials (N=876 Cymbalta; N=535 placebo) and with an incidence greater than placebo were: Cardiac Disorders palpitations; Eye Disorders vision blurred; Gastrointestinal Disorders nausea, dry mouth, constipation, diarrhea, dyspepsia; General Disorders and Administration Site Conditions fatigue (includes asthenia); Immune System Disorders seasonal allergy; Infections and Infestations upper respiratory tract infection, urinary tract infection, influenza, gastroenteritis viral; Investigations weight increased; Metabolism and Nutrition Disorders decreased appetite (includes anorexia); Musculoskeletal and Connective Tissue Disorders musculoskeletal pain, muscle spasm; Nervous System Disorders headache, dizziness, somnolence (includes hypersomnia and sedation), tremor, paraesthesia, migraine, dysgeusia; Psychiatric Disorders insomnia (includes middle insomnia, early morning awakening, and initial insomnia), agitation (includes feeling jittery, nervousness, restlessness, tension, and psychomotor agitation), sleep disorder, abnormal dreams (includes nightmare), orgasm abnormal (includes anorgasmia), libido decreased (includes loss of libido); Reproductive System and Breast Disorders ejaculation disorder (includes ejaculation failure and ejaculation dysfunction), penis disorder; Respiratory, Thoracic, and Mediastinal Disorders cough, pharyngolaryngeal pain; Skin and Subcutaneous Tissue Disorders hyperhidrosis, rash, pruritus; Vascular Disorders hot flush. Effects on Male and Female Sexual Function Changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of psychiatric disorders or diabetes, but they may also be a consequence of pharmacologic treatment. Because adverse sexual reactions are presumed to be voluntarily underreported, the Arizona Sexual Experience Scale (ASEX), a validated measure designed to identify sexual side effects, was used prospectively in 4 MDD placebo-controlled trials. In these trials, patients treated with Cymbalta experienced significantly more sexual dysfunction, as measured by the total score on the ASEX, than did patients treated with placebo. Gender analysis showed that this difference occurred only in males. Males treated with Cymbalta experienced more difficulty with ability to reach orgasm (ASEX Item 4) than males treated with placebo. Females did not experience more sexual dysfunction on Cymbalta than on placebo as measured by ASEX total score. Physicians should routinely inquire about possible sexual side effects. See Table 6 in full PI for specific ASEX results. Vital Sign Changes In clinical trials across indications, relative to placebo, duloxetine treatment was associated with mean increases of up to 2.1 mm Hg in systolic blood pressure and up to 2.3 mm Hg in diastolic blood pressure. There was no significant difference in the frequency of sustained (3 consecutive visits) elevated blood pressure [see Warnings and Precautions]. Duloxetine treatment, for up to 26-weeks in placebo-controlled trials typically caused a small increase in heart rate compared to placebo of up to 3-4 beats per minute. Weight Changes In placebo-controlled clinical trials, MDD and GAD patients treated with Cymbalta for up to 10 weeks experienced a mean weight loss of approximately 0.5 kg, compared with a mean weight gain of approximately 0.2 kg in placebo-treated patients. In DPN placebocontrolled clinical trials, patients treated with Cymbalta for up to 13-weeks experienced a mean weight loss of approximately 1.1 kg, compared with a mean weight gain of approximately 0.2 kg in placebo-treated patients. In fibromyalgia studies, patients treated with Cymbalta for up to 26 weeks experienced a mean weight loss of approximately 0.4 kg compared with a mean weight gain of approximately 0.3 kg in placebo-treated patients. In one long-term fibromyalgia 60-week uncontrolled study, duloxetine patients had a mean weight increase of 0.7 kg. Laboratory Changes Cymbalta treatment in placebo-controlled clinical trials, was associated with small mean increases from baseline to endpoint in ALT, AST, CPK, and alkaline phosphatase; infrequent, modest, transient, abnormal values were observed for these analytes in Cymbaltatreated patients when compared with placebo-treated patients [see Warnings and Precautions]. Electrocardiogram Changes Electrocardiograms were obtained from duloxetine-treated patients and placebo-treated patients in clinical trials lasting up to 13-weeks. No clinically significant differences were observed for QTc, QT, PR, and QRS intervals between duloxetine-treated and placebo-treated patients. There were no differences in clinically meaningful QTcF elevations between duloxetine and placebo. In a positive-controlled study in healthy volunteers using duloxetine up to 200 mg twice daily, no prolongation of the corrected QT interval was observed. Other Adverse Reactions Observed During the Premarketing and Postmarketing Clinical Trial Evaluation of Duloxetine Following is a list of treatment-emergent adverse reactions reported by patients treated with duloxetine in clinical trials. In clinical trials of all indications, 27,229 patients were treated with duloxetine. Of these, 29% (7,886) took duloxetine for at least 6 months, and 13.3% (3,614) for at least one year. The following listing is not intended to include reactions (1) already listed in previous tables or elsewhere in labeling, (2) for which a drug cause was remote, (3) which were so general as to be uninformative, (4) which were not considered to have significant clinical implications, or (5) which occurred at a rate equal to or less than placebo. Reactions are categorized by body system according to the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients. Cardiac Disorders Frequent: palpitations; Infrequent: myocardial infarction and tachycardia; Ear and Labyrinth Disorders Frequent: vertigo; Infrequent: ear pain and tinnitus; Endocrine Disorders Infrequent: hypothyroidism; Eye Disorders Frequent: vision blurred; Infrequent: diplopia and visual disturbance; Gastrointestinal Disorders Frequent: flatulence; Infrequent: eructation, gastritis, halitosis, and stomatitis; Rare: gastric ulcer, hematochezia, and melena; General Disorders and Administration Site Conditions Frequent: chills/rigors; Infrequent: feeling abnormal, feeling hot and/or cold, malaise, and thirst; Rare: gait disturbance; Infections and Infestations Infrequent: gastroenteritis and laryngitis; Investigations Frequent: weight increased; Infrequent: blood cholesterol increased; Metabolism and Nutrition Disorders Infrequent: dehydration and hyperlipidemia; Rare: dyslipidemia; Musculoskeletal and Connective Tissue Disorders Frequent: musculoskeletal pain; Infrequent: muscle tightness and muscle twitching; Nervous System Disorders Frequent: dysgeusia, lethargy, and parasthesia/hypoesthesia; Infrequent: disturbance in attention, dyskinesia, myoclonus, and poor quality sleep; Rare: dysarthria; Psychiatric Disorders Frequent: abnormal dreams and sleep disorder; Infrequent: apathy, bruxism, disorientation/ confusional state, irritability, mood swings, and suicide attempt; Rare: completed suicide; Renal and Urinary Disorders Infrequent: dysuria, micturition urgency, nocturia, polyuria, and urine odor abnormal.; Reproductive System and Breast Disorders Frequent: anorgasmia/orgasm abnormal; Infrequent: menopausal symptoms, and sexual dysfunction; Respiratory, Thoracic and Mediastinal Disorders Frequent: yawning; Infrequent: throat tightness; Skin and Subcutaneous Tissue Disorders Infrequent: cold sweat, dermatitis contact, erythema, increased tendency to bruise, night sweats, and photosensitivity reaction; Rare: ecchymosis; Vascular Disorders Frequent: hot flush; Infrequent: flushing, orthostatic hypotension, and peripheral coldness. Postmarketing Spontaneous Reports The following adverse reactions have been identified during postapproval use of Cymbalta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported since market introduction that were temporally related to duloxetine therapy and not mentioned elsewhere in labeling include: anaphylactic reaction, aggression and anger (particularly early in treatment or after treatment discontinuation), angioneurotic edema, erythema multiforme, extrapyramidal disorder, glaucoma, gynecological bleeding, hallucinations, hyperglycemia, hypersensitivity, hypertensive crisis, muscle spasm, rash, supraventricular arrhythmia, tinnitus (upon treatment discontinuation), trismus, and urticaria. Serious skin reactions including Stevens-Johnson Syndrome that have required drug discontinuation and/or hospitalization have been reported with duloxetine. DRUG INTERACTIONS: Both CYP1A2 and CYP2D6 are responsible for duloxetine metabolism. Inhibitors of CYP1A2 When duloxetine 60 mg was co-administered with fluvoxamine 100 mg, a potent CYP1A2 inhibitor, to male subjects (n=14) duloxetine AUC was increased approximately 6-fold, the C max was increased about 2.5-fold, and duloxetine t1/2 was increased approximately 3-fold. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin [see Warnings and Precautions]. Inhibitors of CYP2D6 Concomitant use of duloxetine (40 mg once daily) with paroxetine (20 mg once daily) increased the concentration of duloxetine AUC by about 60%, and greater degrees of inhibition are expected with higher doses of paroxetine. Similar effects would be expected with other potent CYP2D6 inhibitors (e.g., fluoxetine, quinidine) [see Warnings and Precautions]. Dual Inhibition of CYP1A2 and CYP2D6 Concomitant administration of duloxetine 40 mg twice daily with fluvoxamine 100 mg, a potent CYP1A2 inhibitor, to CYP2D6 poor metabolizer subjects (n=14) resulted in a 6-fold increase in duloxetine AUC and C max. Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin) Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the casecontrol and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs or SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when duloxetine is initiated or discontinued [see Warnings and Precautions]. Lorazepam Under steady-state conditions for duloxetine (60 mg Q 12 hours) and lorazepam (2 mg Q 12 hours), the pharmacokinetics of duloxetine were not affected by co-administration. Temazepam Under steady-state conditions for duloxetine (20 mg qhs) and temazepam (30 mg qhs), the pharmacokinetics of duloxetine were not affected by co-administration. Drugs that Affect Gastric Acidity Cymbalta has an enteric coating that resists dissolution until reaching a segment of the gastrointestinal tract where the ph exceeds 5.5. In extremely acidic conditions, Cymbalta, unprotected by the enteric coating, may undergo hydrolysis to form naphthol. Caution is advised in using Cymbalta in patients with conditions that may slow gastric emptying (e.g., some diabetics). Drugs that raise the gastrointestinal ph may lead to an earlier release of duloxetine. However, co-administration of Cymbalta with aluminum- and magnesium-containing antacids (51 meq) or Cymbalta with famotidine, had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose. It is unknown whether the concomitant administration of proton pump inhibitors affects duloxetine absorption [see Warnings and Precautions]. Cymbalta (duloxetine hydrochloride) PV 5909 AMP Cymbalta (duloxetine hydrochloride) PV 5909 AMP

7 Drugs Metabolized by CYP1A2 In vitro drug interaction studies demonstrate that duloxetine does not induce CYP1A2 activity. Therefore, an increase in the metabolism of CYP1A2 substrates (e.g., theophylline, caffeine) resulting from induction is not anticipated, although clinical studies of induction have not been performed. Duloxetine is an inhibitor of the CYP1A2 isoform in in vitro studies, and in two clinical studies the average (90% confidence interval) increase in theophylline AUC was 7% (1%-15%) and 20% (13%-27%) when co-administered with duloxetine (60 mg twice daily). Drugs Metabolized by CYP2D6 Duloxetine is a moderate inhibitor of CYP2D6. When duloxetine was administered (at a dose of 60 mg twice daily) in conjunction with a single 50-mg dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased 3-fold [see Warnings and Precautions]. Drugs Metabolized by CYP2C9 Duloxetine does not inhibit the in vitro enzyme activity of CYP2C9. Inhibition of the metabolism of CYP2C9 substrates is therefore not anticipated, although clinical studies have not been performed. Drugs Metabolized by CYP3A Results of in vitro studies demonstrate that duloxetine does not inhibit or induce CYP3A activity. Therefore, an increase or decrease in the metabolism of CYP3A substrates (e.g., oral contraceptives and other steroidal agents) resulting from induction or inhibition is not anticipated, although clinical studies have not been performed. Drugs Metabolized by CYP2C19 Results of in vitro studies demonstrate that duloxetine does not inhibit CYP2C19 activity at therapeutic concentrations. Inhibition of the metabolism of CYP2C19 substrates is therefore not anticipated, although clinical studies have not been performed. Monoamine Oxidase Inhibitors Switching Patients to or from a Monoamine Oxidase Inhibitor At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with Cymbalta. In addition, at least 5 days should be allowed after stopping Cymbalta before starting an MAOI [see Contraindications and Warnings and Precautions]. Serotonergic Drugs Based on the mechanism of action of SNRIs and SSRIs, including Cymbalta, and the potential for serotonin syndrome, caution is advised when Cymbalta is co-administered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, tramadol, or St. John's Wort. The concomitant use of Cymbalta with other SSRIs, SNRIs or tryptophan is not recommended [see Warnings and Precautions]. Triptans There have been rare postmarketing reports of serotonin syndrome with use of an SSRI and a triptan. If concomitant treatment of Cymbalta with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases [see Warnings and Precautions]. Alcohol When Cymbalta and ethanol were administered several hours apart so that peak concentrations of each would coincide, Cymbalta did not increase the impairment of mental and motor skills caused by alcohol. In the Cymbalta clinical trials database, three Cymbalta-treated patients had liver injury as manifested by ALT and total bilirubin elevations, with evidence of obstruction. Substantial intercurrent ethanol use was present in each of these cases, and this may have contributed to the abnormalities seen [see Warnings and Precautions]. CNS Drugs [see Warnings and Precautions]. Drugs Highly Bound to Plasma Protein Because duloxetine is highly bound to plasma protein, administration of Cymbalta to a patient taking another drug that is highly protein bound may cause increased free concentrations of the other drug, potentially resulting in adverse reactions. USE IN SPECIFIC POPULATIONS: Pregnancy Teratogenic Effects, Pregnancy Category C In animal reproduction studies, duloxetine has been shown to have adverse effects on embryo/ fetal and postnatal development. When duloxetine was administered orally to pregnant rats and rabbits during the period of organogenesis, there was no evidence of teratogenicity at doses up to 45 mg/kg/day (7 times the maximum recommended human dose [MRHD, 60 mg/day] and 4 times the human dose of 120 mg/day on a mg/m 2 basis, in rat; 15 times the MRHD and 7 times the human dose of 120 mg/day on a mg/m 2 basis in rabbit). However, fetal weights were decreased at this dose, with a no-effect dose of 10 mg/kg/day (2 times the MRHD and 1 times the human dose of 120 mg/day on a mg/m 2 basis in rat; 3 times the MRHD and 2 times the human dose of 120 mg/day on a mg/m 2 basis in rabbits). When duloxetine was administered orally to pregnant rats throughout gestation and lactation, the survival of pups to 1 day postpartum and pup body weights at birth and during the lactation period were decreased at a dose of 30 mg/kg/day (5 times the MRHD and 2 times the human dose of 120 mg/day on a mg/m 2 basis); the no-effect dose was 10 mg/kg/day. Furthermore, behaviors consistent with increased reactivity, such as increased startle response to noise and decreased habituation of locomotor activity, were observed in pups following maternal exposure to 30 mg/kg/day. Post-weaning growth and reproductive performance of the progeny were not affected adversely by maternal duloxetine treatment. There are no adequate and well-controlled studies in pregnant women; therefore, duloxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Neonates exposed to SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs), late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions]. When treating pregnant women with Cymbalta during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering Cymbalta in the third trimester. Labor and Delivery The effect of duloxetine on labor and delivery in humans is unknown. Duloxetine should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Duloxetine is excreted into the milk of lactating women. The estimated daily infant dose on a mg/kg basis is approximately 0.14% of the maternal dose. Because the safety of duloxetine in infants is not known, nursing while on Cymbalta is not recommended. However, if the physician determines that the benefit of duloxetine therapy for the mother outweighs any potential risk to the infant, no dosage adjustment is required as lactation did not influence duloxetine pharmacokinetics. Pediatric Use Safety and effectiveness in the pediatric population have not been established [see Boxed Warning and Warnings and Precautions]. Anyone considering the use of Cymbalta in a child or adolescent must balance the potential risks with the clinical need. Geriatric Use Of the 2,418 patients in premarketing clinical studies of Cymbalta for MDD, 5.9% (143) were 65 years of age or over. Of the 1,074 patients in the DPNP premarketing studies, 33% (357) were 65 years of age or over. Of the 1,761 patients in FM premarketing studies, 7.9% (140) were 65 years of age or over. Premarketing clinical studies of GAD did not include sufficient numbers of subjects age 65 or over to determine whether they respond differently from younger subjects. In the MDD and DPNP studies, no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. SSRIs and SNRIs, including Cymbalta have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see Warnings and Precautions]. Gender The half-life of duloxetine is similar in men and women. Dosage adjustment based on gender is not necessary. Smoking Status Duloxetine bioavailability (AUC) appears to be reduced by about one-third in smokers. Dosage modifications are not recommended for smokers. Race No specific pharmacokinetic study was conducted to investigate the effects of race. Hepatic Insufficiency [see Warnings and Precautions]. Severe Renal Impairment [see Warnings and Precautions]. DRUG ABUSE AND DEPENDENCE: Abuse In animal studies, duloxetine did not demonstrate barbiturate-like (depressant) abuse potential. While Cymbalta has not been systematically studied in humans for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials. However, it is not possible to predict on the basis of premarketing experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of Cymbalta (e.g., development of tolerance, incrementation of dose, drug-seeking behavior). Dependence In drug dependence studies, duloxetine did not demonstrate dependence producing potential in rats. OVERDOSAGE: Signs and Symptoms In postmarketing experience, fatal outcomes have been reported for acute overdoses, primarily with mixed overdoses, but also with duloxetine only, at doses as low as 1000 mg. Signs and symptoms of overdose (duloxetine alone or with mixed drugs) included somnolence, coma, serotonin syndrome, seizures, syncope, tachycardia, hypotension, hypertension, and vomiting. Management of Overdose There is no specific antidote to Cymbalta, but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered. In case of acute overdose, treatment should consist of those general measures employed in the management of overdose with any drug. NONCLINICAL TOXICOLOGY: Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenesis Duloxetine was administered in the diet to mice and rats for 2 years. In female mice receiving duloxetine at 140 mg/kg/day (11 times the maximum recommended human dose [MRHD, 60 mg/day] and 6 times the human dose of 120 mg/day on a mg/m 2 basis), there was an increased incidence of hepatocellular adenomas and carcinomas. The no-effect dose was 50 mg/kg/day (4 times the MRHD and 2 times the human dose of 120 mg/day on a mg/m 2 basis). Tumor incidence was not increased in male mice receiving duloxetine at doses up to 100 mg/kg/day (8 times the MRHD and 4 times the human dose of 120 mg/day on a mg/m 2 basis). In rats, dietary doses of duloxetine up to 27 mg/kg/day in females (4 times the MRHD and 2 times the human dose of 120 mg/day on a mg/m 2 basis) and up to 36 mg/kg/day in males (6 times the MRHD and 3 times the human dose of 120 mg/day on a mg/m 2 basis) did not increase the incidence of tumors. Mutagenesis Duloxetine was not mutagenic in the in vitro bacterial reverse mutation assay (Ames test) and was not clastogenic in an in vivo chromosomal aberration test in mouse bone marrow cells. Additionally, duloxetine was not genotoxic in an in vitro mammalian forward gene mutation assay in mouse lymphoma cells or in an in vitro unscheduled DNA synthesis (UDS) assay in primary rat hepatocytes, and did not induce sister chromatid exchange in Chinese hamster bone marrow in vivo. Impairment of Fertility Duloxetine administered orally to either male or female rats prior to and throughout mating at doses up to 45 mg/kg/day (7 times the maximum recommended human dose of 60 mg/day and 4 times the human dose of 120 mg/day on a mg/m 2 basis) did not alter mating or fertility. PATIENT COUNSELING INFORMATION: See FDA-approved Medication Guide and Patient Counseling Information section of full PI. Literature revised August, 11, 2008 PV 5909 AMP PRINTED IN USA Eli Lilly and Company Indianapolis, IN 46285, USA Copyright 2008, Eli Lilly and Company. All rights reserved. Cymbalta (duloxetine hydrochloride) PV 5909 AMP Cymbalta (duloxetine hydrochloride) PV 5909 AMP

8 Relax, we ve got painful muscle spasm under control. To learn more about AMRIX, visit booth 312. Once-daily AMRIX the proven efficacy of cyclobenzaprine with low rates of somnolence. 1 AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules) is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion. AMRIX should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. AMRIX has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy. AMRIX is contraindicated in patients who are hypersensitive to any of its components. AMRIX is contraindicated with concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation. AMRIX may have life-threatening interactions with MAO inhibitors. AMRIX is contraindicated during the acute recovery phase of myocardial infarction; in patients with arrhythmias, heart block conduction disturbances, or congestive heart failure; or in patients with hyperthyroidism. AMRIX may enhance the effects of alcohol, barbiturates, and other CNS depressants. AMRIX should not be used in elderly patients or in patients with impaired hepatic function. In clinical trials, the most commonly reported adverse reactions ( 3%) with AMRIX were dry mouth, dizziness, fatigue, nausea, dyspepsia, and constipation. Please see brief summary of full prescribing information on the following page. Reference: 1. Data on file. Studies 1105 and Cephalon, Inc.; For more information about AMRIX, call Cephalon Medical Services at 2008 Cephalon, Inc. All rights reserved. AMR139 May 2008 Printed in USA. AMRIX is produced with Eurand Diffucaps technology or visit

9 AMRIX Rx Only (Cyclobenzaprine Hydrochloride Extended-Release Capsules) Brief Summary of Prescribing Information. The following is a brief summary only. Please see full Prescribing Information for complete product information. DESCRIPTION AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules) is a skeletal muscle relaxant which relieves muscle spasm of local origin without interfering with muscle function. The active ingredient in AMRIX extended-release capsules is cyclobenzaprine hydrochloride, USP. AMRIX extended-release capsules for oral administration are supplied in 15 and 30 mg strengths. INDICATIONS AND USAGE AMRIX is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion. AMRIX should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. AMRIX has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy. CONTRAINDICATIONS Hypersensitivity to any component of this product. Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation. Hyperpyretic crisis seizures and deaths have occurred in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitor drugs. During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block conduction disturbances, or congestive heart failure. Hyperthyroidism. WARNINGS AMRIX is closely related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. In short term studies for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm, some of the more serious central nervous system reactions noted with the tricyclic antidepressants have occurred (see WARNINGS, below, and ADVERSE REACTIONS section of full Prescribing Information). Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. AMRIX may enhance the effects of alcohol, barbiturates, and other CNS depressants. As a result of a two-fold higher cyclobenzaprine plasma levels in subjects with mild hepatic impairment, as compared to healthy subjects, following administration of immediate-release cyclobenzaprine and because there is limited dosing flexibility with AMRIX, use of AMRIX is not recommended in subjects with mild, moderate or severe hepatic impairment. As a result of a 40% increase in cyclobenzaprine plasma levels and a 56% increase in plasma halflife following administration of AMRIX in elderly subjects as compared to young adults, use of AMRIX is not recommended in elderly. PRECAUTIONS General Because of its atropine-like action, AMRIX should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication. Information for Patients AMRIX, especially when used with alcohol or other CNS depressants, may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Drug Interactions AMRIX may have life-threatening interactions with MAO inhibitors. (See CONTRAINDICATIONS.) AMRIX may enhance the effects of alcohol, barbiturates, and other CNS depressants. Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds. Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol (ULTRAM [tramadol HCl tablets, Ortho-McNeil Pharmaceutical] or ULTRACET [tramadol HCl and acetaminophen tablets, Ortho-McNeil Pharmaceutical]). Carcinogenesis, Mutagenesis, Impairment of Fertility In rats treated with cyclobenzaprine for up to 67 weeks at doses of approximately 5 to 40 times the maximum recommended human dose, pale, sometimes enlarged, livers were noted and there was a dose-related hepatocyte vacuolation with lipidosis. Cyclobenzaprine did not affect the onset, incidence, or distribution of neoplasia in an 81-week study in the mouse or in a 105-week study in the rat. At oral doses of up to 10 times the human dose, cyclobenzaprine did not adversely affect the reproductive performance or fertility of male or female rats. A battery of mutagenicity tests using bacterial and mammalian systems for point mutations and cytogenic effects have provided no evidence for a mutagenic potential for cyclobenzaprine. Pregnancy Pregnancy Category B: Reproduction studies have been performed in rats, mice, and rabbits at doses up to 20 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cyclobenzaprine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because cyclobenzaprine is closely related to the tricyclic antidepressants, some of which are known to be excreted in human milk, caution should be exercised when AMRIX is administered to a nursing woman. Pediatric Use Safety and effectiveness of AMRIX has not been studied in pediatric patients. Use in the Elderly The plasma concentration and half-life of cyclobenzaprine are substantially increased in the elderly when compared to the general patient population (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations, Elderly in full Prescribing Information). Accordingly, AMRIX should not be used in the elderly. ADVERSE REACTIONS The most common adverse reactions in the two 14-day clinical efficacy trials are presented in Table 1. Table 1: Incidence of the Most Common Adverse Reactions Occurring in >_ 3% of Subjects in Any Treatment Group in the Two Phase 3, Double-Blind AMRIX Trials In a postmarketing surveillance program (7607 patients treated with cyclobenzaprine 10 mg TID), the adverse reactions reported most frequently were drowsiness, dry mouth, and dizziness. Among the less frequent adverse reactions, there was no appreciable difference in incidence in controlled clinical studies or in the surveillance program. Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion. The following adverse reactions have been reported in post-marketing experience or with an incidence of less than 1% of patients in clinical trials with the 10 mg TID tablet: Body as a Whole: Syncope; malaise. Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension. Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice, and cholestasis. Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash. Musculoskeletal: Local weakness. Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia. Skin: Sweating. Special Senses: Ageusia; tinnitus. Urogenital: Urinary frequency and/or retention. DRUG ABUSE AND DEPENDENCE Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules) is administered, even though they have not been reported to occur with this drug. Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise. These are not indicative of addiction. OVERDOSAGE Although rare, deaths may occur from overdosage with AMRIX. Multiple drug ingestion (including alcohol) is common in deliberate cyclobenzaprine overdose. As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity may develop rapidly after cyclobenzaprine overdose; therefore, hospital monitoring is required as soon as possible. All patients suspected of an overdose with AMRIX should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage and emesis is contraindicated. The principles of management of child and adult overdosage are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment. DOSAGE AND ADMINISTRATION The recommended adult dose for most patients is one (1) AMRIX 15 mg capsule taken once daily. Some patients may require up to 30 mg/day, given as one (1) AMRIX 30 mg capsule taken once daily or as two (2) AMRIX 15 mg capsules taken once daily. It is recommended that doses be taken at approximately the same time each day. Use of AMRIX for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE). Dosage Considerations for Special Patient Populations: AMRIX should not be used in the elderly or in patients with impaired hepatic function (see WARNINGS). HOW SUPPLIED AMRIX extended-release capsules are available in 15 and 30 mg strengths, packaged in bottles of 60 capsules. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Distributed by Cephalon, Inc., Frazer, PA Manufactured by Eurand, Inc., Vandalia, Ohio AMRIX is a trademark of Cephalon, Inc., or its affiliates. 2004, 2006, 2007 Cephalon, Inc., or its affiliates. All rights reserved. AMR002a Rev. 4/2008

10 ANS is proud to announce we are changing our name to St. Jude Medical. As the Neuromodulation Division of St. Jude Medical, we remain exclusively focused on developing innovative products for the treatment of chronic pain and other neurological disorders. Our goal is to reduce risk by continuously finding ways to put more control into the hands of physicians who treat these conditions. With access to more resources than ever before, we are equipped to accelerate our therapy access, clinical education and research efforts, expand indications and provide unparalleled fi eld support. Experience Control. AAPM booth 604 sjmneuro.com ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are trademarks and service marks of St. Jude Medical, Inc. and its related companies St. Jude Medical. All Rights Reserved.

11 AAPM 25th Annual Meeting Contents General Information Welcome Board of Directors/Program Committee Committees/Liaisons Council of Past Presidents Program Information Evaluations AAPM Awards Past Award Recipients Hilton Hawaiian Village Map Hotel Floor Plan th Annual Meeting Supporters Schedule of Events Schedule at a Glance Preconference Sessions Plenary Sessions Concurrent Scientific Sessions Interventional Track Integrative Track International Track AAPM Faculty List and Disclosures Satellite Symposia Exhibits Exhibit Hall Floor Plan Exhibit Schedule List of Exhibitors List of Exhibitors (by category) Exhibitors Corporate Members Index of Advertisers Alpharma Cephalon, Inc....6, 7, 75, 76, Inside Back Cover, Back Cover Eli Lilly & Company... 1, 2, 3, 4, 5 Emerging Solutions in Pain Endo Pharmaceuticals, Inc... Inside Front Cover King Pharmaceuticals St. Jude Medical Center

12 the American Academy of Pain Medicine 25th Annual Meeting WELCOME RECEPTION Attendees of the 25th Annual Meeting are cordially invited for refreshments, hors d oeuvres, and an opportunity to converse with colleagues at the Welcome Reception, hosted by the American Academy of Pain Medicine. Join us in the AAPM Exhibit Hall, located in the Coral Ballroom at the Hilton Hawaiian Village. Wednesday, January :30 pm 10

13 Welcome! American Academy of Pain Medicine 25th Annual Meeting As cochairs of the AAPM s Annual Meeting Committee, we would like to extend an aloha to all attendees and give you a taste of what our 25th Annual Meeting has in store for you. This year s meeting is special, not only because it s our 25th anniversary and not only because it s in Hawaii, but also because it boasts such an outstanding array of sessions, many with an international flavor. This year s keynote address, Neuroplasticity and Chronic Pain, will be delivered by Norman Doidge, MD PhD DSc, who will discuss the transformational principles behind the science of brain regeneration. Author of the New York Times best-seller The Brain That Changes Itself: Stories of Personal Triumph from the Frontiers of Brain Science, Dr. Doidge is a member of the research faculty at Columbia University and the University of Toronto s Department of Psychiatry. He will address neuroplasticity s implications for patients suffering from chronic pain through the fascinating discovery that the human brain is a changeable organ that can alter its own structure and function. We are excited that he has agreed to join us and look forward to what he has to share with our members. Among the other international highlights of this year s Annual Meeting are plenary sessions: Acupuncture: Historical Perspectives and Emerging Advances in the Treatment of Pain and Addiction by Jisheng Han, MD, of the Neuroscience Research Institute at Peking University in Beijing, China; and The Loneliness of Science in Interventional Pain Medicine by Nikolai Bogduk, MD PhD, of the Newcastle Bone and Joint Institution at Royal Newcastle Hospital in New South Wales, Australia. As always, the Committee has planned plenary sessions on the most emerging issues in Pain Medicine. This year s focus is on two of the most topical: war-related pain and elder pain. WAR and PAIN: From Battlefield to Back Home will be presented by Chester Trip Buckenmaier, III, MD COL MC, of the Uniformed Services University of the Health Sciences in Bethesda, MD, and R. Norman Harden, MD, of Northwestern s School of Medicine and the Center for Pain Studies at the Rehabilitation Institute of Chicago. Pain Medicine in Older Adults: Preparing for a Paradigm Shift will be presented by Debra K. Weiner, MD, director of the Older Adult Pain Management Program at the University of Pittsburgh Medical Center. In addition, this year s scientific sessions have been consolidated into three tracks interventional, integrative, and international that boast an outstanding array of speakers and sessions that we are sure will enhance your skills and knowledge and make you a better Pain Medicine physician. The interventional track offers the latest on electrical neuromodulation, surgical versus percutaneous treatment approaches to low-back pain, cervical spinal injections, and headache disorders, among others. The integrative track, on the other hand, offers the latest on managing chronic pain populations, regaining the trust of inherited pain patients, and Pain Medicine malpractice, among others. Finally, the international track will present advances and perspectives on Pain Medicine through a global scope. Our 2-day Essentials of Pain Medicine program, which kicks off the 25th Annual Meeting, is also back by popular demand. Among the topics covered in this course are pharmacological interventional and rehabilitation techniques for the treatment of chronic pain, appropriate prescribing patterns for opioid and non-opioid use, and legal and ethical issues surrounding pain management. Two additional preconference sessions Ultrasound Guidance for the Pain Physician and Opioid Therapy: Cutting-Edge Scientific Approaches and Practical Strategies offer great opportunities to learn new skills or update existing knowledge. All the other extras that have made the Annual Meeting so worthwhile are also back this year, including the welcome reception; breakfast, lunch, and dinner symposia; the exhibit hall; and a variety of other informative educational sessions, such as plenary research updates and a plenary panel discussion of The Art of Pain Medicine: When Needles and Drugs Don t Work. We are delighted that you have joined us in Hawaii! We know that you will enjoy your experience, we trust that you will find the sessions professionally stimulating, and we are sure you will take full advantage of all the wonderful opportunities available to you in this tropical paradise. Perry G. Fine, MD B. Todd Sitzman, MD MPH 2009 AAPM 25th Annual Meeting Committee Cochairs 11

14 Board of Directors/Program Committee Board of Directors President Kenneth A. Follett, MD PhD President-Elect Rollin M. Gallagher, MD MPH Treasurer Perry G. Fine, MD Secretary Eduardo Fraifeld, MD Immediate Past President B. Todd Sitzman, MD MPH Directors-at-Large Zahid H. Bajwa, MD Donna M. Bloodworth, MD Timothy R. Deer, MD Bill H. McCarberg, MD Richard K. Osenbach, MD Jerome Schofferman, MD Lynn R. Webster, MD ABPM Liaison Director Michel Y. Dubois, MD Editor-in-Chief (Pain Medicine) Rollin M. Gallagher, MD MPH Executive Medical Director Philipp M. Lippe, MD Representative of Past Presidents E. Richard Blonsky, MD 2009 Program Committee Conference Cochairs Perry G. Fine, MD Professor Anesthesiology Pain Research Center University of Utah School of Medicine Salt Lake City, UT B. Todd Sitzman, MD MPH Director Advanced Pain Therapy Forrest General Cancer Center Hattiesburg, MS Essentials of Pain Medicine TM Cochairs Zahid H. Bajwa, MD Assistant Professor Department of Anesthesia and Neurology Harvard Medical School Director Education and Clinical Pain Research Beth Israel Deaconess Medical Center Boston, MA Bill H. McCarberg, MD Chronic Pain Management Program Kaiser Permanente Escondido, CA Scientific Poster Session Chair Jeffrey M. Tiede, MD Columbia Interventional Pain Center Columbia, MO Committee Members Donna M. Bloodworth, MD Associate Professor Department of Physical Medicine and Rehabilitation Quentin Mease Community Hospital Houston, TX Nancy C. Bratanow, MD Clinical Director, CEO Midwest Comprehensive Pain Care Milwaukee, WI Michael Byas-Smith, MD Associate Professor Emory University and Hospital Atlanta, GA Paul Christo, MD MBA Assistant Professor Director Multidisciplinary Pain Fellowship Director Pain Treatment Center Department of Anesthesiology and Critical Care Medicine Division of Pain Medicine Johns Hopkins University School of Medicine Baltimore, MD Robert I. Cohen, MD Assistant Professor Anesthesiology Beth Israel Hospital Arnold Pain Management Center Boston, MA Geralyn Datz, PhD Director Pain Management Program Psychology Services Forrest General Hospital Hattiesburg, MS Timothy R. Deer, MD President and CEO Center for Pain Relief Charleston, WV Larry C. Driver, MD Adjunct Ethicist Clinical Ethics, Anesthesiology, and Pain Medicine M. D. Anderson Cancer Center Consultant University of Texas Houston, TX 12

15 Program Committee Douglas Gourlay, MD FRCP Wasser Pain Management Centre Mt. Sinai Hospital Waterdown, ON, Canada Howard A. Heit, MD FACP FASAM Assistant Clinical Professor Georgetown School of Medicine Georgetown University Fairfax, VA Marc Huntoon, MD Anesthesiology/Pain Medicine Mayo Clinic Rochester, MN Leonardo Kapural, MD PhD Interventional Track Section Head Pain Management Department Cleveland Clinic Foundation Cleveland, OH Diane M. Keaney, MSN RN CNS Clinical Nurse Specialist Bay Area Pain Medical Associates Mill Valley, CA Gagan Mahajan, MD Associate Professor Anesthesiology and Pain Medicine University of California Davis School of Medicine Sacramento, CA Michael H. Moskowitz, MD MPH Adjunct Professor University of California Davis School of Medicine Bay Area Pain Medical Associates Mill Valley, CA James Rathmell, MD Director MGH Pain Center Massachusetts General Hospital Boston, MA Steven Richeimer, MD Director Pain Center University of Southern California Los Angeles, CA Jerome Schofferman, MD SpineCare Medical Group, Inc. Daly City, CA Steven P. Stanos, DO Assistant Professor Department of Physical Medicine and Rehabilitation Northwestern University Feinburg School of Medicine Medical Director Center for Pain Management Rehabilitation Institute of Chicago Chicago, IL Ajay D. Wasan, MD MSc Integrative Track Section Head Anesthesiology and Psychiatry Pain Management Center Harvard Medical School Brigham and Women s Hospital Chestnut Hill, MA Lynn R. Webster, MD FACPM Medical Director Lifetree Pain Clinic Salt Lake City, UT Way Yin, MD Advisor Interventional Medical Associates of Bellingham PC Bellingham, WA International Advisors United States Michel Y. Dubois, MD President American Board of Pain Medicine Director Research and Education Professor Clinical Anesthesiology New York University School of Medicine New York, NY Scott M. Fishman, MD Chief Division of Pain Medicine Department of Anesthesiology and Pain Medicine University of California Davis School of Medicine Lawrence J. Ellison Ambulatory Care Center Sacramento, CA Rollin M. Gallagher, MD MPH Director Pain Medicine Service Philadelphia Veterans Affairs Medical Center Director Pain Policy Research and Primary Care Penn Pain Medicine Clinical Professor Psychiatry and Anesthesiology University of Pennsylvania School of Medicine Philadelphia, PA China Jisheng Han, MD Member Chinese Academy of Sciences Director Neuroscience Research Institute Professor Physiology Peking University Beijing, China De Ren Zhang, MD Director Pain Medicine Services CEO NanShan Hospital Shenzhen, China Australia Nikolai Bogduk, MD PhD Department of Clinical Research Newcastle Bone and Joint Institution Royal Newcastle Hospital Newcastle, New South Wales, Australia Michael Cousins, MD DSc FANZCA FRCA FAChPM(RACP) FFPMANZCA University of Sydney at Royal North Shore Hospital Pain Management Research Institute St. Leonards, Sydney, Australia C. Roger Goucke, MB ChB DTM&H FANZCA FFPMANCZA FAChPM Director Pain Management Department Sir Charles Gairdner Hospital Nedlands, Western Australia, Australia 13

16 Committees/Liaisons American Medical Association Delegation Philipp M. Lippe, MD (Delegate) Albert Ray, MD (Alternate Delegate) Awards Committee B. Todd Sitzman, MD MPH (Chair) Scott M. Fishman, MD Kenneth Follett, MD PhD Rollin M. Gallagher, MD MPH Business Oversight Committee B. Todd Sitzman, MD MPH (Chair) Perry G. Fine, MD Scott M. Fishman, MD Kenneth Follett, MD PhD Melvin Gitlin, MD Tim J. Lamer, MD Benson Munger, PhD Albert Ray, MD Richard Stieg, MD By-Laws Committee Michel Y. Dubois, MD (Chair) Frederick W. Burgess, MD PhD Philipp M. Lippe, MD Albert Ray, MD Ben Shwachman, MD JD CME Committee Richard Osenbach, MD (Chair) Donna M. Bloodworth, MD Bernard Canlas, MD Gerhard Friehs, MD Coding and Reimbursement Committee Eduardo Fraifeld, MD (Chair) Paul Christo, MD Fred Davis, MD Todd Handel, MD Frank Lagattuta, MD Srdjan Nedeljkovic, MD Gunasiri Samarasinghe, MD Ben Shwachman, MD JD Lee Snook, MD Leonard Soloniuk, MD Emily Hill (Counsel) Communications Committee Frederick W. Burgess, MD PhD (Chair) Robert L. Barkin, PharmD Michael Francis, MD Lynn Johnson, MD Michael Moskowitz, MD MPH Sunil Panchal, MD John Peppin, DO FACP Educational Programs Committee Vitaly Gordin, MD (Chair) Donna M. Bloodworth, MD Edwin L. Capulong, MD Robert Cohen, MD Juan B. Firnhaber-Burgos, MD Rollin M. Gallagher, MD MPH David Giampetro, MD Michael Moskowitz, MD MPH Dana L. Simon, MD Marc Sloan, MD Ethics Committee Michel Y. Dubois, MD (Chair) John Banja, PhD David Brushwood, JD RPh Timothy R. Deer, MD Larry C. Driver, MD Gilbert Fanciullo, MD Perry G. Fine, MD Rollin M. Gallagher, MD MPH Hugh Gilbert, MD Daniel Hamaty, MD Lynn Jansen, PhD RN Allen Lebovits, PhD Philipp M. Lippe, MD Robert Orr, MD John Peppin, DO FACP Ben Rich, JD PhD Jerome Schofferman, MD Knoz Todd, MD Jennifer Bolen, JD External Affairs Committee Norman Marcus, MD (Chair) Benoy Benny, MD Paul Christo, MD MBA Dave Columbus, DO Timothy R. Deer, MD Orlando Florete, MD Gerhard Friehs, MD Rollin M. Gallagher, MD MPH Martin Grabois, MD J. David Haddox, DDS MD Salim Hayek, MD Edwin Hyde, MD Margaret M. Kotz, DO Philipp M. Lippe, MD Paul E. Mayes, MD Edward Michna, JD MD John Peppin, DO FACP Joshua P. Prager, MD Albert Ray, MD Richard Rosenquist, MD David P. Russo, DO MPH MS Ben Shwachman, MD JD Michael Weintraub, MD 14

17 Committees/Liaisons Finance Committee Perry G. Fine, MD (Chair) Kenneth Follett, MD PhD Rollin M. Gallagher, MD MPH Melvin Gitlin, MD Philipp M. Lippe, MD Sunil Panchal, MD B. Todd Sitzman, MD MPH Legislative and Regulatory Affairs Committee Scott M. Fishman, MD (Chair) Eduardo Fraifeld, MD Rollin M. Gallagher, MD MPH Ben Rich, JD PhD B. Todd Sitzman, MD MPH Jennifer Bolen, JD (Counsel) Membership Committee Thomas L. Yearwood, MD PhD (Chair) Frederick W. Burgess, MD PhD Geralyn Datz, PhD Todd Handel, MD Mark F. Hurdle, MD Paul Kreis, MD Lisa Nocera, MD Khuram Sial, MD Howard S. Smith, MD Scott Tackett, PA-C Nominating Committee B. Todd Sitzman, MD MPH (Chair) Kenneth Follett, MD PhD Rollin M. Gallagher, MD MPH Leonardo Kapural, MD PhD Philipp M. Lippe, MD Joshua P. Prager, MD Scientific Poster Abstract Committee Jeffrey M. Tiede, MD (Chair) Donna M. Bloodworth, MD Nancy C. Bratanow, MD Rollin M. Gallagher, MD MPH Gennady Gekht, MD Leonardo Kapural, MD PhD Ajay D. Wasan, MD Toby Weingarten, MD Scientific Membership Subcommittee Thomas L. Yearwood, MD PhD Dan Doleys, PhD Rollin M. Gallagher, MD MPH Allen Lebovits, PhD Scientific Review Committee Timothy R. Deer, MD (Chair) Zahid H. Bajwa, MD David Borsook, MD PhD Mohamed Elkersh, MD Vitaly Gordin, MD Howard Heit, MD FACP Robin Hamill-Ruth, MD Leonardo Kapural, MD PhD Nagy Mekhail, MD PhD Richard Osenbach, MD Sunil Panchal, MD Jerome Schofferman, MD Sridhar Vasudevan, MD Thomas L. Yearwood, MD PhD Site Selection Task Force Donna M. Bloodworth, MD (Chair) Martin Grabois, MD Sunil Panchal, MD Strategic Planning Committee Rollin M. Gallagher, MD MPH (Chair) E. Richard Blonsky, MD Frederick W. Burgess, MD PhD Michel Y. Dubois, MD Perry G. Fine, MD Kenneth Follett, MD PhD Eduardo Fraifeld, MD Vitaly Gordin, MD J. David Haddox, DDS MD Philipp M. Lippe, MD Michael Moskowitz, MD MPH B. Todd Sitzman, MD, MPH Thomas L. Yearwood, MD PhD Council of Past Presidents 1985 Benjamin L. Crue, Jr., MD FACS 1986 Joel L. Seres, MD 1987 Robert G. Addison, MD 1988 Philipp M. Lippe, MD 1989 Jack J. Pinsky, MD 1990 Andrew G. Shetter, MD 1991 Sridhar V. Vasudevan, MD 1992 E. Richard Blonsky, MD (Board Liaison) 1993 Peter R. Wilson, PhD MBBS 1994 Richard L. Stieg, MD 1995 Hubert L. Rosomoff, MD DMedSc FAAPM 1996 Steven D. Feinberg, MD 1997 Gerald M. Aronoff, MD 1998 J. David Haddox, DDS MD (Vice-Chair) 1999 Norman J. Marcus, MD 2000 Edward C. Covington, MD 2001 Albert Ray, MD 2002 Marc B. Hahn, DO 2003 Melvin C. Gitlin, MD (Chair) 2004 Samuel J. Hassenbusch, MD PhD 2005 Scott M. Fishman, MD 2006 Frederick W. Burgess, MD PhD 2007 B. Todd Sitzman, MD MPH 15

18 Program Information Schedule of Events Please note that the schedule of events included in this program book was current at the time of publication and includes several program changes that have occurred since the mailing of the meeting brochure. Please check the day-at-a-glance schedule, available at the registration desk, for room locations and any last-minute program changes. Objectives After attending this meeting, participants should be better able to assess, diagnose, and evaluate patients with a variety of acute and chronic pain disorders develop appropriate treatment and rehabilitation plans for patients with acute and chronic pain, and identify when to refer patients identify and treat addiction evaluate new trends, therapies, techniques, and diagnostic procedures in pain management identify the indications, contraindications, and complications for established techniques and therapies for the management of pain evaluate and treat various sleep disorders in patients with chronic pain evaluate and treat behavioral issues associated with chronic pain understand the legal and ethical issues surrounding pain management define strategies for providing multidisciplinary and interdisciplinary care for the patient with chronic pain identify informative professional and consumer-oriented Web sites dedicated to pain and its treatment. Disclosure It is the policy of the American Academy of Pain Medicine (AAPM) to plan and implement educational activities in accordance with Accreditation Council for Continuing Medical Education (ACCME) Essential Areas and Elements, incorporating updated accreditation criteria, and revised commercial support standards to ensure balance, independence, objectivity, and scientific rigor. All program faculty and planners are required to disclose all financial relationships they may have or have had within the last 12 months with commercial interests whose products or services are related to the subject matter of the presentation. Any real or apparent conflicts of interest must be resolved prior to the presentation. Disclosure information will be made available to attendees at the meeting. Faculty will be expected to disclose this information to the audience both verbally and on printed introductory slides at the beginning of each presentation. Faculty members are also required to inform program participants if any unlabeled uses of products regulated by the U.S. Food and Drug Administration will be discussed. Continuing Medical Education Credits The AAPM is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to sponsor continuing medical education (CME) for physicians. Physicians should only claim credit commensurate with the extent of their participation in the activity. AAPM Annual Meeting Educational Sessions credits Preconference Sessions Essentials of Pain Medicine TM credits Ultrasound Guidance for the Pain Physician... 4 credits Opioid Therapy: Cutting-Edge Scientific Approaches and Practical Strategies credits Family Physicians The AAPM is approved by the American Academy of Family Physicians (AAFP) to offer continuing medical education for the 25th Annual Meeting. This activity has been reviewed and is acceptable for up to prescribed and 1.00 elective credits by the AAFP. Physician Assistants The American Academy of Physician Assistants (AAPA) accepts Category 1 CME credit from AOACCME, prescribed credit from AAFP, and AMA Category 1 CME credit for the PRA from organizations accredited by ACCME. Continuing Nursing Education The 25th Annual Meeting, Essentials of Pain Medicine and Opioid Therapy: Cutting Edge Scientific Approaches and Practical Strategies were approved for credit by the Association of Rehabilitation Nurses (ARN), an accredited approver by the American Nurses Credentialing Center s Commission on Accreditation. ARN Approval Code: AAPM ; number of nursing contact hours approved: How to Obtain CME Credit An evaluation form of the 25th Annual Meeting will be available online to each registrant. To receive CME credit for each session you attend, you must evaluate that session in the appropriate section of the online evaluation. You will be able to print your certificate once you complete the evaluation. Commercially Supported Satellite Symposia Satellite symposia will be offered during breakfast, lunch, and dinner hours during the preconference and Annual Meeting session. These independently managed satellite symposia are supported by the AAPM s corporate members. The programs have been reviewed by the AAPM Program Committee and approved for presentation as part of the Commercial Satellite Symposia program. These sessions are offered free of charge to all meeting registrants; however, those who have preregistered will be seated first. A limited number of seats will also be available on a firstcome, first-served basis. Check for availability at the registration desk outside the session room 30 minutes before the scheduled start of the program. 16

19 Evaluations Attendees will be asked to submit evaluations online for the 2009 Annual Meeting sessions. Please use the space provided to make any notes about the sessions you attend to assist you with the online evaluation form. Login information is provided to all Annual Meeting registrants. Essentials of Pain Medicine TM Tuesday, January 27, :15 am 5 pm Essentials of Pain Medicine TM : Day 1 Zahid H. Bajwa, MD; Bill H. McCarberg, MD; Larry C. Driver, MD; Scott M. Fishman, MD; Paul Kreis, MD; Michael H. Moskowitz, MD MPH Wednesday, January 28, :30 am 5:15 pm Essentials of Pain Medicine TM : Day 2 Charles E. Argoff, MD; Zahid H. Bajwa, MD; Bill H. McCarberg, MD; Paul Kreis, MD; Gagan Mahajan, MD; Steven P. Stanos, DO Preconference Sessions Tuesday, January 27, pm Preconference Session (001) Ultrasound Guidance for the Pain Physician Mark F. Hurdle, MD; Adam K. Jacob, MD; Steven J. Wisniewski, MD Wednesday, January 28, :30 am 4:45 pm Preconference Session (002) Opioid Therapy: Cutting-Edge Scientific Approaches and Practical Strategies Perry G. Fine, MD; Scott M. Fishman, MD; Rollin M. Gallagher, MD MPH; Howard A. Heit, MD FACP FASAM; Edward Michna, MD; Michael H. Moskowitz, MD MPH; Ajay D. Wasan, MD MSc; Lynn R. Webster, MD FACPM 17

20 Evaluations 2009 Annual Meeting Sessions Wednesday, January 28, 2009 Plenary Session (112) 6 7:15 am Intrathecal Therapies for Chronic Pain: Old Challenges and New Developments Timothy R. Deer, MD; Leonardo Kapural, MD PhD; B. Todd Sitzman, MD MPH Thursday, January 29, am Plenary Session (101) Neuroplasticity and Chronic Pain Norman Doidge, MD PhD DSc 8 8:30 am Plenary Session (102) Plenary Research Highlights Marek Kurowski, MD; Joel Saper, MD; Ajay D. Wasan, MD MSc 10 10:40 am Plenary Session (104) American Medical Association Address: Quality Patient Care J. James Rohack, MD 12:45 1:45 pm Electrical Neuromodulation: Justifying the Cost of Spinal-Cord Stimulation (201) Richard B. North, MD; Jane B. Shipley, BA NF 18

21 Evaluations 2009 Annual Meeting Sessions2:45 1:45 pm 12:45 1:45 pm Management of Chronic Pain Populations: Community, V.A., Managed Care, and Rural Approaches (202) Rollin M. Gallagher, MD MPH; Fred N. Davis, MD; Bill H. McCarberg, MD; B. Todd Sitzman, MD MPH 2:30 3:30 pm Treatment Approaches to Discogenic Low-Back Pain: Surgical Versus Percutaneous (203) Leonardo Kapural, MD PhD; Craig Meyer, MD; Jeffrey M. Tiede, MD 2:30 3:30 pm Pain Medicine Malpractice: Areas of Inquiry and Legal Updates (204) Rollin M. Gallagher, MD MPH; Ben Rich, PhD JD Friday, January 30, :15 8:15 am Plenary Session (105) The Loneliness of Science in Interventional Pain Medicine Nikolai Bogduk, MD PhD Dsc 8:15 9 am Plenary Session (106) Plenary Research Highlights Colin S. Goodchild, MD PhD; Tae Kyun Kim, MD PhD; Jeffrey M. Tiede, MD 19

22 Evaluations 2009 Annual Meeting Sessions (cont.) am Plenary Session (107) Acupuncture: Historical Perspectives and Emerging Advances in the Treatment of Pain and Addiction Jisheng Han, MD 12:45 1:45 pm Cervical Spinal Injections: Significant Complications and Recommendations to Improve Safety (301) Anthony H. Guarino, MD; Marc Huntoon, MD 12:45 1:45 pm Inheriting the Chronic Pain Patient: Breaking the Barriers and Regaining the Trust (302) Howard A. Heit, MD FACP FASAM; Douglas Gourlay, MD FRCP 12:45 1:45 pm Advances in Interventional Pain Management (305) Jisheng Han, MD; Lizu Xiao, MD; Bifa Fan, MD; Mark S. Wallace, MD 2 3 pm Sacroiliitis: Contemporary Approaches for the Treatment of the Chronic Pain in the Butt (303) Steven Cohen, MD; Paul Dreyfuss, MD; Leonardo Kapural, MD PhD 2 3 pm Neuropathic Pain: Clinical Evaluation and Examination Pearls for the Practicing Pain Clinician (304) Miroslav Backonja, MD; Mark S. Wallace, MD; Ajay D. Wasan, MD MSc 20

23 Evaluations 2009 Annual Meeting Sessions 2 3 pm Training of Future Pain Medicine Physicians: International Perspectives (306) Michel Y. Dubois, MD; Rollin M. Gallagher, MD MPH; You Wan, MD PhD 3:15 4:15 pm Plenary Session (113) Recent Advances in Complex Regional Pain Syndrome Anne Louise Oaklander, MD PhD; Joshua P. Prager, MD MS 4:15 5:15 pm Plenary Session (108) The Art of Pain Medicine: When Needles and Drugs Don t Work Perry G. Fine, MD; Norman Doidge, MD PhD DSc; Kenneth A. Follett, MD PhD; Leonardo Kapural, MD PhD; Michael H. Moskowitz, MD MPH Saturday, January 31, :30 am Plenary Session (109) Plenary Research Highlights Robert Edwards, PhD; Leonardo Kapural, MD PhD; Rosemary C. Polomano, PhD RN 8:30 9:30 am Plenary Session (110) Pain Medicine in Older Adults: Preparing for a Paradigm Shift Debra K. Weiner, MD 21

24 Evaluations 2009 Annual Meeting Sessions (cont.) am Plenary Session (111) WAR and PAIN: From Battlefield to Back Home Chester Buckenmaier III, MD COL MC; R. Norman Harden, MD 12:45 3 pm Comprehensive Headache Symposium: International Perspectives on the Management of Headache Disorders (401) Zahid H. Bajwa, MD; Robert M. Levy, MD PhD; Samer Narouze, MD MSc; Joel Saper, MD 12:45 1:45 pm East Versus West International Perspectives on the Management of Cancer Pain (402) Larry C. Driver, MD; C. Roger Goucke, MB ChB DTM&H FANZCA FFPMANCZA FAChPM; Steven D. Passik, PhD 2 3 pm Integrative Pain Care: Effective Management Through Multidisciplinary Collaboration (403) Diane M. Keaney, MSN RN CNS; Patricia W. Nishimoto, DNSc MPH RN ONS; Hob Osterlund, APRN CNS PCC 2 3 pm Mindfulness and Chronic Pain: A Practical Approach (404) Marcia Howton, MD; Michael J. Lewandowski, PhD; Michael H. Moskowitz, MD MPH 22

25 2009 AAPM Awards Philipp M. Lippe, MD, Award The Philipp M. Lippe, MD, Award is presented to a physician for outstanding contributions to the social and political aspects of Pain Medicine. Social and political accomplishments could be those that benefit the science, the practice, or the recognition of the specialty. Albert L. Ray, MD Albert L. Ray, MD, has been involved in the study and treatment of painful disorders for more than 32 years and has also actively supported the development of Pain Medicine as a specialty in the United States. Dr. Ray earned his medical degree from the New Jersey College of Medicine in Newark and is certified by the American Board of Pain Medicine and the American Board of Psychiatry and Neurology. He completed both an internship and a residency in psychiatry at Monmouth Medical Center in Long Branch, NJ, where he was chief resident. Dr. Ray has previously served on the board of directors of the Southeastern Branch of the National Arthritis Foundation and is past president of the AAPM and the Southern Pain Society and past director of the American Board of Pain Medicine. Currently, Dr. Ray is president of the Foundation for Pain Medicine and chairman of the board of the National Pain Foundation. He is also serving as medical director at Pain Medicine Solutions and clinical associate professor at the University of Miami School of Medicine in Florida. Dr. Ray has delivered lectures all across the United States as well as internationally. He is coauthor of a chapter in a pain management textbook, and he is an editorial reviewer for Pain Medicine. Other awards and honors Dr. Ray has received include the Nancy C. Roeske, MD, teaching award for Excellence in Medical Education from the American Psychiatric Society and the Distinguished Service Awards from the AAPM and the Southern Pain Society. In addition, Dr. Ray was listed among the Top 200 doctors in South Florida in

26 2009 AAPM Awards Founders Award The Founders Award is presented to an individual for outstanding contributions to the science or practice of Pain Medicine. This award is given for continued contributions to the basic or clinical science of Pain Medicine or for demonstration of clinical excellence or innovation in the practice of Pain Medicine. Nikolai Bogduk, MD PhD DSc Nikolai Bogduk, MD PhD DSc, currently holds positions as conjoint professor of Pain Medicine at the University of Newcastle and senior staff specialist at Royal Newcastle Centre. Dr. Bogduk is actively involved in the advancement of Pain Medicine through various professional organizations in Australia, including the Anatomical Society of Australia and New Zealand (past president), the Australian Association of Musculoskeletal Medicine (past president), the Australian Pain Society, the Australian Association of Neurologists, the Australian Headache Society, and the Spine Society of Australia. He belongs to international organizations such as the International Anatomical Nomenclature Committee, the International Association for the Study of Pain, the International Headache Society, and the International Spinal Injection Society, Inc. (past president). In addition to having participated on panels at the National Health and Medical Research Council and the Royal Australasian College of Surgeons, Dr. Bogduk serves on the editorials boards for Clinical Biomechanics, Spine, Cephalalgia, Pain Medicine, The Spine Journal, and European Spine Journal. A graduate of the University of Sydney and the University of New South Wales, Dr. Bogduk holds a bachelor degree of science (medicine), a bachelor degree of medicine, a doctor of philosophy degree in neurology, a doctor of medicine degree, and a doctor of science. He also earned the title of fellow at the Australasian Faculty of Rehabilitation Medicine, Royal Australasian College of Physicians; the Faculty of Pain Medicine, Australian and New Zealand College of Anaesthetists; and the Australasian Faculty of Musculoskeletal Medicine. In addition to his current positions at the University of Newcastle and Royal Newcastle Centre, Dr. Bogduk has held positions as lecturer and professor, among others, at the University of Queensland, the University of Sydney, and Repatriation General Hospital in Concord, New South Wales. He has been awarded more than $7.8 million (AUD) in research grants related to diagnosis, treatment, and guidelines in Pain Medicine. Dr. Bogduk s work has been published in the areas of lumbar spine and low-back pain; cervical spine, neck pain, and cervical headache; pathophysiology of migrane; cervical spine and shoulder; thoracic spine and shoulder; and others. His referred papers have earned such distinctions as the Volvo Award for Low Back Pain Research, the Inaugural Spinal Research Award, Outstanding Paper Award: Nonoperative Science, the Wagemacker Prize of the Federation International de Manuelle Medicine, Honourable Mention for the First Cervical Spine Research Society Award, and the Cervical Spine Research Society Prize. In addition to invited papers, editorials, and commentaries, Dr. Bogduk has authored or coauthored 6 monographs, 125 chapters to books, and 17 books. Since 1979, Dr. Bogduk has been invited to speak at various national and international conferences related to Pain Medicine. Recently, he was an invited speaker at the 10th International Conference of The McKenzie Institute International (March 2007), the 27th Annual Meeting of the Australian Pain Society (April 2007), and the 68th Annual Assembly of American Academy of Physical Medicine and Rehabilitation (September 2007). 24

27 2009 AAPM Awards Distinguished Service Award The Distinguished Service Award is presented to an individual for commitment and contributions to the American Academy of Pain Medicine. This award is given to an individual for specific outstanding contributions. Colleen M. Healy Serving as the managing editor of Pain Medicine, AAPM s journal, Colleen M. Healy has more than 20 years of experience as an office manager and 10 years as a managing editor and editorial assistant. As managing editor, Ms. Healy is responsible for submitting the contents for each issue to the publisher and reviewing page proofs for the contents and masthead of every issue. She manages the editorial process from recruiting authors, reviewing and editing submissions, tracking support funds, processing honoraria, and paying invoices for publishing costs. Ms. Healy also continues to perform tasks she was responsible for as editorial assistant, including sending out manuscripts to be peer reviewed and keeping track of the review process, sending manuscripts back to authors for revisions, assuring timely receipt of reviews and revised manuscripts, and sending out revised manuscripts for rereview. Additionally, Ms. Healy also obtained copyright agreement forms and maintained a submitted manuscript database. As an administrative assistant at Drexel University College of Medicine, Department of Psychiatry ( ) and Allegheny University Hospitals, Department of Anesthesiology ( ), Ms. Healy was responsible for preparing patient charts, collecting copays and referrals, scheduling appointments, and front-end billing in addition to maintaining academic and clinical files for committees, lectures, conferences, correspondence, and patient charts. She was heavily involved in communication with patients with a variety of conditions. Between 1988 and 1995, Ms. Healy was office manager of the Department of Biochemistry at Hahnemann University, where she also served as business manager and executive secretary to the chair simultaneously. In this role, she supervised daily responsibilities of support staff, assisted in the recruitment of work-study students, maintained time cards, and processed paperwork related to faculty recruitment. Ms. Healy has obtained continuing education from Philadelphia Community College, Hahnemann University, and, most recently, Rowan University, in areas such as English composition, medical terminology, psychology, anatomy, physiology, algebra and trigonometry, and project management. 25

28 2009 AAPM Awards Presidential Commendations Bifa Fan, MD Currently chief physician in the Department of Pain Management and professor of national pain management and research at Sino-Japan Friendship Hospital in Beijing, China, Dr. Fan has contributed to the establishment of a significant crosscultural connection between the Chinese Association for the Study of Pain (CASP), where he is president-elect, and the AAPM. In addition, Dr. Fan is the deputy editorin-chief of the Chinese Pain Medicine Journal, visiting professor at the State University of New York, and deputy director of the National Pain Management and Research Center. C. Roger Goucke, MB ChB DTM&H FANZCA FFPMANCZA FAChPM Dr. Goucke, clinical associate professor at the University of Western Australia and head of the Department of Pain Management at Sir Charles Gairdner Hospital, is recognized for his leadership in establishing the important cross-cultural connection between the Australian and New Zealand College of Anaesthetists (ANZCA) and the AAPM. Trained initially in anesthesia, Dr. Goucke has been practicing Pain Medicine for the last 10 years. He is past president of the Australian Pain Society and has served on the board of the Faculty of Pain Medicine of the Australian and New Zealand College of Anaesthetists since its foundation in Dr. Goucke is a reviewer for several peer-reviewed journals, including Pain Medicine and the Medical Journal of Australia in addition to reviewing regularly for grant authorities. Jisheng Han, MD A graduate of Shanghai Medical College and Dalian Medical College, Dr. Han is currently director of the Neuroscience Research Institute at Peking University and was previously professor and head of the Department of Physiology at Beijing Medical University. Dr. Han is recognized for his work in establishing a cross-cultural connection between the Chinese Association for the Study of Pain (CASP), where he is the founding president, and the AAPM and for his leadership in establishing Pain Medicine in China. He has mentored more than 80 research and postdoctoral fellows since 1973 and more than 60 PhDs since In total, Dr. Han has been invited to lecture on more than 200 occasions in 27 countries since He is an elected member of the Chinese Academy of Sciences and founding vice president of the Chinese Society for Neuroscience. Dr. Han served as editor-in-chief of Progress in Physiological Sciences and continues in this capacity for the Chinese Journal of Pain Medicine. He also was editor-in-chief of seven books. Internationally, Dr. Han acted as scientific advisor for the World Health Organization (WHO) and participated in the National Institutes of Health (NIH) and the Alcohol, Drug Abuse, and Mental Health Administration Re-Organization Act (ADAMHA) Scientific Review Committee and the executive committee of the International Narcotic Research Conference. 26

29 2009 AAPM Awards Presidential Commendations Daniel Kahikina Akaka Senator Akaka of Hawaii is the first U.S. senator of native Hawaiian ancestry and the only Chinese-American member of the Senate. One of Senator Akaka s most notable achievements affecting the field of Pain Medicine was introducing the Veterans Mental Health and Other Care Improvements Act of 2008, which makes various improvements to veterans mental health and other forms of care. Upon graduating high school, Senator Akaka served as a civilian worker before enrolling in active duty in the U.S. Army Corps of Engineers during World War II. Following the war, he returned to school at the University of Hawaii. After a career in education as a teacher and principal in the State of Hawaii Department of Education, Senator Akaka was elected to the House of Representatives in Since being appointed to the Senate, Senator Akaka has served on the Veterans Affairs Committee (chairman), the Armed Services Subcommittee on Readiness and Management, the Energy and Natural Resources Subcommittee on National Parks Historic Preservation and Recreation, and the Homeland Security and Governmental Affairs Subcommittee on Federal Government Management, the Federal Workforce, and the District of Columbia. He also serves on the Indian Affairs and Banking Committees and chairs the Congressional Task Force on Native Hawaiian Issues. Ben Shwachman, MD JD BS RPH Dr. Shwachman is recognized for his tireless service in Pain Medicine and the AAPM, in particular. Dr. Shwachman earned his law degree from Loyola University School of Law, his medical degree from the University of Illinois College of Medicine, and his pharmacy degree from the University of Illinois College of Pharmacy. He currently holds licensure for pharmacy in Illinois, for law in California, and for medicine in both California and Illinois, and he is certified by the American Board of Anesthesiology and the American Board of Pain Medicine. Dr. Shwachman is a member of the board of directors of the California Medical Association, past president of the California Society of Anesthesiologists, past president and current member of the board of directors of the Los Angeles County Medical Association, a past member of the board of directors of the AAPM and the California Academy of Pain Medicine, and serves as an AAPM representative to the Carrier Advisory Committee for Medicare. You Wan, MD PhD Dr. Wan is a professor in the Department of Neurobiology and the Neuroscience Institute at Peking University in Beijing, China, is recognized also for his work in fostering a partnership between the Chinese Association for the Study of Pain (CASP) and the AAPM. Dr. Wan is also director of the Key Laboratory for Neuroscience, Ministry of Education of China; vice dean of the School of Basic Medical Sciences at Peking University; executive director of the Department of Neurobiology in the School of Basic Medical Sciences at Peking University; and executive director of the Neuroscience Research Institute at Peking University. Dr. Wan serves on the editorial board or as a reviewer for numerous Chinese and international journals, including the Chinese Journal of Pain Medicine, Progress in Biochemistry and Biophysics, Chinese Journal of Biochemistry and Molecular Biology, European Journal of Neuroscience, and the British Journal of Anaesthesia, among others. Having authored or coauthored more than 70 articles in Chinese and international publications and as the recipient of various awards, including the 2008 IASP Award for Excellence in Pain Research and Management and the State Council Special Contribution Award of China, Dr. Wan s work is well recognized and respected. De Ren Zhang, MD Dr. Zhang is currently director of the Shenzhen NanShan Hospital in China and has also played a vital role in enabling a connection between the Chinese Association for the Study of Pain (CASP) and the AAPM. Dr. Zhang is an attending member and vice secretary general of CASP, vice president of the Guangdong Association for the Study of Pain (GASP), and president of the Shenzhen Association for the Study of Pain (SASP). He is professor at Huazhong Technology Universtiy Tongji Medical College and Guangdong Medical College in addition to serving as chief editor for Chinese Pain Medicine. 27

30 Past Award Recipients Philipp M. Lippe, MD Award 1995 Philipp M. Lippe, MD 1996 Joel Saper, MD 1997 Richard Stieg, MD 1998 Sridhar Vasudevan, MD 1999 Hubert Rosomoff, MD 2000 J. David Haddox, DDS MD 2001 Kathleen M. Foley, MD 2002 Michael Ashburn, MD MPH 2003 Daniel B. Carr, MD 2004 Robert G. Addison, MD 2005 Kenneth A. Follett, MD PhD 2006 Samuel J. Hassenbusch, MD PhD 2007 Scott M. Fishman, MD 2008 Benjamin L. Crue, Jr., MD FACS Founders Award 1995 Benjamin Crue, MD 1996 Wilbert Fordyce, PhD 1997 Peter Wilson, MBBS PhD 1998 Tony Yaksh, PhD 1999 Steven Feinberg, MD 2000 Rollin M. Gallagher, MD MPH 2001 Gary J. Bennett, PhD 2002 Russell Portenoy, MD 2003 Donald D. Price, PhD 2004 James C. Eisenach, MD 2005 Edward C. Covington, MD 2006 Gerald F. Gebhart, PhD 2007 Richard B. North, MD 2008 Michael J. Cousins, MD DSc FANZCA FRCA FAChPM(RACP) FFPMANZCA Distinguished Service Award 1996 Patricia Owen 1997 Not Awarded 1998 Paul Gebhard, JD Kristie Haley 1999 Peter Wilson, MBBS, PhD Ruth Tiernan 2000 Not Awarded 2001 Joel R. Saper, MD FACP FAAN 2002 Elliot Krames, MD 2003 Samuel J. Hassenbusch, MD PhD Jeffrey W. Engle 2004 Albert L. Ray, MD 2005 Rollin M. Gallagher, MD MPH 2006 Edward C. Covington, MD 2007 Eduardo M. Fraifeld, MD 2008 David A. Fishbain, MD DFAPA Patient Advocacy Award 2001 Warner Wood, MD 2002 Robert Biscup, MS DO 2003 Not Awarded 2004 Kenneth Moritsugu, MD MPH 2005 John (Jack) C. Lewin, MD 2006 Not Awarded 2007 Louis W. Sullivan, MD 2008 Robert D. Kerns, PhD Networking Opportunities and NPF Awards Presentation Visit the exhibit hall for your chance to learn about new products/services see the latest product innovations and updates to existing products and equipment speak with qualified vendors about the products they offer meet with your existing suppliers/vendors network with colleagues. See Page 34 or 59 for the exhibit hall schedule. All Attendees are invited to attend the National Pain Foundation (NPF) Pain Ambassador of the Year Presentation. Saturday, January 31 1:45 2 pm Coral Lounge 28

31 Hilton Hawaiian Village 29

32 Hotel Floor Plan First Level Mid-Pacific Conference Center W M CORAL 1 CORAL 5 3 CORAL 3 CORAL 2 CORAL M W M CORAL LOUNGE 2. NAUTILUS I 3. NAUTILUS II 4. NAUTILUS LOUNGE Second Level Mid-Pacific Conference Center SOUTH PACIFIC BALLROOM SEA PEARL SUITE SOUTH PACIFIC BOARD ROOM

33 25th Annual Meeting Supporters Platinum Level Gold Level Silver Level Bronze Level 31

34 Schedule At a Glance 32

35 Schedule At a Glance Celebrating 25 Years as the Voice of Pain Medicine 33

36 Schedule at a Glance Registration/Cyber Central Monday pm Tuesday.... 6:30 am 6 pm Wednesday... 6:30 am 6 pm Thursday... 6:30 am 4 pm Friday...6:45 am 4:30 pm Saturday.... 7:45 am 3 pm Speaker Ready Room Monday pm Tuesday.... 6:30 am 6 pm Wednesday... 6:30 am 6 pm Thursday... 6:30 am 4 pm Friday...6:45 am 4:30 pm Saturday.... 7:45 am 3 pm Exhibits Wednesday, January 28 Opening Reception in Exhibit Hall :30 pm Thursday, January 29 Exhibits Open am, 1:30 2:30 pm Reception in Exhibit Hall... 3:30 5 pm Friday, January 30 Exhibits Open am Posters In an effort to be more ecologically friendly, the AAPM will not be listing the poster abstracts in the printed program book. Instead, abstracts are included on the flash drive that was packaged with this program book. Group 1 This presentation group includes posters categorized by the following clinical topics: interventional, psychosocial/rehabilitation, and translational. Posters Wednesday, January 28, 3:30 pm through Thursday, January 29, 10 am Author-attended sessions Wednesday :30 pm Thursday am Group 2 This presentation group includes posters categorized by the following clinical topics: pharmacological, epidemiology/health policy/education. Posters Thursday, January 29, 3:30 pm through Friday, January 30, 10 am Author-attended sessions Thursday... 3:30 5 pm Friday am 34

37 Preconference Sessions Essentials of Pain Medicine Program* The 2-day Essentials of Pain Medicine program is designed for physicians who are interested in obtaining an overview of the fundamentals of Pain Medicine in addition to practical approaches to the treatment of common pain disorders. This program offers clinically focused lectures and case presentations on the assessment, diagnosis, and treatment of patients with various acute and chronic pain syndromes. Educational Objectives After completing this program, participants will be better able to evaluate the patient in pain describe the neurophysiology of pain transmission describe pharmacological, interventional, and rehabilitation techniques for the treatment of chronic pain implement protocols for appropriate prescribing practices understand how to treat pain and suffering in the patient with terminal illness understand the legal and ethical issues surrounding pain management. Day 1 Tuesday, January 27 7:15 11:15 am, 1 5 pm Day 2 Wednesday, January 28 7:30 11:30 am, 1:15 5:15 pm *There is an additional fee to attend this program. Preregistration is required. Tuesday, January pm Ultrasound Guidance for the Pain Physician (001)* Responding to an accelerated interest in the use of ultrasound-guided blocks in the treatment of Pain Medicine, this preconference session will provide an overview of the advantages as well as the limitations of this imaging modality in the practice of Pain Medicine. Expert faculty will engage with ultrasound novices to practice real-time techniques for common ultrasound procedures including nerve, joint, and axial procedures. In addition to the hands-on learning applications, attendees will have the opportunity to review literature regarding feasibility, safety, and patient outcomes. Educational Objectives At the completion of this course, attendees will be able to apply the diagnostic and interventional techniques of ultrasound technology, perform diagnostic musculoskeletal ultrasound examinations, and apply real-time ultrasound visualization to guide the needle to the target joint safely and efficiently. Attendees will become proficient in adjusting machine settings to optimize images, demonstrate basic ultrasound exams, and visualize needles through the use of ultrasound technology. Due to the hands-on interactive format of this session, space will be limited to 50 registrants. Preregistration is required. Faculty Mark F. Hurdle, MD Steven J. Wisniewski, MD Adam K. Jacob, MD Matthew J. Pingree, MD Bryan C. Hoelzer, MD Thomas B. Clark, DC RVT Marko Bodor, MD James C. Watson, MD 1 1:05 pm Introduction Mark F. Hurdle, MD 1:05 1:25 pm Joint Injections Steven J. Wisniewski, MD 1:25 1:45 pm Ultrasound-Guided Nerve Blocks Adam K. Jacob, MD 1:45 2 pm Ultrasound-Guided Axial Procedures Mark F. Hurdle, MD 2 5 pm Hands-On Workshop Matthew J. Pingree, MD Bryan C. Hoelzer, MD Thomas B. Clark, DC RVT Adam K. Jacob, MD Steven J. Wisniewski, MD Marko Bodor, MD James C. Watson, MD This educational program is supported through inkind donations from Biosound Esaote, Phillips, GE Healthcare, Diagnostic Instruments, Inc., and unrestricted medical education grants from GE Healthcare and Phillips. *There is an additional fee to attend this program. 35

38 Preconference Sessions Wednesday, January 28 7:30 am 4:45 pm Opioid Therapy: Cutting-Edge Scientific Approaches and Practical Strategies (002)* Healthcare professionals across the healthcare continuum work closely with patients who are experiencing various types and intensities of pain. Emerging advancements in pain management have given chronic pain patients and their families different types of treatment options that allow a renewed dimension to their quality of life. It is imperative that Pain Medicine clinicians keep up-to-date on emerging Pain Medicine assessment strategies, treatment options, and pharmacologic and nonpharmacologic approaches to the treatment of chronic noncancer pain. Although advances in pharmacologic management of pain have led to improved clinical outcomes, heightened awareness of the misuse of prescription opioid medications is a critical clinical and public-health concern that has significant impact on the healthcare delivery system. This full-day preconference session will review the major public-health concerns and examine the evidence of current epidemiology studies while exploring the association between effective chronic noncancer pain treatment and opioid misuse. In addition to addressing the ongoing ethical, legal, and regulatory implications, renowned faculty will unveil alternative and long-term treatment strategies to meet the ongoing needs of patients with dependence and addiction disorders. Educational Objectives After completing this session, participants will be able to understand the science of prescription opioid misuse and addiction assess and manage risks related to potential opioid abuse, addiction, and diversion incorporate best practices to optimize opioid use for the treatment of chronic pain identify pharmacologic mechanisms of opioid misuse and addiction identify challenges faced by pain specialists in navigating clinical and regulatory issues, and implement processes to overcome these challenges in their day-to-day practices improve pain management by enhancing communication skills between clinicians and patients summarize the APS-AAPM Chronic Opioid Therapy Guidelines. 7:30 7:40 am Introduction Scott M. Fishman, MD Ajay D. Wasan, MD MSc 7:40 8:30 am Update on the Science of Prescription Opioid Misuse and Addiction Howard A. Heit, MD FACP FASAM 8:30 9:20 am Use of Abuse-Resistant Formulations and Buprenorphine in a Pain Practice Michael H. Moskowitz, MD MPH 9:20 10:10 am Unappreciated Risks of Opioids: Endocrine Effects, Sleep-Disordered Breathing, and Hyperalgesia Lynn R. Webster, MD FACPM 10:10 11 am Recent Legal Controversies Surrounding Opioids Edward Michna, MD 11 11:30 am Question and Answer 11:30 am 1:15 pm Lunch Break 1:15 2 pm How to Be a Helpful Consultant Without Having to Write for Opioids Indefinitely: The Trilateral Agreement Ajay D. Wasan, MD MSc 2 2:45 pm Update on Methadone: Pitfalls, Toxicities, Drug-Drug Interactions, and Use in a Patient-Controlled Analgesia Pump Scott M. Fishman, MD 2:45 3:30 pm How to Run a Nurse-Practitioner or Physician-Assistant Opioid Clinic Rollin M. Gallagher, MD MPH 3:30 4:15 pm APS-AAPM Chronic Opioid Therapy Guidelines Perry G. Fine, MD 4:15 4:45 pm Question and Answer/Concluding Remarks *There is an additional fee to attend this program. 36

39 Plenary Sessions Wednesday, January :15 am Intrathecal Therapies for Chronic Pain: Old Challenges and New Developments (112)* Intrathecal drug delivery (IDD) for the management of intractable cancer and noncancer pain has been available for nearly 30 years. Advantages of IDD include effective pain control, fewer side effects compared with systemic medications, and the ability to easily adjust dosages and reverse the therapy. This course will provide a comprehensive overview of intrathecal therapy including pharmacologic sites of action; emerging therapies, including the most current consensus-based treatment algorithm; advances in medication delivery (equipment and programming); and potential complications arising from IDD and strategies to minimize their occurrence. 6 6:05 am Moderator Leonardo Kapural, MD PhD 6:05 6:25 am Novel Algorithm for Intrathecal Therapy: Rationale for Algorithm Changes Timothy R. Deer, MD 6:25-6:45 am Current Dilemmas and Future Challenges in Intrathecal Therapies: Opioids Versus Nonopioids Leonardo Kapural, MD PhD 6:45 7:05 am Complications of Intrathecal Therapies Including IT Granulomas B. Todd Sitzman, MD MPH 7:05 7:15 am Question and Answer This program is supported by an unrestricted educational grant from Elan Pharmaceuticals, Inc. *There is NO additional fee to attend this program. Thursday, January am Neuroplasticity and Chronic Pain (101) Norman Doidge, MD PhD DSc The revolutionary discovery of neuroplasticity, the science of brain regeneration, is arguably the most important breakthrough in neuroscience since the revelation of the brain s basic anatomy. In his keynote address, Norman Doidge, MD PhD DSc, unveils the scientific and transformational principles of neuroplasticity. Laying the foundation of this brain-science revolution is the discovery that the human brain is a changeable organ that can alter its own structure and function. Dr. Doidge will discuss the research and personal testimony that this movement holds for patients suffering from chronic pain. Dr. Doidge is a psychiatrist, psychoanalyst, researcher, best-selling author, award-winning science writer, poet, and four-time recipient of Canada s National Magazine Gold Award. He has presented scientific research and highlights of the brilliant scientists who champion this movement, as well as the personal testimony of the lives it has transformed. His New York Times best-selling book, The Brain That Changes Itself: Stories of Personal Triumph from the Frontiers of Brain Science, provides a fascinating synopsis of this emerging revolution in neuroscience. It bridges the gap between the amazing accomplishments of neuroscientists involved in this mind-bending research and the ultimate effects this research holds not only for patients with chronic pain but for all human beings. 8 8:30 am Plenary Research Highlights (102) Moderator Ajay D. Wasan, MD MSc Investigator-initiated research is crucial to the growth and the scientific basis of Pain Medicine as a specialty. Pain Medicine providers will have a greater burden to justify the scientific basis for their treatments, as well as to document their outcomes, as a result of the Pay for Performance movement. The reputation of the AAPM as a premier professional-service and scientific organization has resulted in a significant increase in the quality of cutting-edge scientific-research abstracts. The 2009 Scientific Poster Review Committee has selected two of the highest-ranking North American submissions to be presented live in this plenary venue. Faculty Joel Saper, MD Marek Kurowski, MD 37

40 Plenary Sessions Thursday, January 29 (continued) Friday, January 30 8:30 9 am AAPM President s Welcome Address (103) Kenneth A. Follett, MD PhD Dr. Follett s Welcome Address will also include the presentation of the AAPM s awards and the Presidential Commendations :40 am American Medical Association Address: Quality Patient Care (104) J. James Rohack, MD J. James Rohack, MD, a board-certified senior cardiologist from Scott & White Hospital, Temple, TX, currently serves as president-elect of the American Medical Association (AMA). In his address, Dr. Rohack will highlight the AMA s role in supporting physicians in the delivery of quality patient care and will provide AAPM members with the opportunity to engage in a dialogue on issues of mutual concern. Before becoming president-elect of the AMA, he served on the AMA Board of Trustees (BOT) as both a member and chair from 2004 to During his board tenure, he also served on all AMA BOT intraboard committees, chairing both the AMA BOT Executive Committee and the Organization and Operations Committee. In addition to his involvement with the AMA, Dr. Rohack has served as treasurer of the board of commissioners of the Joint Commission, chair of the National Advisory Council to the Agency for Healthcare Research and Quality, and as one of the principals of the Hospital Quality Alliance. A champion of advancing standards for continuing medical education, Dr. Rohack serves as a member of the AMA Council on Medical Education and the Steering Committee of the Federation of State Medical Boards and as an AMA representative to the Liaison Committee on Medical Education, ACCME, and the Liaison Committee on Specialty Boards. Dr. Rohack received his medical degree with honors from the University of Texas Medical Branch at Galveston. 10:45 11 am AAPM Annual Business Meeting 7:15 8:15 am The Loneliness of Science in Interventional Pain Medicine (105) Nikolai Bogduk, MD PhD DSc Though only a minority of medical graduates might be attracted to research, other fields such as cardiology, oncology, and immunology are complemented by healthy corners of research. This asset does not apply to interventional Pain Medicine. The hallmark of interventional Pain Medicine is ideas. Someone gets an idea about how to treat pain with a needle or an electrode and promotes it as a revolutionary new treatment. The necessary science is not acquitted. That science falls in two domains: critical reasoning (testing if a treatment really works) and basic sciences (establishing the mechanism by which the treatment works). Interventional Pain Medicine is replete with examples of failures and travesties in both domains. Assertion and clinical experience is maintained as superior to correct testing of outcomes. Basic sciences are often imaginary, invented, or misinformed. Examples include the presumption that injections of steroids should be effective without ever having detected inflammation, the placement of electrodes in locations where no nerve lies, and the expectation that a 2-mm heat lesion can cure a 2-cm fissure in an intervertebral disc. More pervasive is the assumption that placebo responses do not occur in clinical practice, either in the conduct of diagnostic blocks or in response to treatment. When scientists engage in this field, tragically it is too often to remove the dirt and noise, the residue, of adopting ideas without doing the necessary work. In psychosocial terms, interventional Pain Medicine has not evolved out of a guild status. The guilds resent the intrusion of science, and scientists are vilified because they offend the precepts of the guild and threaten what the guilds are designed to protect. Nikolai Bogduk, MD PhD DSc, a graduate in science and medicine from the University of Sydney with a PhD in neurology from the University of New South Wales, began his academic career in anatomy as professor of anatomy at the University of Newcastle. Committed to clinical research, Dr. Bogduk served as conjoint professor of Pain Medicine at the University of Newcastle and director of Newcastle Bone and Joint Institution. His research work has covered innervation of the spine, structure of the spinal muscles, biomechanics of the lumbar and cervical spine, validation of diagnostic blocks, discography for spinal pain and headache, and the evaluation of denervation procedures for the treatment of spinal pain. An international expert in Interventional Pain Medicine, Dr. Bogduk has earned multiple research awards, published nearly 200 referred papers, had 6 books translated into four languages, and wrote 124 chapters for books on the mechanisms, diagnosis, and treatment of pain. 38

41 Plenary Sessions 8:15 9 am Plenary Research Highlights (106) Moderator Jeffrey M. Tiede, MD The 2009 Scientific Poster Review Committee has selected two of the highestranking Asian, Australian, and New Zealand submissions to be presented live in this plenary venue. Faculty Colin S. Goodchild, MD PhD Tae Kyun Kim, MD PhD am Acupuncture: Historical Perspectives and Emerging Advances in the Treatment of Pain and Addiction (107) Jisheng Han, MD Widely practiced in China and other Asian countries for the treatment of chronic pain and addiction, acupuncture (the ancient Oriental art of healing) is clearly making its way into the western medical system. New research and ongoing studies from the National Institutes of Health provide firm ground for its principles, mechanisms, and efficacy in the treatment of chronic pain and addiction. Jisheng Han, MD, a professor of physiology and director of the Neuroscience Research Institute PUHSC, in Beijing, China, shares his findings on the effectiveness of acupuncture through brain imaging and molecular techniques; frequency versus site; dependency of electro-acupuncture effects; and opioid, nonopioid, and antiopioid mechanisms, as well as the critical role strengthening of homeostasis plays in the overall effectiveness of acupuncture therapy. A world-renowned physician, Dr. Han is a former member of the executive committee of the International Narcotic Research Conference (INRC) and the founder of the Chinese Association for the Study of Pain (CASP). In addition to receiving numerous honors, including the opportunity to deliver the Founders Lecture at the International Narcotics Research Conference (INRC) in Kyoto, Japan, Dr. Han has presented more than 200 invited lectures in 27 countries and published numerous articles on the analgesic effects of acupuncture. 3:15 4:15 pm Recent Advances in Complex Regional Pain Syndrome (113) Objective correlates of CRPS provide utility for diagnostic criteria. An understanding of the small-fiber changes that occur changes the way we evaluate the syndrome and raises questions about whether there is a difference between CRPS I and CRPS II. Rat models are permitting cellular and molecular investigation. Functional magnetic resonance imaging (fmri) of the brain of CRPS patients provides insight into the central nature of the syndrome. Ketamine and local anesthetic infusions are being studied on both an inpatient and outpatient basis and results will be presented. In recent years, the efficacy of spinal-cord stimulation for CRPS has been questioned. Relevant literature will be critically reviewed, with the goal of linking some of the pathophysiologic concepts with modern treatment. Moderator Joshua P. Prager, MD MS Objective Correlates in the Diagnosis of CRPS: Small-Fiber Changes Anne Louise Oaklander, MD PhD Functional Imaging in CRPS Sean Mackey, MD PhD CRPS and SCS: Evaluating the Evidence Joshua P. Prager, MD MS CRPS and Ketamine: A Look at Recent Protocols Joshua P. Prager, MD MS This educational program is supported through unrestricted medical education grants from Medtronic, Boston Scientific, and Advanced Neuromodulation Systems, Inc. 4:15 5:15 pm The Art of Pain Medicine: When Needles and Drugs Don t Work (108) Moderator Perry G. Fine, MD Panelists Norman Doidge, MD PhD DSc Kenneth A. Follett, MD PhD Leonardo Kapural, MD PhD Michael H. Moskowitz, MD MPH The mainstays of chronic Pain Medicine treatment after thorough assessment and diagnosis are disease-modifying interventions and mechanism-specific therapies, where applicable. When pain control cannot be attained rapidly by these means, interventional treatments or pharmacotherapy are often necessary in combination with functional restoration and behavioral and psychological management approaches. But what do we do when interventional and pharmacological therapies do not yield hoped-for therapeutic outcomes, or when we reach the limits of our understanding of pain mechanisms and available clinical science to manage pain effectively? When do psychosocial issues predominate? From the perspectives of several leaders in the field, this session will explore these questions and our ability to provide meaningful relief from pain and associated suffering to all pain patients. 39

42 Plenary Sessions Saturday, January :30 am Plenary Research Highlights (109) Moderator Leonardo Kapural, MD PhD The 2009 Scientific Poster Review Committee has selected two of the highestranking submissions to be presented live in this plenary venue. Faculty Rosemary C. Polomano, PhD RN Robert Edwards, PhD 8:30 9:30 am Pain Medicine in Older Adults: Preparing for a Paradigm Shift (110) Debra K. Weiner, MD Today, chronic pain in the elderly population is considered normal. It is often communicated to patients that pain is a normal part of aging, and frequently pain is not treated at all. Healthcare professionals who do try to treat pain are often unsuccessful because they do not have the right tools. Although there is an abundance of studies related to pain, only 1% address pain and aging. Given that the population of those age 65 years and older will increase by 75% between 2010 and 2030 while the number of people younger than 65 years will increase by only 6.5%, the time has come to change the way we treat pain in our elders. In this plenary address, Debra Weiner, MD, explores new models of care for treating chronic pain that are effective, efficient, and improve the quality of life of older adults. Dr. Weiner has presented lectures and published numerous articles on chronic pain in the elderly population and is the sole author of a chapter on pain for an American Geriatrics Society publication, Elder Care at Home; an editor of the American Geriatrics Society Public Education Forum Series; and a section editor for Pain and Aging in the journal Pain Medicine. Dr. Weiner received her medical degree from the University of Missouri in Columbia, MO am WAR and PAIN : From Battlefield to Back Home (111) WAR and PAIN: Regional Techniques on the Battlefield Chester Trip Buckenmaier III, MD COL MC Long-Term Management of Combat- Related Neuropathic Pain R. Norman Harden, MD Regional anesthesia is a field that is extremely important to the future of battlefield medical care and beyond. Used during the Vietnam War, it is not a new field; advancements in regional anesthesia techniques in combat hospitals and in hospitals back home are safe, effective, and improve patient care. Chester Trip Buckenmaier III, MD COL MC, highlights the advancements of regional anesthesia techniques being practiced by clinicians, ultimately improving the quality of care of our soldiers and beyond. Recognizing the critical role of opioids in the battlefield, Dr. Buckenmaier integrates regional anesthesia as a viable alternative to opioids and highlights the ability of regional anesthesia to improve overall pain management by reducing recovery time and postoperative complications. As chief of the Army Regional Anesthesia and Pain Management Initiative and professor of anesthesiology at the Uniformed Services University of Health Sciences, he is credited with starting the Army s Regional Anesthesia and Pain Management Initiative at Walter Reed Army Medical Center, which remains one of the few major medical institutions in the nation to routinely integrate advanced regional-anesthesia techniques into patient care. Connecting the battlefield triage and management strategies to postacute pain management and rehabilitation, R. Norman Harden, MD, will facilitate the voice of Pain Medicine on behalf of our veterans back home. 40

43 Concurrent Scientific Sessions Interventional Track Thursday, January 29 12:45 1:45 pm Electrical Neuromodulation: Justifying the Cost of Spinal-Cord Stimulation (201) This session discusses the impact of study, design, and execution of cost-effective interventional pain-therapy studies. Review of the cost-effectiveness of spinal-cord stimulation (SCS) reveals evidence questioning the ability of peerreviewed publications to ensure quality. Ways to improve cost-effectiveness, the cost impact of the position of SCS on the treatment continuum, and the cost impact of the routine SCS screening trial will be discussed. Providing a comprehensive framework for SCS efficacy uncovers ways to improve patient outcomes by utilizing consistent methodologies that include models, measures, and data-collection tools. 12:45 12:50 pm Moderator Richard B. North, MD 12:50 1:15 pm Review of the Evidence on the Cost-Effectiveness of SCS: What Types of Evidence Are Credible and Do Peer- Reviewed Publications Ensure Quality? Jane B. Shipley, BA NF 1:15 1:40 pm Development of a Model Framework for SCS Efficacy and Cost-Efficacy Studies: Improving Patient Outcomes by Agreeing on Study Methodology Richard B. North, MD 1:40 1:45 pm Question and Answer 2:30 3:30 pm Treatment Approaches to Discogenic Low-Back Pain: Surgical Versus Percutaneous (203) Intervertebral discogenic pain is a major source of lower back pain. Surgical treatment, such as fusion, is an area of controversy for which many have called for surgical restraint. Percutaneous treatment efficacy has also been called into question. This session presents the case study of a young person with discogram-positive, persistent, debilitating back pain despite conservative treatment. The following will be highlighted in this session: basic prevalence, pathophysiologic data, percutaneous treatments including biacuplasty, and the summation of advanced surgical treatments such as extreme lateral interbody fusion (XLIF). 2:30 2:35 pm Moderator Jeffrey M. Tiede, MD 2:35 2:50 pm Discogenic Low-Back Pain: Case Report and Summary of Prevalence and Pathophysiology Jeffrey M. Tiede, MD 2:50 3:05 pm Percutaneous Treatment of Discogenic Low-Back Pain Leonardo Kapural, MD PhD 3:05 3:20 pm Surgical Treatment of Discogenic Low-Back Pain Craig Meyer, MD 3:20 3:30 pm Question and Answer Friday, January 30 12:45 1:45 pm Cervical Spinal Injections: Significant Complications and Recommendations to Improve Safety (301) Cervical spinal injections have been associated with devastating complications that include hematoma, abscess, nerve and spinal-cord trauma, stroke, and death. Effective mechanisms for these problems, recommended management decisions, and effective strategies on how best to keep these complications out of your practice will be discussed. 12:45 12:50 pm Moderator Anthony H. Guarino, MD 12:50 1:05 pm Cervical Spinal Injections: Improving Outcomes and Safety Anthony H. Guarino, MD 1:05 1:20 pm Vascular Issues to Consider When Performing Spinal injections Marc Huntoon, MD 1:20 1:35 pm Spinal Injections: Complications and Recommendations for Safety Anthony H. Guarino, MD 1:35 1:45 pm Question and Answer 41

44 Concurrent Scientific Sessions Interventional Track friday, January 30 (continued) 2 3 pm Sacroiliitis: Contemporary Approaches for the Treatment of the Chronic Pain in the Butt (303) Multiple reviews indicate that 70% 80% of the current population will experience lower-back pain (LBP) at least once during their lifetime. LBP of sacroiliac joint (SIJ) origin is a difficult clinical diagnosis and often one of exclusion (Robert et al., 2000). SIJ has unique anatomical and physiological characteristics. Sacroiliac pain can be of intraarticular (e.g., arthritis, infection) or extraarticular origin (Cohen, 2005). Drawing on its unique anatomical and physiological characteristics, faculty contribute valuable observations regarding joint complex innervation, dermatomal pain referral, irritation of adjacent structures, and varying locations of injury with the SIJ (Ward et al., 2002). Perceived accessibility and low incidence of morbidity make therapeutic and diagnostic SIJ injection a common procedure that can bring long-standing pain relief in the office-based setting. 2 2:05 pm Moderator Leonardo Kapural, MD PhD 2:05 2:20 pm Sacroiliac Joint Injection: Today s Place in Therapy of Painful Sacroiliitis Leonardo Kapural, MD PhD 2:20 2:35 pm Anatomical Basis of Chronic Pain from Sacroiliitis Paul Dreyfuss, MD 2:35 2:50 pm Novel Radiofrequency Denervation Procedures for the Treatment of Painful Sacroiliitis Steven Cohen, MD 2:50 3 pm Question and Answer Saturday, January 31 12:45 3 pm Comprehensive Headache Symposium: International Perspectives on the Management of Headache Disorders (401) Cervicogenic (CV) headache is one of the most challenging areas for headache and Pain Medicine. Understanding the pathophysiology of CV headaches is critical to the application of appropriate diagnostic and therapeutic modalities. This interactive panel discussion will embrace the importance of a multidisciplinary management approach to the treatment of CV headaches by addressing comorbid diseases, pathophysiology, and sources of interventional advancements. In addition to CV headaches, this session will incorporate emerging advances in the diagnostic and therapeutic modalities of intractable and migraine headaches, as well as the emerging role neuromodulation plays in the overall treatment of headaches. 12:45 12:55 pm Moderator Zahid H. Bajwa, MD 12:55 1:15 pm Headache Disorders: Emerging Perspectives and Comprehensive Management Zahid H. Bajwa, MD 1:15 1:35 pm Interventional Management of Cervicogenic Headache Samer Narouze, MD MSc 1:35 2 pm Inpatient Management of Intractable Headache Joel Saper, MD 2 2:20 pm International Perspectives on the Management of Headache Disorders Zahid H. Bajwa, MD 2:20 2:40 pm The Role of Neuromodulation in Headache Therapy: Cranial and Occipital Nerve Stimulation for Migraine Headache Robert M. Levy, MD PhD 2:40 3 pm Question and Answer 42

45 Concurrent Scientific Sessions Integrative Track Thursday, January 29 12:45 1:45 pm Management of Chronic Pain Populations: Community, V.A., Managed Care, and Rural Approaches (202) The public health crisis of undertreated chronic pain in this country cannot be solved by the relatively few Pain Medicine specialists. The specialty of Pain Medicine must collaborate with primary care to address the needs of the community. This session discusses several working examples of how comprehensive Pain Medicine therapies are organized in the following three unique patient-care settings: a Pain Medicine center in a small southern rural city a regional network of pain-management centers based in the Midwest a pain program within a managed-care organization. Effective strategies for the best way to integrate treatment components into a community s healthcare system and practice barriers and advancements to overcome these barriers will be discussed. 12:45 12:50 pm Moderator Rollin M. Gallagher, MD MPH 12:50 1:05 pm Pain Care in the V.A. Setting Rollin M. Gallagher, MD MPH 1:05 1:15 pm Developing a Regional Pain-Management Network Fred N. Davis, MD 2:30 3:30 pm Pain Medicine Malpractice: Areas of Inquiry and Legal Updates (204) By exploring scientific literature in relation to medical malpractice litigation, this session will unveil the impact of the injury s attributes on the generation of the malpractice suit; the patient-physician relationship before, during, and after the injury; the impact of the patient s attributes on the generation of the malpractice suit; and the legal analysis of Pain Medicine malpractice case reports. 2:30 2:35 pm Moderator Rollin M. Gallagher, MD MPH 2:35 3 pm The Medical Malpractice Literature as it Relates to the Attribute of the Injury, Attributes of Involved Physicians, Attributes of the Patient-Physician Relationship, and Attributes of the Patient and Pain Medicine Recent Findings Rollin M. Gallagher, MD MPH 3 3:25 pm Legal Commentary and Discussion of Legal Issues Raised in Pain Medicine Malpractice Case Reports Ben Rich, PhD JD 3:25 3:30 pm Question and Answer 1:15 1:25 pm Primary Care and Managed Care Bill H. McCarberg, MD 1:25 1:35 pm Pain Care in a Small-Town Setting: Lessons Learned B. Todd Sitzman, MD MPH 1:35 1:45 pm Question and Answer 43

46 Concurrent Scientific Sessions Integrative Track Friday, January 30 12:45 1:45 pm Inheriting the Chronic Pain Patient: Breaking the Barriers and Regaining the Trust (302) The physically dependent, chronic pain patient without a regular prescriber poses a unique set of challenges that need to be carefully assessed and addressed. Addiction, physical dependence, tolerance, cross tolerance, and iatrogenic addiction are critical concepts that need to be examined to assist the prescriber in determining whether the patient is relief seeking rather than drug seeking. Interactive discussions regarding assessment strategies and management of the physically dependent pain patient will help the patient and prescriber to embark on a trial treatment plan before making a long-term therapeutic commitment. 12:45 12:50 pm Moderator Howard A. Heit, MD FACP FASAM 12:50 1:15 pm What the Healthcare Professional Should Know Before Treating the Inherited Patient Howard A. Heit, MD FACP FASAM 1:15 1:40 pm To Treat or Not to Treat? Issues to Consider Before Accepting an Established Chronic Pain Patient Into Your Practice Douglas Gourlay, MD FRCP 1:40 1:45 pm Question and Answer 2 3 pm Neuropathic Pain: Clinical Evaluation and Examination Pearls for the Practicing Pain Clinician (304) The majority of conditions treated by Pain Medicine providers have a neuropathic component, either as a mixed neuropathic condition or a pure neuropathic condition, such as diabetic peripheral neuropathy. Until now, no scientifically valid evaluation procedure has been available to the clinician. The Neuropathic Pain Research Consortium, a multiinstitution group of academic investigators, has developed a standardized, validated, and rapid bedside evaluation and exam for diagnosing and characterizing neuropathic pain. This session will effectively demonstrate through evaluation and exam how these techniques are a core skill set for Pain Medicine practitioners. 2 2:05 pm Moderator Ajay D. Wasan, MD MSc 2:05 2:20 pm Neuropathic Pain for the Practicing Pain Clinician Ajay D. Wasan, MD MSc 2:20 2:35 pm Review of the Validation Studies of the Protocol Miroslav Backonja, MD 2:35 2:50 pm How to Perform the History Portion of the Evaluation Mark S. Wallace, MD 2:50 3 pm Question and Answer 44

47 Concurrent Scientific Sessions Integrative Track Saturday, January 31 12:45 1:45 pm East Versus West International Perspectives on the Management of Cancer Pain (402) In our multicultural society, integrative patient care plays a prominent role in treating a wide variety of patients. This session presents an overview of interdisciplinary approaches to managing pain in cancer patients throughout the cancer experience. Most cancer patients face a combination of pain issues, including suffering from pain caused by a tumor, side effects or late effects of treatment, and pain unrelated to the disease itself. Pain-management strategies that work during active cancer treatment may not be as effective in the cancer survivor, and approaches may dramatically change in patients who have advanced diseases and are nearing the end of their lives. In pursuing best outcomes, unrelated noncancer pain will be addressed, in addition to providing psychological strategies aimed at mitigating suffering and as an overview of cancer pain management. 12:45 12:50 pm Moderator Larry C. Driver, MD 12:50 1:05 pm Broad-Spectrum Opioid and Adjuvant Cancer Analgesics Larry C. Driver, MD 1:05 1:20 pm Onco-Psychology : The Psychological Response to Cancer Pain and the Pain Response to Supportive Psychology Steven D. Passik, PhD 1:20 1:35 pm Eastern Perspectives on the Management of Cancer Pain C. Roger Goucke, MB ChB DTM&H FANZCA FFPMANCZA FAChPM 1:35 1:45 pm Question and Answer 2 3 pm Integrative Pain Care: Effective Management Through Multidisciplinary Collaboration (403) It takes a village to care for a child and a community of competent, dedicated professionals to care for patients with persistent and cancer-related pain disorders. The AAPM began accepting nonphysicians for membership in 2007, providing the impetus for this important session on interdisciplinary care that will provide innovative thoughts on treating patients with cancer and noncancer pain. Applying concepts developed in the chronic disease model can improve the quality of care offered to patients with pain, provider satisfaction in treating patients with pain, and utilization of limited healthcare resources. This interactive session will explore alternative strategies for relieving suffering associated with cancer, including the use of humor as a healing modality, and will address the importance of incorporating cultural competency in providing end-of-life care to Asians and Pacific Islanders. 2 2:05 pm Moderator Diane M. Keaney, MSN RN CNS 2:05 2:20 pm Successfully Treating Chronic Illness: The Need for an Interdisciplinary Approach Diane M. Keaney, MSN RN CNS 2:20 2:35 pm What s So Funny? Exploring the Clinical Impact of Humor Hob Osterlund, APRN CNS PCC 2:35 2:50 pm Cultural Differences at the End of Life: Asians and Pacific Islanders Patricia W. Nishimoto, DNSc MPH RN ONS 2:50 3 pm Question and Answer 45

48 Concurrent Scientific Sessions Integrative Track Saturday, January 31 (continued) 2 3 pm Mindfulness and Chronic Pain: A Practical Approach (404) Science encompasses the art of describing events with numbers and words and then applying those descriptions to the understanding of measurable phenomena. Understanding abstract, nonconceptual, intangible experiences such as mind states, moods, emotions, hopes, and fears has been challenging to physicians, particularly those in the field of Pain Medicine. Nowhere is this more deeply experienced with a constant drain on our inner and outer resources than in the field of chronic pain management. Mindfulness-based stress reduction (MBSR) is an invaluable tool that renews possibilities for living a healthy, fulfilling, meaningful life. The National Institutes of Health has invested millions of dollars into mindfulness-oriented research, and this session will offer mindfulness-based approaches from all 50 states. Ever since the introduction of mindfulness meditation and MBSR, there has been an accumulating body of research and clinical evidence underscoring the efficacy of this and other mindfulness-based approaches. In the last 5 years, this slowgrowing body of evidence has been generating an increasing amount of attention and interest that has resulted in a virtual explosion of new research and translational treatment approaches. This session will highlight mindfulness-oriented researchers and clinicians worldwide who are collaborating for the most robust science and the best practices and clinical approaches on mindfulness meditation. The chronic pain-management physician who understands MBSR can offer a comprehensive biopsychosocial treatment plan to his or her patients. 2 2:05 pm Moderator Michael H. Moskowitz, MD MPH 2:05 2:20 pm Best Practices: Identifying Clinical Approaches to MBSR Marcia Howton, MD 2:20 2:35 pm The Quintessence of the Biopsychosocial Approach to Chronic Pain Management Michael H. Moskowitz, MD MPH 2:35 2:50 pm Cognitive-Behavioral Approach to Pain Management Using a Biopsychosocial Perspective Michael J. Lewandowski, PhD 2:50 3 pm Question and Answer 46

49 Concurrent Scientific Sessions International Track Friday, January 30 12:45 1:45 pm Advances in Interventional Pain Management (305) China has evolved very quickly in the last few years from traditional medicine to a more western type of practice. This session will highlight the latest clinical experience of physicians practicing interventional pain procedures in both the United States and China, and will provide the audience the opportunity to assess different experiences on the newest techniques. Moderator Jisheng Han, MD Minimally Invasive Lumbar Fusion Lizu Xiao, MD Radiofrequency Heat Lesion of the Posterior Rami of Spinal Nerve for the Treatment of Low-Back Pain Bifa Fan, MD Latest Evidence for Best Treatment of Lumbar Herniated Disc Mark S. Wallace, MD 2 3 pm Training of Future Pain Medicine Physicians: International Perspectives (306) Pain Medicine was acknowledged as a new separate medical specialty in China by both medical and governmental authorities last year. A new challenge now exists: the training of Pain Medicine physicians to fulfill a growing demand from the Chinese healthcare system. This experience will be shared with U.S. pain physicians who are still trying to establish Pain Medicine as a specialty in this country. Moderator Michel Y. Dubois, MD The Chinese Experience as a New Medical Specialty: Its Impact on Training Pain Physicians You Wan, MD PhD Pain Medicine in the United States: How We Got There Rollin M. Gallagher, MD MPH Future of Pain Medicine Training in the United States: A Recipe for Success Michel Y. Dubois, MD 47

50 AAPM Faculty List and Disclosures Charles E. Argoff, MD Director Neurologic Rehabilitation North Shore University Hospital Northport, NY Eli Lilly and Company (advisory committee, consultant, speaker), Pfizer Inc. (consultant, speaker), King Pharmaceuticals (consultant, speaker), Vertex Pharmaceuticals (consultant), PriCara (consultant), Endo Pharmaceuticals (consultant, speaker) Miroslav Backonja, MD Director Education and Research Pain Treatment and Research Center Associate Professor Neurology and Anesthesiology University of Wisconsin Medical School Madison, WI Johnson & Johnson (consultant, researcher), Eli Lilly and Company (consultant, researcher), Merck & Co., Inc. (consultant, researcher), Pfizer Inc. (consultant, researcher), Neurogesx (consultant, researcher) Zahid H. Bajwa, MD Assistant Professor Anesthesia and Neurology Harvard Medical School Director Education and Clinical Pain Research Beth Israel Deaconess Medical Center Boston, MA Allergan, Inc. (speaker, research grant), Merck & Co., Inc. (speaker), Pfizer Inc. (speaker, research grants), Javelin (research grant), Johnson & Johnson (speaker), Eli Lilly and Company (speaker), Alpharma Pharmaceuticals (speaker, consultant) Nikolai Bogduk, MD PhD DSc Department of Clinical Research Newcastle Bone and Joint Institution Royal Newcastle Hospital Newcastle, New South Wales, Australia Nothing to disclose Marko Bodor, MD Queen of the Valley Medical Center Napa, CA Nothing to disclose Chester Trip Buckenmaier III, MD COL MC Chief Regional Anesthesia Chief Army Regional Anesthesia and Pain Management Initiative President Tri-Service Military Advanced Regional Anesthesia and Analgesia Initiative Uniformed Services University of Health Sciences Walter Reed Army Medical Center Bethesda, MD Nothing to disclose Thomas B. Clark, DC RVT MSKUS Diagnostics Vista, CA Nothing to disclose Steven Cohen, MD Anesthesiology, Pain Management Center Johns Hopkins University Baltimore, MD Baylis Medical Company (speaker, trial support) Fred N. Davis, MD Michigan Pain Consultants Grand Rapids, MI Nothing to disclose Timothy R. Deer, MD President and CEO Center for Pain Relief Charleston, WV St. Jude Medical (consultant), Bioness (researcher), Codman (consultant) Norman Doidge, MD PhD DSc Research Faculty Center for Psychoanalytic Training and Research Columbia University New York, NY Department of Psychiatry University of Toronto Toronto, ON, Canada Nothing to disclose Paul Dreyfuss, MD Clinical Professor Physical Medicine and Rehabilitation University of Washington Seattle, WA Baylis Medical Company (consultant), Smith & Nephew (consultant) Larry C. Driver, MD Adjunct Ethicist Clinical Ethics, Anesthesiology, and Pain Medicine M. D. Anderson Cancer Center Consultant University of Texas Houston, TX Nothing to disclose Michel Y. Dubois, MD President American Board of Pain Medicine Director Research and Education Professor Anesthesiology New York University School of Medicine New York, NY Nothing to disclose Robert Edwards, PhD Anesthesiology Brigham & Women s Hospital Chestnut Hill, MA Nothing to disclose Bifa Fan, MD President Chinese Association for the Study of Pain Professor Department of Medicine China-Japan Friendship Hospital Beijing, China Not available at time of publication Perry G. Fine, MD Professor Anesthesiology Pain Research Center University of Utah School of Medicine Salt Lake City, UT Alpharma Pharmaceuticals (advisory board), Cephalon, Inc. (advisory board consultant), Endo Pharmaceuticals (advisory board), Eli Lilly and Company (advisory board), Ortho-McNeil-Janssen Pharmaceuticals, Inc. (advisory board), Wyeth Pharmaceuticals (advisory board), GlaxoSmithKline (advisory board) Scott M. Fishman, MD Chief Division of Pain Medicine Department of Anesthesiology and Pain Medicine University of California Davis School of Medicine Lawrence J. Ellison Ambulatory Care Center Sacramento, CA Pfizer Inc. (consultant, researcher, advisory board), Purdue Pharma L.P. (consultant, researcher, advisory board), Alpharma Pharmaceuticals (consultant, researcher, advisory board, speaker) 48

51 AAPM Faculty List and Disclosures Kenneth A. Follett, MD PhD President American Academy of Pain Medicine Professor and Chief of Neurosurgery University of Nebraska Medical Center Omaha, NE Nothing to disclose Rollin M. Gallagher, MD MPH Director Pain Medicine Service Philadelphia Veterans Affairs Medical Center Director Pain Policy Research and Primary Care Penn Pain Medicine Clinical Professor Psychiatry and Anesthesiology University of Pennsylvania School of Medicine Philadelphia, PA Nothing to disclose Colin S. Goodchild, MD PhD Centre for Pain Medicine and Palliative Care Monash Institute of Medical Research Malvern, Victoria, Australia CNSBio (Chief Scientific Officer, researcher) C. Roger Goucke, MB ChB DTM&H FANZCA FFPMANCZA FAChPM Director Pain Management Department Sir Charles Gairdner Hospital Nedlands, Western Australia, Australia Nothing to disclose Douglas Gourlay, MD FRCP Wasser Pain Management Centre Mt. Sinai Hospital Waterdown, ON, Canada King Pharmaceuticals (consultant, speaker), Abbott Laboratoratories (consultant, speaker), Cephelon, Inc. (consultant, speaker), Purdue Canada (speaker), Schering Plough (speaker) Anthony H. Guarino, MD Director Pain Management Barnes Jewish West County Hospital Faculty Washington University St. Louis, MO Nothing to disclose Jisheng Han, MD Member Chinese Academy of Sciences Director Neuroscience Research Institute Professor Physiology Peking University Beijing, China Acupuncture Stimulator (consultant) R. Norman Harden, MD Associate Professor Physical Medicine and Rehabilitation Northwestern University Feinberg School of Medicine Director Center for Pain Studies Rehabilitation Institute of Chicago Chicago, IL Endo Pharmaceuticals (research), USB Corporation (research), GlaxoSmithKline (research), PriCara (advisory committee), Xenoport, Inc. (advisory committee) Howard A. Heit, MD FACP FASAM Assistant Clinical Professor Georgetown School of Medicine Georgetown University Fairfax, VA Purdue Pharma L.P. (speaker, consultant), Purdue Canada (speaker), Abbott Laboratoratories (speaker, consultant), Cephelon, Inc. (speaker, consultant), Endo Pharmaceuticals (consultant), Titan Pharmaceuticals (speaker, consultant), King Pharmaceuticals (speaker, consultant), Alpharma Pharmaceuticals (consultant), Heda Pharmaceuticals (consultant) Bryan C. Hoelzer, MD Department of Anesthesiology Mayo Clinic Rochester, MN Nothing to disclose Marcia Howton, MD Anesthesia Care Consultants Reno, NV Nothing to disclose Marc Huntoon, MD Anesthesiology/Pain Medicine Mayo Clinic Rochester, MN Medtronic (consultant) Mark F. Hurdle, MD Departments of Anesthesiology, Pain Medicine, and Physical Medicine and Rehabilitation Mayo Clinic Rochester, MN Nothing to disclose Adam K. Jacob, MD Mayo Clinic Rochester, MN Nothing to disclose 49 Leonardo Kapural, MD PhD Pain Management Department Cleveland Clinic Foundation Cleveland, OH Baylis Medical Company (speaker) Diane M. Keaney, MSN RN CNS Clinical Nurse Specialist Bay Area Pain Medical Associates Mill Valley, CA Nothing to disclose Tae Kyun Kim, MD PhD Anesthesiology and Pain Medicine Anesthesiology Pusan National University School of Medicine Busan, South Korea Nothing to disclose Paul Kreis, MD Professor Anesthesiology and Pain Medicine University of California Davis Sacramento, CA Pfizer Inc. (speaker), King Pharmaceuticals (speaker), Boston Scientific (consultant) Marek Kurowski, MD Physical Medicine and Rehabilitation Montefiore Medical Center Albert Einstein College of Medicine Bronx, NY Nothing to disclose Robert M. Levy, MD PhD Professor Neurological Surgery Associate Professor Physiology Northwestern University Feinberg School of Medicine Chicago, IL Advanced Neuromodulation Systems (consultant, researcher, speaker), Medtronic (consultant) Michael J. Lewandowski, PhD Clinical Associate Professor Department of Psychiatry and Behavioral Sciences University of Nevada School of Medicine Reno, NV Pain Assessment Resources (ownership interest), Chronic Pain Care Workbook (royalties) Sean Mackey, MD PhD Director Pain Management Division Stanford University School of Medicine Stanford, CA Not available at time of publication

52 AAPM Faculty List and Disclosures Gagan Mahajan, MD Associate Professor Anesthesiology and Pain Medicine University of California Davis School of Medicine Sacramento, CA Nothing to disclose Bill H. McCarberg, MD Chronic Pain Management Program Kaiser Permanente Escondido, CA Purdue Pharma L.P. ( speaker), Cephelon, Inc. (speaker), Alpharma Pharmaceuticals (speaker), Eli Lilly and Company (speaker), King Pharmaceuticals (speaker), Endo Pharmaceuticals (speaker), Merck & Co., Inc. (speaker), Pfizer Inc. (speaker), Pricara (speaker) Craig Meyer, MD Columbia Orthopaedic Group Columbia, MO NuVasive, Inc. (consultant, speaker), DePuy Spine, Inc. (consultant, researcher, teacher) Edward Michna, MD Department of Anesthesiology, Perioperative and Pain Medicine Pain Management Center Brigham and Women s Hospital Chestnut Hill, MA Alpharma Pharmaceuticals (speaker), King Pharmaceuticals (speaker), Johnson & Johnson (speaker), Pfizer Inc. (speaker), Cephalon, Inc. (speaker), UCB (consultant) Michael H. Moskowitz, MD MPH Adjunct Professor University of California Davis School of Medicine Bay Area Pain Medical Associates Mill Valley, CA Nothing to disclose Samer Narouze, MD MSc Department of Pain Management Cleveland Clinic Foundation Cleveland, OH Advanced Neuromodulation Systems (research) Patricia W. Nishimoto, RN MPH DNSc ONS Clinical Nurse Specialist Department of Hematology and Oncology Tripler Army Medical Center Honolulu, HI Nothing to disclose Richard B. North, MD Professor Neurosurgery LifeBridge Health Brain & Spine Institute Baltimore, MD Nothing to disclose Anne Louise Oaklander, MD PhD Associate Professor Neurology Harvard Medical School Neurology and Pathology Massachusetts General Hospital Boston, MA Nothing to disclose Hob Osterlund, APRN CNS PCC Pain Management Center The Queen s Medical Center Honolulu, HI Nothing to disclose Steven D. Passik, PhD Department of Psychiatry and Behavioral Sciences Memorial Sloan-Kettering Cancer Center New York, NY Cephalon, Inc. (consultant, speaker, research, grants), Ligand (consultant, speaker, research, grants), Eli Lilly and Company (consultant, speaker), Pricara (consultant, speaker), King Pharmaceuticals (consultant, speaker) Matthew J. Pingree, MD Departments of Anesthesiology, Neurology, and Physical Medicine and Rehabilitation Mayo Clinic Rochester, MN Nothing to disclose Rosemary C. Polomano, PhD RN Associate Professor Pain Practice University of Pennsylvania School of Nursing Philadelphia, PA Nothing to disclose Joshua P. Prager, MD MS Director Center for the Rehabilitation of Pain Syndromes University of California Los Angeles Los Angeles, CA Medtronic (speaker) Ben Rich, PhD JD Associate Professor Bioethics University of California Davis School of Medicine Sacramento, CA Nothing to disclose J. James Rohack, MD President-Elect American Medical Association Chicago, IL Nothing to disclose Joel Saper, MD Michigan Head Pain and Neurological Institute Ann Arbor, MI Merck & Co., Inc. (researcher, speaker), OMP (consultant, researcher, speaker), Purdue Pharma L.P. (speaker), Pfizer Inc. (consultant, researcher), Endo Pharmaceuticals (researcher), GlaxoSmithKline (researcher), Neuralieve (consultant, researcher), Pro Ethic Pharmaceuticals (researcher), Johnson & Johnson (researcher), Alexa (researcher), Allergan (consultant, researcher), Cypress Pharmaceutical, Inc. (researcher), Eli Lilly and Company (researcher), Advanced Neuromodulation Systems (consultant, researcher), MAP Pharmaceuticals, Inc. (researcher), Medtronic (consultant, researcher), TorreyPines Therapeutics (researcher), Schwartz Pharma (researcher) Jane B. Shipley, BA NF The Neuromodulation Foundation, Inc. Baltimore, MD Medtronic (consultant), Boston Scientific (consultant), Advanced Neuromodulation Systems, Inc. (consultant) B. Todd Sitzman, MD MPH Director Advanced Pain Therapy Forrest General Cancer Center Hattiesburg, MS Eli Lilly and Company (speaker), Cephalon (speaker), Codman (advisory board) Steven P. Stanos, DO Assistant Professor Department of Physical Medicine and Rehabilitation Northwestern University Feinberg School of Medicine Medical Director Center for Pain Management Rehabilitation Institute of Chicago Chicago, IL Abbott Laboratories (consultant,research, advisory), Endo Pharmaceuticals (consultant, speaker), Cephalon, Inc. (speaker), Eli Lilly and Company (speaker), Ortho- McNeill-Janssen Pharmaceuticals, Inc. (consultant, speaker) 50

53 AAPM Faculty List and Disclosures Jeffrey M. Tiede, MD Columbia Interventional Pain Center Columbia, MO Nevro Corporation (Consultant), Boston Scientific (speaker) Mark S. Wallace, MD Program Director Center for Pain Medicine University of California San Diego San Diego, CA Nothing to disclose You Wan, MD PhD Professor Neurobiology Neuroscience Research Institute Peking University Beijing, China Not available at time of publication Ajay D. Wasan, MD MSc Anesthesiology and Psychiatry Pain Management Center Harvard Medical School Brigham and Women s Hospital Chestnut Hill, MA Eli Lilly and Company (seaker, consultant), Medtronic (speaker, consultant) James C. Watson, MD Assistant Professor Neurology Consultant Departments of Neurology and Anesthesiology, Pain Medicine Mayo Clinic Rochester, MN Nothing to disclose Lynn R. Webster, MD FACPM Medical Director Lifetree Pain Clinic Salt Lake City, UT Abbott Laboratories (research), Advanced Bionics, LLC (research, consultant), Alpharma Pharmaceuticals (research, consultant), Ameritox (research), Array Pharma (research), AstraZeneca Pharmaceuticals (research), Boehringer Ingelheim (research), Cephalon, Inc. (consultant), CoMentis, Inc. (research), Durect Corporation (research), Elan Pharmaceuticals (consultant, research), Elite Pharmaceuticals, Inc. (research), Forest Pharmaceuticals, Inc. (research), GlaxoSmithKline (research), Jazz Pharmaceuticals, Inc. (research), King Pharmaceuticals (research, consultant), Medtronic (research, consultant), Merck & Co., Inc. (research), Nektar Therapeutics (consultant, research), Nervo Scope (consultant), NeurogesX (research), Orthocon (research), Predix Pharma (research), PTi international (research), Purdue Pharma L.P. (advisor, research), QRZ (research), Respironics (research), Takeda Pharmaceuticals (research), TorreyPines Therapeutics (research), Wyeth (research), Zars Pharma (research) Debra K. Weiner, MD Physician Institute on Aging Director Older Adult Pain Management Program Associate Professor Medicine, Psychiatry, and Anesthesiology University of Pittsburgh School of Medicine Pittsburgh, PA Nothing to disclose Steven J. Wisniewski, MD The Rehab Doctors Rapid City, SD Sonosite, Inc. (speaker) Lizu Xiao, MD Vice Director Pain Medicine Department Nanshan Hospital Nanshan, Shenzhen, China Not available at time of publication 51

54 Satellite Symposia Satellite symposia will be offered during breakfast, lunch, and dinner. These independently managed symposia are supported by the AAPM s Corporate Members. The symposia have been approved by the AAPM Program Committee for presentation as part of the AAPM Satellite Symposia program. These symposia are offered free of charge; however, preregistration is encouraged. Seating will be available on a first-come, firstserved basis. Registration and continuing medical education credit for these sessions are managed separately from the AAPM. Please contact the managing organizations directly with any questions. Tuesday, January 27, :30 am 12:45 pm Lunch Symposium 5:15 6:30 pm Dinner Symposium Practitioner s Edge SM Opioid Abuse, Misuse, and Diversion: Strategies for Prevention Opioids provide effective pain management for patients with acute and moderate to severe chronic pain who have not responded adequately to other pain management therapies. However, prescription opioid abuse has escalated along with increased legitimate use in pain management. Because of potential prescription abuse, patients and physicians may be reluctant to initiate opioid therapy for pain relief. Currently, there are several novel strategies to assist in prevention of opioid misuse, abuse, and diversion. This highly interactive Practitioner s Edge SM program will examine these novel clinical strategies in great detail. Practitioner s Edge SM is an innovative symposium format that provides attendees with cutting-edge medical education in a peer-to-peer discussion setting. The goal of the program is to provide practical tools and education that may be utilized immediately in daily practice. In this Practitioner s Edge SM program, a video vignette case study will be utilized to illustrate a clinically relevant example of opioid abuse. Faculty panel members will work with audience members to identify optimal treatment strategies while discussing the latest scientific information with regard to pain management. A multimedia presentation will be interspersed with audience response questions to further engage the audience and provide data for rigorous panel discussion. Learning Objectives Following this activity, participants will be able to: explain the scope of the problem of opioid misuse, abuse, and diversion review strategies for prevention of opioid misuse, abuse, and diversion describe novel formulations aimed at decreasing risks for opioid misuse, abuse, and diversion. Chairperson Scott M. Fishman, MD Faculty Richard C. Dart, MD PhD Nathaniel Katz, MD MS This independent commercially supported symposium is jointly sponsored by Integrity Continuing Education and Postgraduate Institute for Medicine and is supported by an educational grant from King Pharmaceuticals. 52 War on Pain: Beating the Chronic Pain Cycle on the Battlefield and Beyond Central to the innovations in pain assessment and management that have developed from the unprecedented suffering of war and battle is the concept that pain is a disease process, not simply a nociceptive response to injury. Instead, the working premise that chronic pain evolves from structural changes in central and peripheral neurons induced by inflammatory nociceptive response to acute pain was the basis for changes in care on the battlefield, during transport, and during rehabilitation. The following program and learning objectives have been targeted toward continuing education for clinicians who treat patients with pain and will guide the educational activity in demonstrating how to translate the innovations that arose during the care of combat casualties into improvements in universal pain assessment and treatment. In addition they will educate practitioners who are likely to see veterans from the GWOT in their practices about the unique complications that these men and women may face. Learning Objectives At the end of the program the participants will be able to define pain as a progressive disease process, not simply a response to injury demonstrate a patient-centered approach that will allow pain care practitioners to relate case examples by comparing and drawing parallels between the soldier or veteran patient and typical patients managed by Pain Medicine specialists interpret the latest evidence in neuroscience and epidemiology that projects understanding of the basis for and impact of innovative treatment of pain in the battlefield, post traumatic care setting, and longitudinal care as injured soldiers return to their communities in VA and non-va clinical settings consider the future state of patients with acute and chronic pain and outline the balance of risk and benefit in planning stratified multimodal treatment in the this pain population define consequences of unrelieved pain and summarize the importance of identifying and treating associated comorbidities in chronic pain and special populations.

55 Satellite Symposia Faculty Rollin M. Gallagher, MD MPH The Real Faces of Pain: A United Voice of Hope Micke Brown, BSN RN Derek McGinnis From the Battlefield to the Homefront Rollin M. Gallagher, MD MPH Where Do We Go From Here: 2009 and Beyond Scott M. Fishman, MD Moderated Panel Exchange (15 minutes) This independent commercially supported symposium is sponsored by MediCom Worldwide, Inc through an educational grant from Forest Laboratories, Inc. MediCom Worldwide, Inc is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Wednesday, January 28 11:45 am 1 pm Lunch Symposium Combining Pharmacologic and Nonpharmacologic Strategies: Optimizing Safe and Effective Opioid Therapy in Patients with Chronic Pain This symposium will examine the undertreatment of chronic pain and consider barriers to effective pain management. Through the interactive presentation of practical clinical cases, the expert faculty panel will translate the latest knowledge about behavioral, community, and pharmacologic interventions into outlines for integrated management strategies. The symposium will embrace advances in multidisciplinary pain management using an evidence-based approach. Learning Objectives Following completion, participants will be able to compare the efficacy of opioid analgesics and alternative therapies for the treatment of both malignant and noncancer pain implement strategies aimed at overcoming barriers to effective treatment for chronic pain describe emerging opioid formulations and combinations with the potential to decrease the risks for diversion and abuse identify best approaches to integrating nonpharmacologic and pharmacologic interventions to optimize outcomes for patients with chronic pain. Chairperson Charles Argoff, MD Faculty Scott M. Fishman, MD Bruce Nicholson, MD This independent commercially supported symposium is sponsored by Discovery Institute of Medical Education (DIME; org) through an educational grant from King Pharmaceuticals, Inc. DIME is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education (CME) for physicians. 6:30 7:45 pm Dinner Symposium Current Treatment Landscape and Emerging Management Options in Breakthrough Pain Breakthrough pain (BTP) is very common in cancer patients and has also been described in patients with chronic noncancer pain. BTP has a profound negative impact on quality of life and is associated with significant economic costs. Unfortunately, BTP is underrecognized and undertreated, leading to unnecessary patient suffering. A variety of barriers related to healthcare professionals, patients, and the healthcare system have been attributed to the lack of diagnosis and treatment. As a result, education on BTP and its treatment is essential. In this program, the pathophysiology and characteristics of BTP, its prevalence, and the negative impact on patients will be reviewed. The importance of treating BTP as a separate entity from baseline pain and treatment goals will be discussed. Current treatments will be explored, as well as new therapeutic options that may have faster onset of activity, greater flexibility in terms of dosing, and fewer side effects. Main areas of focus will be the need to assess each patient s BTP individually and tailor treatment to the patient, to evaluate the benefits and risks of treatment, and to identify those patients for whom the benefits of treatment outweigh the risks. Faculty Bill H. McCarberg, MD Bruce Nicholson, MD Lynn R. Webster, MD FACPM This independent commercially supported symposium is sponsored by MedXcel through an educational grant from MEDA Pharmaceuticals. CME credits will be awarded by Educational Review Systems (ERS). ERS is accredited by the ACCME to provide CME for physicians. 53

56 Satellite Symposia Thursday, January 29 5:30 6:45 am Breakfast Symposium Tackling the Pain Continuum: New Strategies to Break the Cycle of Acute and Chronic Pain More than 43 million surgical procedures are performed annually. Following surgery, a patient has a 50% 80% chance of experiencing unrelieved, acute postoperative pain. Efficient management of postoperative pain has been demonstrated to improve clinical outcome, and effective postoperative analgesia is part of a major initiative for U.S. hospitals. The undertreatment of pain has broad clinical implications and has been correlated with poor surgical outcomes such as delayed return to respiratory, bowel, and gastric function after surgery; immune suppression; and the development of chronic pain. The prevalence of persistent (i.e., longer than 3 6 months) postoperative pain remains alarmingly high and has been reported after numerous operative procedures. Chronic pain may begin as acute pain, but it then continues beyond the normal timeframe that is expected for it to be resolved or persists or recurs for other reasons. As much as 10% 20% of the U.S. adult population suffers from chronic pain that is often inadequately treated and debilitating. In the past decade, there have been remarkable advances in the field of pain management, including a better understanding of the basic sciences and predictability of pain, state-of-the-art drug delivery systems and formulations, and, most recently, emerging research that suggests new advances with novel pharmacologic modalities. The pain clinician must consider multiple perspectives for the selection of the most appropriate treatment modality. It is imperative they have access to the latest research and emerging data to comprehensively evaluate analgesic therapies for pain management. A multidisciplinary expert panel including perspectives from anesthesiologists, surgeons, general pain practitioners, neurologists, rheumatologists, physiatrists, and rehabilitation-medicine specialists will provide didactic sessions followed by an interactive questionand-answer discussion with the faculty panel that is moderated by the program chair. An audience response system will be used to facilitate an interactive program environment. Faculty TBA This independent commercially supported symposium is sponsored by SynerMed Communications through an educational grant from PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. CME credits will be awarded by Penn State College of Medicine. Penn State College of Medicine is accredited by the ACCME to provide CME for physicians. 11:15 am 12:30 pm Lunch Symposium Pain Management in Older Adults: Clinical Approaches to a Complex Problem The burden of unrelieved pain disproportionately affects older adults because the prevalence of many conditions, such as osteoarthritis, chronic low-back pain, post-herpetic neuralgia, and other painful conditions, increases with age. It is estimated that 20% 50% of older adults living in the community suffer from pain and as many as 80% of older adults living in nursing homes suffer as well. Consequences of unrelieved pain affect older patients in significant ways by decreasing mobility, inhibiting respiration, and decreasing functional status. Physiologic changes of aging affect the pharmacodynamics and pharmacokinetics of many drugs, while the central nervous system in older adults becomes increasingly sensitive to agents that affect brain function. Furthermore, older patients are at an increased risk of developing toxicity from oral nonsteroidal antiinflammatory agents. A comprehensive approach to pain management in older adults needs to include an appropriate assessment, appropriate goal setting, rational polypharmacy, and methods to improve psychosocial functioning and minimize side effects. Strategies for the appropriate use of opioids in older patients will be discussed as will the latest evidence for the ever-growing number of topical agents. Faculty Bruce Nicholson, MD (Program Chair) Steven P. Stanos, DO Debra K. Weiner, MD This independent commercially supported symposium is jointly sponsored by Postgraduate Institute for Medicine and MK Medical Communications, LLC, through an educational grant from Endo Pharmaceuticals Inc. CME credits will be awarded by the Postgraduate Institute for Medicine. The Postgraduate Institute for Medicine is accredited by the ACCME to provide CME for physicians. Postgraduate Institute for Medicine is accredited by the ACCME to provide CME for physicians. 5 6:15 pm Dinner Symposium Optimizing the Management of Disease-Specific Causes of Peripheral Neuropathic Pain Diabetic neuropathy, post-herpetic neuralgia, and HIV neuropathy are among the most commonly occurring peripheral neuropathic pain conditions in the United States. Treatment of these conditions continues to be the subject of extensive clinical investigation. Recent literature suggests that there are differences in how these forms of peripheral neuropathic pain are managed. The most recent treatment guidelines indicate that not all peripheral neuropathic pain conditions 54

57 Satellite Symposia Friday, January 30 respond to the most widely used treatments. Furthermore, treatment difficulties arise from the variable presentations associated with these conditions and from reduced recognition of peripheral neuropathic pain related to HIV. Recent treatment guidelines do not specifically address any of these peripheral neuropathic-pain conditions, underscoring the importance of reviewing treatment-related issues and updating management-related strategies. Understanding the strategies for optimal management of these forms of peripheral neuropathic pain is all the more essential given their detrimental effect on a patient s quality of life and the inevitability that their prevalence will increase in the coming years. The goal of this program is to review and clarify the pathophysiology, presentation, and treatment options for diabetic neuropathy, post-herpetic neuralgia, and HIV neuropathy. A discussion of new treatments currently in clinical development and their role as potential therapies for specific peripheral neuropathic-pain entities will also be featured. 5 5:05 pm Welcome and Introduction Srinivasa Raja, MD (Program Chair) 5:05 5:20 pm Current Advances in the Pathophysiology and Diagnosis of Diabetic Peripheral Neuropathy Arthur Vinik, MD PhD 5:20 5:35 pm Current Advances in the Pathophysiology and Diagnosis of Post-Herpetic Neuralgia Brett R. Stacey, MD 5:35 5:50 pm Current Advances in the Pathophysiology and Diagnosis of HIV Neuropathy David M. Simpson, MD 5:50 6:05 pm The Use of Analgesic Therapies for the Treatment of Disease-Specific Causes of Neuropathic Pain Srinivasa Raja, MD 6:05 6:15 pm Question and Answer All Faculty This independent commercially supported symposium is sponsored by Curatio CME Institute through an educational grant from NeurogesX, Inc. Curatio CME Institute is accredited by the ACCME to provide CME for physicians. 5:45 7 am Breakfast Symposium Dialogue with the Experts: An Exchange of Ideas (Roundtable Session) Individual roundtable discussion groups offer an opportunity to discuss topics of interest in Pain Medicine with notable experts. Multiple simultaneous roundtable discussions will each have an assigned moderator and discussion topic. Each moderator will facilitate an open dialogue among the roundtable participants to encourage the sharing of ideas and opinions among practicing pain specialists. Registration for individual roundtables will be offered 30 minutes before the session begins. Current topics and faculty include the following: Acupuncture as a Treatment for Pain Larry C. Driver, MD Adverse Event Protocol: Risk Management for Your Office- Based Pain Practice B. Todd Sitzman, MD MPH A Patient-Centered Approach to Urine Drug Testing Douglas L. Gourlay, MD FRCP The Opioid Renewal Clinic: Management of Patients Referred for Aberrant Behavior Rollin M. Gallagher, MD MPH Clinical Utility of Abuse-Deterrent Technologies Steven D. Passik, PhD Complex Regional Pain Syndrome: What It Is and How to Treat It Paul J. Christo, MD Ethical Dilemmas in Pain Management Michel Y. Dubois, MD Controlled Substances and the Law Ben A. Rich, PhD JD Controversies Around Intrathecal Therapy Timothy R. Deer, MD Definition, Diagnosis, and Management Strategies for Neuropathic Pain Miroslav Backonja, MD Disability, Physical Rehabilitation, and Chronic Pain Martin Grabois, MD (Chairperson) Evidence-Informed Management of Chronic Low-Back Pain Jerome Schofferman, MD Opioid Treatment for Osteoarthritis: Who, Why, and How? Zahid H. Bajwa, MD Pain and Aging Perry G. Fine, MD Rational Use of Interventional Pain Treatments James P. Rathmell, MD 55

58 Satellite Symposia Risk Factors for Aberrant Drug-Related Behavior Among Patients with Chronic Pain Faculty TBA The Effects of Opioids on Cognition and Driving Ability in Patients with Chronic Pain Michael Byas-Smith, MD The Fibromyalgia Conundrum: Defining, Diagnosing, and Treating Bill H. McCarberg, MD The Neurobiologic and Pharmacologic Interface of Pain and Psychiatric Disorders Michael H. Moskowitz, MD MPH The Role of Urine and Alternative Biofluid Drug Testing in Patient Care Lynn R. Webster, MD FACPM Topical Agents for the Treatment of Pain Steven P. Stanos, DO Urine Drug Testing in Pain Medicine: Pearls and Pitfalls Howard A. Heit, MD FACP FASAM This independent commercially supported symposium is sponsored by PharmaCom Group through an educational grant from Alpharma Pharmaceuticals LLC. CME credits will be awarded by the Center for Continuing Education, which is accredited by the ACCME to provide CME for physicians. 11:15 am 12:30 pm Lunch Symposium From PCP to Pain Specialist: A Case-Based Approach to the Management of Patients With Moderate to Severe Chronic Pain This program is designed to equip physicians and other healthcare providers with the most up-to-date educational information regarding current treatment options for the management of chronic pain, and how to optimize positive outcomes through appropriate management of the patient from the primary care provider to the pain specialist. A comprehensive discussion of emerging technologies in pain management, including new advances in pharmacologic treatments will also be included. An embedded case study, including audience response questions, will help facilitate a thorough discussion of these topics. Upon completion of this activity, participants will discuss unmet needs in pain management and how to appropriately transition a patient from the primary care provider to the pain specialist examine the safety, efficacy, and tolerability of current and emerging treatment options, including immediate- and extended-release opioid analgesics, for the appropriate management of patients with chronic pain apply appropriate treatment approaches to optimize patient outcomes. Faculty Perry G. Fine, MD (Program Chair) Bill H. McCarberg, MD This independent commercially supported symposium is jointly sponsored by the University of Wisconsin School of Medicine and Public Health and The Academy for Continued Healthcare Learning through an educational grant from Abbott. 56

59 Satellite Symposia Saturday, January 31 6:30 7:45 am Breakfast Symposium Clinical Concepts in Pain and Aging Pain is the most common symptom mentioned by older adults who consult healthcare providers. Older adults are defined as individuals who are age 65 years or older, but their healthcare needs require further refinement into the middle old (65 74 years), the old old (75 85 years), and the oldest old (older than 85 years). Musculoskeletal pain, typically from osteoarthritis and other bone and joint disorders, is the most common cause of persistent pain in older adults. For too many older patients, old age and pain are synonymous. Older adults are set to overwhelm our healthcare system, as the first Baby Boomers will turn 65 in 2011 just 3 years from now. The prevalence of persistent pain ranges from 25% to 50% in older adults (Ferrell, 1995) and increases to 45% 80% in elderly nursing-home residents. For older adults with pain, the cost of healthcare increases 3 5 times. Practitioners need to understand the unique challenges in evaluating and treating pain in the aging and the appropriate clinical care that will drive improved patient outcomes. The format of this symposium will combine video case studies, audience interactivity, and faculty debate. Participants will review two case studies that will be presented by two course moderators who will then allow two other faculty members to present their perspectives, experiences, and opinions on the management of those case studies. Audience interactivity will be further enhanced by audience response systems. The instructional goal is to create a positive change in physician practice and impart critical insights into both patient and disease management. Moderator Paul Christo, MD Reference Ferrell, B. A. (1995). Annals of Internal Medicine, 123, This independent commercially supported symposium is sponsored by Gullapalli & Associates through an educational grant from Purdue Pharma L.P. CME credits will be awarded by Johns Hopkins School of Medicine. Johns Hopkins School of Medicine is accredited by the ACCME to provide CME for physicians. 11:15 am 12:30 pm Lunch Symposium Optimal Pain Management in Fibromyalgia Syndrome: Current and Emerging Therapeutic Options An Interactive CME Symposium with Patient Case Videos Using a unique, highly interactive, video patient-case teaching format, this symposium is intended to provide clinicians who treat fibromyalgia patients with new insights and strategies. Attendees will have multiple interactive opportunities to reinforce their own best practices or recognize potential gaps 57 in their clinical practice and receive information that will improve patient outcomes. By focusing on the most challenging aspects of fibromyalgia and its accompanying comorbidities, it is the aim of this program to provide information that will give physicians a better understanding of the mechanisms underlying the pain of fibromyalgia, knowledge about existing and emerging therapeutic options, and provide guidance on the differential diagnosis, comprehensive management, and education of their fibromyalgia patients. Learning Objectives Upon completion of this CME activity, participants will be better able to 1. understand the pathophysiology and pain mechanisms involved in fibromyalgia syndrome 2. differentiate fibromyalgia syndrome from other similar forms of chronic muscle or musculoskeletal pain 3. utilize current clinical data to understand the use of current and emerging pharmacologic treatments and determine the appropriate management strategy for optimal pain relief in a fibromyalgia patient 4. recognize the neurobiologic, physiologic, psychologic, and behavioral factors that can be present in a patient with fibromyalgia and how these might impact treatment 5. create and implement multimodal treatment strategies to decrease pain and improve function in fibromyalgia. Fibromyalgia Pain Mechanisms: Functional Neuroimaging and Other Factors David A. Williams, PhD Fibromyalgia: Mastering the Differential Diagnosis Bill H. McCarberg, MD Optimal Fibromyalgia Management: Assessing the Potential of Current and Emerging Therapies Steven P. Stanos, DO This symposium is supported by an educational grant from Eli Lilly and Company. This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of Purdue University School of Pharmacy and Health Education Alliance, Inc. Purdue University School of Pharmacy, an equal access/equal opportunity institution, is accredited by the ACCME to provide continuing medical education for physicians. Purdue University School of Pharmacy designates this educational activity for a maximum of 1.25 AMA PRA Category 1 Credits. Physicians should only claim credit commensurate with the extent of their participation in the activity.

60 Exhibit Hall Floor Plan Hilton Hawaiian Village Coral Ballroom Poster Session Schedule The six highest-ranking poster authors have been selected to present their posters during three plenary sessions. These sessions will be held as follows: Thursday, January 29, 8 8:30 am... 2 North American winners Friday, January 30, 8:15 9 am Pacific Rim winners Saturday, January 31, 8 8:30 am North American winners Scientific posters will be on display in the Coral Ballroom Foyer. There will be two presentation groups of posters this year. Presentation Group 1 The first presentation group includes posters categorized by clinical topic of interventional, psychosocial/ rehabilitation, or translational. This Scientific Poster Session begins on Wednesday, January 28 at 3:30 pm. Posters will remain on display through 10 am on Thursday, January 29. Poster Session and Opening Reception Wednesday, January 28, 5 6:30 pm Exhibit and Poster Break Thursday, January 29, 9 10 am Presentation Group 2 The second presentation group includes posters categorized by clinical topic of pharmacological or epidemiology/ health policy/education. This Scientific Poster Session begins on Thursday, January 29 at 3:30 pm. Posters will remain on display through 10 am on Friday, January 30. Reception with Posters and Exhibits Thursday, January 29, 3:30 5 pm Exhibit and Poster Break Friday, January 30, 9 10 am 58

61 List of Exhibitors The AAPM exhibit program will showcase products and services specifically designed for leaders in the study and treatment of pain. By visiting these vendors, you will learn more about advancements that can keep you and your organizations at the forefront of your field. AAPM exhibitors feature products and information in the following areas: pharmaceuticals, medical supplies and equipment, medical publications, alternate delivery systems, and more. As an accredited provider of Continuing Medical Education, the AAPM does not endorse any commercial products displayed in conjunction with the Annual Meeting. Company Booth Abbott Laboratories AIT Laboratories Alliance of State Pain Initiatives... F804 Alpharma Pharmaceuticals LLC American Academy of Pain Medicine.... By Registration American Chronic Pain Association... F803 Ameritox Aspen Medical Products Biosound Esaote Ultrasound Biowave Boston Scientific Calloway Labs Cephalon, Inc Clint Pharmaceuticals, Inc Cosman Medical, Inc Custom Compounding Centers Diagnostic Instruments, Inc Dominion Diagnostics Elan Pharmaceuticals, Inc Eli Lilly and Company Elsevier, Saunders, Mosby Emerging Solutions in Pain Endo Pharmaceuticals INC GE Healthcare Havel s Inc Hayden Medical, Inc Healthpac Computer Systems Horizon Medical World Intellisphere, LLC Kimberly-Clark King Pharmaceuticals , 619 Company Booth Meda Pharmaceuticals Medtox Laboratories Medtronic, Inc Millennium Laboratories National Pain Foundation... F801 NECC (New England Compounding Center) Nektar Therapeutics NeurogesX Neuromed NeuroTherm Inc PainDX, Inc Pearson Assessments Physician Partner Physicians Choice Services PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc Purdue Pharma L.P SonoSite, Inc SpineMED-CERT Health Sciences St. Jude Medical Victory Pharma Wiley-Blackwell Wyeth Pharmaceuticals Exhibit Schedule Wednesday, January 28 Opening Reception in Exhibit Hall :30 pm Thursday, January 29 Exhibits Open am, 1:30 2:30 pm Reception in Exhibit Hall... 3:30 5 pm Friday, January 30 Exhibits Open am 59

62 List of Exhibitors Exhibitors by Product Category Billing/EMR Healthpac Computer Systems, Inc. Education Alliance of State Pain Initiatives American Academy of Pain Medicine American Chronic Pain Association Elsevier, Saunders, Mosby Emerging Solutions in Pain National Pain Foundation Pearson Assessments Laboratory Testing AIT Laboratories Ameritox Calloway Labs Dominion Diagnostics Hayden Medical, Inc. MEDTOX Laboratories Millennium Laboratories Medical Books/Journal Wiley-Blackwell Medical Devices Aspen Medical Products Biosound Esaote Ultrasound Biowave Boston Scientific Cosman Medical, Inc. Diagnostic Instruments, Inc. GE Healthcare Havel s Inc. Kimberly-Clark Medtronic, Inc. PainDX, Inc. SonoSite, Inc. SpineMED-CERT Health Sciences St. Jude Medical Medical Publishing Intellisphere, LLC Medical Software Horizon Medical World Multiservice Provider Physicians Choice Services Pharmaceuticals Abbott Laboratories Alpharma Pharmaceuticals LLC Cephalon, Inc. Clint Pharmaceuticals, Inc. Custom Compounding Centers Elan Pharmaceuticals, Inc. Eli Lilly and Company Endo Pharmaceuticals Inc. King Pharmaceuticals Meda Pharmaceuticals Nektar Therapeutics NECC (New England Compounding Center) NeurogesX Neuromed Physician Partner PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Purdue Pharma L.P. Victory Pharma Wyeth Pharmaceuticals NeuroTherm Inc. 60

63 Exhibitors BOOTH 504 Corporate Abbott Member 200 Abbott Park Road Abbott Park, IL / fax 847/ Abbott is a global, broad-based healthcare company devoted to discovering new medicines, new technologies, and new ways to manage health. Our products span the continuum of care, from nutritional products to medical devices and pharmaceutical therapies. Our comprehensive product line encircles life itself, addressing important health needs for all ages. BOOTH 706 AIT Laboratories 2265 Executive Drive Indianapolis, IN / fax 317/ AIT Laboratories offers state-of-the-art analyses for pain management and clinical clients nationwide. Based in Indianapolis, AIT s services include access to board-certified toxicologists; onsite, instant-cup testing to identify drug misuse in new patients; a comprehensive urinalysis to monitor compliance; and immediate access to results via online reporting at BOOTH F804 Alliance of State Pain Initiatives 1300 University Avenue, Room 4720 Madison, WI / fax 608/ The Alliance of State Pain Initiatives (ASPI) is a network of interdisciplinary, state-based organizations dedicated to improving the care of persons with pain. The National Office of the ASPI develops educational, advocacy, and institutional improvement programs and provides resources and guidance to the State Pain Initiatives. BOOTH 204 Corporate Alpharma Pharmaceuticals LLC Member 440 Route 22 East Bridgewater, NJ / fax 908/ Alpharma Inc. (NYSE: ALO) is a global specialty pharmaceutical company with leadership positions in products for humans and animals. Alpharma is presently active in more than 80 countries. Alpharma has a growing branded pharmaceutical franchise in the U.S. pain market with its KADIAN (morphine sulfate extended-release) Capsules and the FLECTOR Patch (diclofenac epolamine topical patch). Booth By Registration American Academy of Pain Medicine 4700 West Lake Avenue Glenview, IL / fax 877/ BOOTH F803 American Chronic Pain Association P.O. Box 850 Rocklin, CA / fax 916/ Since 1980, the ACPA has offered peer support and coping skills to help people with pain begin their journey from patient to person. The ACPA continues to offer programs and services designed to provide support, encouragement, information, and coping skills that help a person with pain regain control of their life. Our philosophy has always been to help a person with pain improve quality of life and increase functioning while reducing their sense of suffering. 800/ or BOOTH 518 Corporate Ameritox Member 3501 North A Street, Building B, Suite 200 Midland, TX / fax 432/ Ameritox is the nation s leader in pain prescription monitoring. Only Ameritox offers RxGuardian, the most thorough and personalized lab report available. RxGuardian determines compliance based on prescription regimens. Peace of mind is provided to physicians by providing data to help ensure that patients are taking pain medications as prescribed. BOOTH 617 Aspen Medical Products 6481 Oak Canyon Irvine, CA / fax 949/

64 Exhibitors BOOTH 119 Biosound Esaote Ultrasound 8000 Castleway Drive m Bronze Level Supporter Indianapolis, IN / fax 317/ Biosound Esaote is a market leader in musculoskeletal portable and console-based diagnostic ultrasound systems. Offering unique MSK features that provide comprehensive diagnoses and high-level functionality and excellent value, Biosound Esaote s highly recognized Mylab series provides an easy transition to becoming a Diagnostic and Interventional MSK Specialist. BOOTH 115 Biowave 16 Knight Street Norwalk, CT / fax 801/ Biowave sells two neuromodulation pain therapy devices: Deepwave is an in-office, billable percutaneous 30-minute procedure that breaks the pain cycle over 4 6 treatments; Homewave is a follow-on noninvasive prescription system allowing the patient to maintain their comfort at home. Both systems treat chronic, acute, or post-operative musculoskeletal pain in the body. Treatments provide a 75% reduction in pain and a significant functional improvement that lasts for hours. BOOTH 212 Boston Scientific Rye Canyon Loop m Bronze Level Supporter Valencia, CA / fax 866/ Boston Scientific s Neuromodulation Division is a global leader in the development of implantable, high-technology neuromodulation devices that include the Precision Plus SCS system for chronic pain. The unique ability to precisely sculpt electric fields has resulted in unprecedented acceptance of this system. Boston Scientific is a worldwide developer, manufacturer, and marketer of medical devices whose products are used in a broad range of interventional medical specialties. BOOTH 501 Calloway Labs 34 Commerce Way Woburn, MA / fax 781/ BOOTH 312 Cephalon, Inc. 41 Moores Road Frazer, PA F Silver Level Supporter Corporate Member 610/ fax 610/ Cephalon s Pain Care Franchise includes therapies for breakthrough pain and muscle spasms. FENTORA (fentanyl buccal tablet) [C-II] is indicated for breakthrough pain in opioid-tolerant patients with cancer. AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Tablets), the only oncedaily skeletal muscle relaxant, is indicated for muscle spasm associated with acute, painful musculoskeletal conditions. BOOTH 523 Clint Pharmaceuticals, Inc. 629 Shute Lane Old Hickory, TN / fax 615/ BOOTH 519 Cosman Medical, Inc. 76 Cambridge Street Burlington, MA / fax 781/ BOOTH 608 Custom Compounding Centers 3525 Del Mar Heights Road, #31 San Diego, CA / fax 858/ BOOTH 707 Diagnostic Instruments, Inc. 211 Asquithview Lane Arnold, MD / fax 410/ BOOTH 417 Corporate Dominion Diagnostics Member 211 Circuit Drive North Kingstown, RI / fax 401/ Dominion Diagnostics is a fully certified national medical laboratory specializing in clinical quantitative urine drug testing, scientifically accurate medication monitoring, and fully integrated clinical support services. Dominion provides information regarding patient prescription adherence, illicit drug usage, addiction, and substance misuse for a diversity of medical specialties, including pain and addiction medicine. 62

65 Exhibitors BOOTH 101 Elan Pharmaceuticals, Inc. 800 Gateway Blvd. South San Francisco, CA m Bronze Level Supporter Corporate Member 650/ Elan Corporation, plc is a neuroscience-based biotechnology company that is focused on discovering, developing, manufacturing, and marketing advanced therapies in neurology, autoimmune diseases, and severe pain. BOOTH 616 Eli Lilly and Company Lilly Corporate Center Indianapolis, IN m Bronze Level Supporter Corporate Member 317/ Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, IN, Lilly provides answers through medicines and information for some of the world s most urgent medical needs. BOOTH 220 Elsevier, Saunders, Mosby 1600 JFK Blvd., Suite 1800 Philadelphia, PA / fax 215/ Elsevier is dedicated to being your integral partner in delivering exceptional health care. Trust Elsevier to offer superior resources that expand your knowledge, foster communication, build insights, and enable individual and collective advancement in the healthcare field. Elsevier proudly publishes Mosby, Saunders, Churchill Livingstone, Butterworth- Heinemann, and Hanley & Belfus titles. Elsevier. Building Insights. Breaking Boundaries. BOOTH 114 Emerging Solutions in Pain 101 Washington Street Morrisville, PA / fax 800/ Emerging Solutions in Pain is a nonbranded, disease awareness initiative focused on chronic pain management and the issues of abuse and misuse of and addiction to opioids. Our diverse array of resources were developed to assist clinicians in overcoming the challenges they face when treating patients with pain. Today s source for tomorrow s pain management! BOOTH 104 Corporate Endo Pharmaceuticals Member 100 Endo Blvd. Chadds Ford, PA / fax 610/ Endo Pharmaceuticals Inc. is a fully integrated specialty pharmaceutical company with market leadership in pain management. Endo researches, develops, produces, and markets a broad product offering of branded and generic pharmaceuticals, meeting the needs of healthcare professionals and consumers alike. Booth 610 GE Healthcare 9900 Innovation Drive Wauwatosa, WI / m Bronze Level Supporter BOOTH 319 Havel s Inc Lonsdale Street Cincinnati, OH / fax 513/ Havel s presents new echogenic needles for ultrasound-guided joint and tendon injections and peripheral nerve blocks. As the exclusive U.S. distributor for Hakko Medical in Japan, Havel s has been providing a variety of new, safer specialty needles since BOOTH 222 Hayden Medical, Inc B Soledad Canyon Road, #411 Santa Clarita, CA / fax 877/ BOOTH 703 Healthpac Computer Systems 1010 E. Victory Drive Savannah, GA / fax 912/ Healthpac Computer Systems, a 27-year-old national software development company with installations in 43 states, offers HIPAA-compliant medical billing and practice-management software along with a CCHIT-certified EMR. Our software has been specifically designed for anesthesia and pain management. See why we have the most comprehensive system on the market. 63

66 Exhibitors BOOTH 524 Horizon Medical World 7481 Warden Road Sherwood, AR / fax 866/ BOOTH 120 Intellisphere, LLC 666 Plainsboro Road, Suite 300 Plainsboro, NJ / fax 609/ Reaching more than 36,000 pain specialists across 11 specialties, MDNG: Pain Management Edition is the guide to the medical Internet for pain specialists. Our coverage enables busy practitioners to keep up-to-date with the rapidly evolving world of pain management and medical technology, remain aware of the most reliable online medical resources (including online CME and the latest clinical trial information), and gain insight into the most important issues that affect their specialties. BOOTH 601 Kimberly-Clark 1400 Holcomb Bridge Road Rosewell, GA / fax 920/ Booth 512, 619 King Pharmaceuticals, Inc. 400 Crossing Blvd. Bridgewater, NJ m Bronze Level Supporter Corporate Member 908/ fax 908/ King Pharmaceuticals, Inc. focuses on development, growth, and promotion of innovative and trusted medicines. Dedicated to improving and protecting quality of life for people around the world, King works diligently to successfully develop and deliver superior pharmaceutical products while operating in a socially responsible manner. BOOTH 418 Meda Pharmaceuticals 265 Davidson Avenue Somerset, NJ T Platinum Level Supporter Corporate Member 732/ medapharma.us Meda Pharmaceuticals is a global specialty pharmaceutical company that develops, markets, and promotes branded prescription products in the respiratory and pain therapeutic areas. BOOTH 218 Medtox Laboratories 432 West County Road D St. Paul, MN / fax 866/ MEDTOX is a national reference laboratory founded in 1984, offering the highest-quality testing with unparalleled service and industry-leading technology for effective pain management testing. The TOXASSURE program is designed as a comprehensive process to ensure your program is complete and effective in monitoring patient compliance through laboratory analysis. BOOTH 412 Medtronic, Inc Central Avenue NE Minneapolis, MN l Gold Level Supporter Corporate Member 763/ fax 763/ Medtronic is the global leader in medical technology alleviating pain, restoring health, and extending life for millions of people around the world. Medtronic pain therapies and spinal diagnostics businesses provide comprehensive solutions for diagnosing the source of back pain and managing chronic pain, bringing new hope to patients. BOOTH 712 Millenium Laboratories Via Tazon, Suite F San Diego, CA / fax 858/ Millenium Laboratories is revolutionizing therapeutic drug monitoring and urine drug testing. We offer physician practices the opportunity to perform and bill for point-of-care testing in their offices. Confirmations are performed with state-of-the-art LC/MS-MS analyzers. We offer the fastest turnaround for confirmations in the industry. BOOTH F801 National Pain Foundation 300 E. Hampden Avenue, Suite 100 Aurora, CO / fax 303/ NPAC (National Pain Awareness Campaign) is a joint program of the NPF and AAPM, designed to raise awareness of pain issues and help educate both nonpain healthcare providers and the public. Visit the NPF booth to learn more, and register to become a Pain Awareness Ambassador to help build awareness on pain issues in your community. 64

67 Exhibitors BOOTH 111 NECC (New England Compounding Center) 697 Waverly Street Framingham, MA / fax 888/ NECC is a compounding-only pharmacy dedicated to providing the highest-quality compounded medications and service to patients and prescribers. NECC is USP Chapter 797-compliant and formulates all medications with only the highest-grade chemicals in their state-of-the-art compounding facility. BOOTH 217 Nektar Therapeutics 201 Industrial Road San Carlos, CA / fax 650/ Nektar Therapeutics is a biopharmaceutical company developing a robust pipeline of high-value therapeutics to address unmet medical needs by leveraging its industry-leading PEGylation and pulmonary drug development platforms. In the area of pain, NKTR-118 (oral PEG-naloxol) is in Phase 2 clinical development to potentially treat patients suffering from opioid-bowel dysfunction (OBD), including opioidinduced constipation (OIC). BOOTH 317 Corporate NeurogesX Member 2215 Bridgepointe Parkway, Suite 200 San Mateo, CA / fax 650/ NeurogesX is a biopharmaceutical company based in the San Francisco Bay Area. Our focus is on the development of effective treatments that relieve chronic pain and improve quality of life. Our leading product candidate, NGX-4010, has the potential to revolutionize the treatment of neuropathic pain because a single application may potentially provide months of relief. BOOTH 709 Neuromed Six Tower Bridge, Suite Washington Street Conshohocken, PA Corporate Member BOOTH 710 NeuroTherm Inc. 2 Debush Avenue, Suite A-2 Middleton, MA / fax 978/ NeuroTherm is the world leader in radiofrequency for pain management. Our flagship RF generator, the NT1100, now offers new technology with Simplicity III and Diskit II, as well as patient data reports, multielectrode options, automatic lesioning, and Pulse Dose. With our wide offering of innovative RF products and remarkable level of service, physicians are able to perform procedures more safely, quickly, and effectively. BOOTH 517 PainDX 2514 Temple Hills Drive Laguna Beach, CA / fax 800/ AXON-II detects pain fiber pathology with sensitivity approaching 100% and is painless, fast, and can be performed by a nurse. It also conforms to AMA Code and is reimbursable by all types of insurance. PainDX, Inc. is the sole manufacturer and distributor of this product. Sales include certification fees through American Association of Sensory Medicine. BOOTH 113 Pearson Assessments 5601 Green Valley Drive Bloomington, MN / fax 952/ Pearson is the global leader in educational publishing, assessment, information, and services, helping people of all ages to learn at their own pace, in their own way. For students prek 12, Pearson provides effective and innovative curriculum products in all available media, educational assessment and measurement for students and teachers, student information systems, and teacher professional development and certification programs. 65

68 Exhibitors BOOTH 224 Physician Partner 3607 Old Conejo Road Thousand Oaks, CA / fax 800/ Physician Partner specializes in all areas of in-office dispensing. We provide prepackaged pharmaceuticals, DME, and injectables for your practice s needs. Our no-fee, Web-based dispensing system allows you to maximize profits and assure patient convenience and compliance. Our programs include guaranteed Workers Compensation claims processing, collections, and other billing-related services. BOOTH 201 Physicians Choice Services 766 Southeast 5th Avenue Del Ray Beach, FL / fax 561/ BOOTH 107 Corporate PriCara, Division of Ortho-McNeil- Member Janssen Pharmaceuticals, Inc Route 202 Raritan, NJ / fax 908/ PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. is dedicated to serving primary care physicians. We currently market products to treat pain, acid reflux disease, and infectious diseases. BOOTH 404 Purdue Pharma L.P. One Stamford Forum Stamford, CT / fax 203/ BOOTH 318 SonoSite th Drive SE Bothell, WA / fax 425/ BOOTH 117 SpineMED-CERT Health Sciences 7036 Golden Ring Road Baltimore, MD / fax 866/ F Silver Level Supporter Corporate Member Booth 604 St. Jude Medical 6901 Preston Road Plano, TX / fax 972/ m Bronze Level Supporter BOOTH 522 Victory Pharma 3700 Regency Parkway, Suite 130 Cary, NC / fax 919/ Victory Pharma is a specialty pharmaceutical company focused on pain management. Victory has a portfolio of products that we market to healthcare providers through our growing commercial organization. Victory was incorporated in 2003 and is headquartered in San Diego, CA, with a commercial office near Research Triangle Park, NC. BOOTH 702 Wiley-Blackwell 350 Main Street Malden, MA / fax 781/ wiley.com Congratulations to the American Academy of Pain Medicine on their 25th anniversary! As the society s partner, Wiley- Blackwell is privileged to publish Pain Medicine, the field s most respected clinical pain journal. Stop by Booth 702 to pick up free journal samples and find answers to your clinical questions in our wide assortment of books. Wiley-Blackwell is the scientific, technical, medical, and scholarly publishing business of John Wiley & Sons. Learn more at: com/wiley-blackwell. BOOTH 223 Corporate Wyeth Pharmaceuticals Member 500 Arcola Road Collegeville, PA / fax 484/ Wyeth is one of the world s largest research-driven pharmaceutical and healthcare products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products, and nonprescription medicines that improve the quality of life for people worldwide. 66

69 Thank You AAPM Gratefully Acknowledges Its Corporate Members Pharmaceuticals 67

70 Notes 68

71 Notes 69

72 Notes 70

73 Notes Activity Purpose The purpose of this activity is to examine the instrumental role of integrated pain management programs that include nonpharmacologic and pharmacologic interventions for achieving and maintaining adequate analgesia while minimizing the risk of opioid abuse and diversion in patients with chronic pain. Accreditation Statement DIME (Discovery Institute of Medical Education) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Designation Statement DIME designates this educational activity for a maximum of 1.25 AMA PRA Category 1 Credits. Physicians should only claim credit commensurate with the extent of their participation in the activity. Optimizing Safe and Effective Opioid Therapy in Patients With Chronic Pain Hilton Hawaiian Village Tapa Ballroom 3 (Located on the second floor of the Tapa Tower) Honolulu, Hawaii Registration There is no registration fee for this satellite symposium. Seating is limited and will be available on a first-come, first-served basis. Early arrival is recommended to guarantee seating. To preregister for this symposium, please visit or contact Cathy Rickert at Preregistration does not guarantee seating. Onsite registration will be held in the foyer of Tapa Ballroom 3 at the Hilton Hawaiian Village on Wednesday, January 28, 2009, beginning at 11:15 a m. Please call us at before your arrival if you have special needs or dietary limitations that we can address to make your participation more enjoyable. Wednesday January 28, :15 am 11:45 am Registration and Lunch 11:45 am 1:00 pm Symposium Sponsored by Chairperson* Charles E. Argoff, MD Faculty* Bruce D. Nicholson, MD Scott M. Fishman, MD Editor* Nancy Moran An official independent satellite symposium held in conjunction with the 25th Annual Meeting of the American Academy of Pain Medicine This activity is funded through an educational grant from *Current guidelines state that participants in CME/CE activities should be made aware of any affiliation or financial interest that may affect those involved with content development or presentation. Those involved have completed a Statement of Disclosure, and their names and disclosure information will appear in the activity materials. This information is used to: (1) determine whether a conflict exists, (2) resolve the conflict by initiating a content validation process, and (3) advise learners of this information. Information unavailable at the time of printing will be made available for review before the presentation / DIME 71

74 the AMERICAN ACADEMY of PAIN MEDICINE Plan now to attend the 26th Annual Meeting January 3 6, 2010 San Antonio, T X Look for the call for proposals online at 72

75 73

76 Emerging Solutions in Pain Guiding Pain Management Visit us at booth #114 at the AAPM 25th Annual Meeting in Honolulu, Hawaii January 28-31, 2009 Outcomes Today Emerging Solutions in Pain (ESP) is an ongoing initiative that has been developed to address some of the most critical issues in pain management today. Enhance your learning through expanded multimedia features which include: Podcasting Video FAQs Accredited clinical case studies The foundation of the website is the ESP Tool Kit, a multimedia collection of educational resources focusing on patient assessment for the risk of misuse, abuse and addiction, patient monitoring throughout the treatment plan and best practices for clinicians to help optimize patient care. Try our newest features Ask the Experts Do you have challenging questions about pain management and addiction? State Your Case Submit your challenging case studies for review by ESP faculty. Journal Club A great way to increase your knowledge about timely peer-reviewed articles. Scholarship Program A wonderful opportunity for residents, fellows and registered nurses to attend a Leading Pain Management conference! Visit MLS Medical Learning Solutions 74 Supported by an independent educational grant from

77 FENTORA (fentanyl buccal tablet) CII BRIEF SUMMARY: Please see full prescribing information. PHYSICIANS AND OTHER HEALTHCARE PROVIDERS MUST BECOME FAMILIAR WITH THE IMPORTANT WARNINGS IN THIS LABEL. Reports of serious adverse events, including deaths in patients treated with FENTORA have been reported. Deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients) and/or improper dosing. The substitution of FENTORA for any other fentanyl product may result in fatal overdose. FENTORA is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-theclock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid daily for a week or longer. FENTORA is not indicated for use in opioid non-tolerant patients including those with only as needed (PRN) prior exposure. FENTORA is contraindicated in the management of acute or postoperative pain including headache/ migraine. Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients. When prescribing, do not convert patients on a mcg per mcg basis from Actiq to FENTORA. Carefully consult the Initial Dosing Recommendations table. (See DOSAGE AND ADMINISTRATION, Table 7.) When dispensing, do not substitute a FENTORA prescription for other fentanyl products. Substantial differences exist in the pharmacokinetic profile of FENTORA compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of FENTORA for any other fentanyl product may result in fatal overdose. Special care must be used when dosing FENTORA. If the breakthrough pain episode is not relieved after 30 minutes, patients may take ONLY one additional dose using the same strength and must wait at least 4 hours before taking another dose. (See DOSAGE AND ADMINISTRATION.) FENTORA contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. FENTORA can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing FENTORA in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Patients and their caregivers must be instructed that FENTORA contains a medicine in an amount which can be fatal to a child. Patients and their caregivers must be instructed to keep all tablets out of the reach of children. (See Information for Patients and Caregivers for disposal instructions.) FENTORA is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain. The concomitant use of FENTORA with strong and moderate cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression. INDICATIONS AND USAGE (See BOXED WARNING and CONTRAINDICATIONS) FENTORA is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer. This product must not be used in opioid non-tolerant patients because life-threatening hypoventilation and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, FENTORA is contraindicated in the management of acute or postoperative pain. FENTORA is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain. CONTRAINDICATIONS FENTORA is contraindicated in opioid non-tolerant patients. FENTORA is contraindicated in the management of acute or postoperative pain including headache/migraine. Life-threatening respiratory depression and death could occur at any dose in opioid non-tolerant patients. FENTORA is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl. WARNINGS (See BOXED WARNING) When prescribing, DO NOT convert a patient from Actiq to FENTORA, without following the instructions found in the prescribing information as Actiq and FENTORA are not equivalent on a microgram per microgram basis. FENTORA is NOT a generic version of Actiq. When dispensing, DO NOT substitute a FENTORA prescription for an Actiq prescription under any circumstances. FENTORA and Actiq are not equivalent. Substantial differences exist in the pharmacokinetic profile of FENTORA compared to other fentanyl products including Actiq that result in clinically important differences in the rate and extent of absorption of fentanyl. As a result of these differences, the substitution of the same dose of FENTORA for the same dose of Actiq or any other fentanyl product may result in a fatal overdose. There are no safe conversion directions available for patients on any other fentanyl products (Note: This includes oral, transdermal, or parenteral formulations of fentanyl.) Therefore, for opioid tolerant patients, the initial dose of FENTORA should be 100 mcg. Each patient should be individually titrated to provide adequate analgesia while minimizing side effects. (See DOSAGE AND ADMINISTRATION.) Use with CNS Depressants The concomitant use of other CNS depressants, including other opioids, sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines, potent inhibitors of cytochrome P450 3A4 isoform (e.g., erythromycin, ketoconazole, and certain protease inhibitors), and alcoholic beverages may produce increased depressant effects. Hypoventilation, hypotension, and profound sedation may occur. FENTORA is not recommended for use in patients who have received MAO inhibitors within 14 days, because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics. Pediatric Use: The safety and efficacy of FENTORA have not been established in pediatric patients below the age of 18 years. Patients and their caregivers must be instructed that FENTORA contains a medicine in an amount which can be fatal to a child. Patients and their caregivers must be instructed to keep tablets out of the reach of children. (See SAFETY AND HANDLING, PRECAUTIONS, and MEDICATION GUIDE for specific patient instructions.) Drug Abuse, Addiction and Diversion of Opioids: FENTORA contains fentanyl, a mu-opioid agonist and a Schedule II controlled substance with high potential for abuse similar to hydromorphone, methadone, morphine, oxycodone, and oxymorphone. Fentanyl can be abused and is subject to misuse, and criminal diversion. Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. However, all patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common. Drug-seeking behavior is very common in addicts and drug abusers. Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Since FENTORA tablets may be diverted for non-medical use, careful record keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised. Proper assessment of patients, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. FENTORA should be handled appropriately to minimize the risk of diversion, including restriction of access and accounting procedures as appropriate to the clinical setting and as required by law. Healthcare professionals should contact their State Professional Licensing Board, or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product. Physical Dependence and Withdrawal: The administration of FENTORA should be guided by the response of the patient. Physical dependence, per se, is not ordinarily a concern when one is treating a patient with cancer and chronic pain, and fear of tolerance and physical dependence should not deter using doses that adequately relieve the pain. Opioid analgesics may cause physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity, e.g., naloxone, nalmefene, or mixed agonist/antagonist analgesics (pentazocine, butorphanol, buprenorphine, nalbuphine). Physical dependence usually does not occur to a clinically significant degree until after several weeks of continued opioid usage. Tolerance, in which increasingly larger doses are required in order to produce the same degree of analgesia, is initially manifested by a shortened duration of analgesic effect, and subsequently, by decreases in the intensity of analgesia. Respiratory Depression: Respiratory depression is the chief hazard of opioid agonists, including fentanyl, the active ingredient in FENTORA. Respiratory depression is more likely to occur in patients with underlying respiratory disorders and elderly or debilitated patients, usually following large initial doses in opioid nontolerant patients, or when opioids are given in conjunction with other drugs that depress respiration. Respiratory depression from opioids is manifested by a reduced urge to breathe and a decreased rate of respiration, often associated with the sighing pattern of breathing (deep breaths separated by abnormally long pauses). Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. This makes overdoses involving drugs with sedative properties and opioids especially dangerous. PRECAUTIONS General: Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery). Patients taking FENTORA should be warned of these dangers and should be counseled accordingly. The use of concomitant CNS active drugs requires special patient care and observation (See WARNINGS). Chronic Pulmonary Disease: Because potent opioids can cause respiratory depression, FENTORA should be titrated with caution in patients with chronic obstructive pulmonary disease or pre-existing medical conditions predisposing them to respiratory depression. In such patients, even normal therapeutic doses of FENTORA may further decrease respiratory drive to the point of respiratory failure. Head Injuries and Increased Intracranial Pressure: FENTORA should only be administered with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO 2 retention such as those with evidence of increased intracranial pressure or impaired consciousness. Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted. Application Site Reactions: In clinical trials, 10% of all patients exposed to FENTORA reported application site reactions. These reactions ranged from paresthesia to ulceration and bleeding. Application site reactions occurring in 1% of patients were pain (4%), ulcer (3%), and irritation (3%). Application site reactions tended to occur early in treatment, were self-limited and only resulted in treatment discontinuation for 2% of patients. Cardiac Disease: Intravenous fentanyl may produce bradycardia. Therefore, FENTORA should be used with caution in patients with bradyarrhythmias. Hepatic or Renal Disease: Insufficient information exists to make recommendations regarding the use of FENTORA in patients with impaired renal or hepatic function. Fentanyl is metabolized primarily via human cytochrome P450 3A4 isoenzyme system and mostly eliminated in urine. If the drug is used in these patients, it should be used with caution because of the hepatic metabolism and renal excretion of fentanyl. Information for Patients and Caregivers 1. Patients and their caregivers must be instructed that children, especially small children, exposed to FENTORA are at high risk of FATAL RESPIRATORY DEPRESSION. Patients and their caregivers must be instructed to keep FENTORA tablets out of the reach of children. (See SAFETY AND HANDLING, WARNINGS, and MEDICATION GUIDE for specific patient instructions.) 2. Patients and their caregivers must be provided a Medication Guide each time FENTORA is dispensed because new information may be available. 3. Patients must be instructed not to take FENTORA for acute pain, postoperative pain, pain from injuries, headache, migraine or any other short term pain, even if they have taken other opioid analgesics for these conditions. 4. Patients must be instructed on the meaning of opioid tolerance and that FENTORA is only to be used as a supplemental pain medication for patients with pain requiring around-the-clock opioids, who have developed tolerance to the opioid medication, and who need additional opioid treatment of breakthrough pain episodes. 5. Patients must be instructed that, if they are not taking an opioid medication on a scheduled basis (around-the-clock), they should not take FENTORA. 6. Patients should be instructed that the titration phase is the only period in which they may take more than ONE tablet to achieve a desired dose (e.g., two 100 mcg tablets for a 200 mcg dose). 7. Patients must be instructed that, if the breakthrough pain episode is not relieved after 30 minutes, they may take ONLY ONE ADDITIONAL DOSE OF FENTORA USING THE SAME STRENGTH FOR THAT EPISODE. Thus, patients should take a maximum of two doses of FENTORA for any breakthrough pain episode. 8. Patients must be instructed that they MUST wait at least 4 hours before treating another episode of breakthrough pain with FENTORA. 9. Patients must be instructed NOT to share FENTORA and that sharing FENTORA with anyone else could result in the other individual s death due to overdose. 10. Patients must be aware that FENTORA contains fentanyl which is a strong pain medication similar to hydromorphone, methadone, morphine, oxycodone, and oxymorphone. 11. Patients must be instructed that the active ingredient in FENTORA, fentanyl, is a drug that some people abuse. FENTORA should be taken only by the patient it was prescribed for, and it should be protected from theft or misuse in the work or home environment. 12. Patients must be instructed that FENTORA tablets are not to be swallowed whole; this will reduce the effectiveness of the medication. Tablets are to be placed between the cheek and gum above a molar tooth and allowed to dissolve. After 30 minutes if remnants of the tablet still remain, patients may swallow it with a glass of water. 13. Patients must be cautioned to talk to their doctor if breakthrough pain is not alleviated or worsens after taking FENTORA. 14. Patients must be instructed to use FENTORA exactly as prescribed by their doctor and not to take FENTORA more often than prescribed. 15. Patients must be cautioned that FENTORA can affect a person s ability to perform activities that require a high level of attention (such as driving or using heavy machinery). Patients taking FENTORA should be warned of these dangers and counseled accordingly. 16. Patients must be warned to not combine FENTORA with alcohol, sleep aids, or tranquilizers except by the orders of the prescribing physician, because dangerous additive effects may occur, resulting in serious injury or death. 17. Female patients must be informed that if they become pregnant or plan to become pregnant during treatment with FENTORA, they should ask their doctor about the effects that FENTORA (or any medicine) may have on them and their unborn children. 18. Patients and caregivers must be advised that if they have been receiving treatment with FENTORA and the medicine is no longer needed they should flush any remaining product down the toilet, and if they then need further assistance, contact Cephalon at Laboratory Tests: The effects of FENTORA on laboratory tests have not been evaluated. Drug Interactions: See WARNINGS. Fentanyl is metabolized mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4); therefore potential interactions may occur when FENTORA is given concurrently with agents that affect CYP3A4 activity. The concomitant use of FENTORA with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, and nefazadone) or moderate CYP3A4 inhibitors (e.g., amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, and verapamil) may result in increased fentanyl plasma concentrations, potentially causing serious adverse drug effects including fatal respiratory depression. Patients receiving FENTORA concomitantly with moderate or strong CYP3A4 inhibitors should be carefully monitored for an extended period of time. Dosage increase should be done conservatively. (See PHARMACOKINETICS, Drug Interactions and DOSAGE AND ADMINISTRATION.) Grapefruit and grapefruit juice decrease CYP3A4 activity, increasing blood concentrations of fentanyl, thus should be avoided. Drugs that induce cytochrome P450 3A4 activity may have the opposite effects. Concomitant use of FENTORA with an MAO inhibitor, or within 14 days of discontinuation, is not recommended. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term studies in animals have not been performed to evaluate the carcinogenic potential of fentanyl. Fentanyl citrate was not mutagenic in the in vitro Ames reverse mutation assay in S. tymphimurium or E. coli, or the mouse lymphoma mutagenesis assay. Fentanyl citrate was not clastogenic in the in vivo mouse micronucleus assay. Fentanyl impairs fertility in rats at doses of 30 mcg/kg IV and 160 mcg/kg SC. Conversion to human equivalent doses indicates this is within the range of the human recommended dosing for FENTORA. Pregnancy - Category C: There are no adequate and well-controlled studies in pregnant women. FENTORA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. No epidemiological studies of congenital anomalies in infants born to women treated with fentanyl during pregnancy have been reported. Chronic maternal treatment with fentanyl during pregnancy has been associated with transient respiratory depression, behavioral changes, or seizures characteristic of neonatal abstinence syndrome in newborn infants. Symptoms of neonatal respiratory or neurological depression were no more frequent than expected in most studies of infants born to women treated acutely during labor with intravenous or epidural fentanyl. Transient neonatal muscular rigidity has been observed in infants whose mothers were treated with intravenous fentanyl. Fentanyl is embryocidal as evidenced by increased resorptions in pregnant rats at doses of 30 mcg/kg IV or 160 mcg/kg SC. Conversion to human equivalent

78 doses indicates this is within the range of the human recommended dosing for FENTORA. Fentanyl citrate was not teratogenic when administered to pregnant animals. Published studies demonstrated that administration of fentanyl (10, 100, or 500 mcg/kg/day) to pregnant rats from day 7 to 21, of their 21 day gestation, via implanted microosmotic minipumps was not teratogenic (the high dose was approximately 3-times the human dose of 1600 mcg per pain episode on a mg/m 2 basis). Intravenous administration of fentanyl (10 or 30 mcg/kg) to pregnant female rats from gestation day 6 to 18, was embryo or fetal toxic, and caused a slightly increased mean delivery time in the 30 mcg/kg/day group, but was not teratogenic. Labor and Delivery: Fentanyl readily passes across the placenta to the fetus; therefore FENTORA is not recommended for analgesia during labor and delivery. Nursing Mothers: Fentanyl is excreted in human milk; therefore FENTORA should not be used in nursing women because of the possibility of sedation and/or respiratory depression in their infants. Symptoms of opioid withdrawal may occur in infants at the cessation of nursing by women using FENTORA. Pediatric Use: See WARNINGS. Geriatric Use: Of the 304 patients with cancer in clinical studies of FENTORA, 69 (23%) were 65 years of age and older. Patients over the age of 65 years tended to titrate to slightly lower doses than younger patients. Patients over the age of 65 years reported a slightly higher frequency for some adverse events specifically vomiting, constipation, and abdominal pain. Therefore, caution should be exercised in individually titrating FENTORA in elderly patients to provide adequate efficacy while minimizing risk. ADVERSE REACTIONS Pre-Marketing Clinical Trial Experience: The safety of FENTORA has been evaluated in 304 opioid tolerant cancer patients with breakthrough pain. The average duration of therapy was 76 days with some patients being treated for over 12 months. The most commonly observed adverse events seen with FENTORA are typical of opioid side effects. Opioid side effects should be expected and managed accordingly. The clinical trials of FENTORA were designed to evaluate safety and efficacy in treating patients with cancer and breakthrough pain; all patients were taking concomitant opioids, such as sustained-release morphine, sustained-release oxycodone or transdermal fentanyl, for their persistent pain. The adverse event data presented here reflect the actual percentage of patients experiencing each adverse effect among patients who received FENTORA for breakthrough pain along with a concomitant opioid for persistent pain. There has been no attempt to correct for concomitant use of other opioids, duration of FENTORA therapy or cancer-related symptoms. Table 5 lists, by maximum dose received, adverse events with an overall frequency of 5% or greater within the total population that occurred during titration. The ability to assign a dose-response relationship to these adverse events is limited by the titration schemes used in these studies. Table 5. Adverse Events Which Occurred During Titration at a Frequency of 5% System Organ Class 100 mcg 200 mcg 400 mcg 600 mcg 800 mcg Total MeDRA preferred (N=45) (N=34) (N=53) (N=56) (N=113) (N=304)* term, n (%) Gastrointestinal disorders Nausea 4 (9) 5 (15) 10 (19) 13 (23) 18 (16) 50 (17) Vomiting 0 2 (6) 2 (4) 7 (13) 3 (3) 14 (5) General disorders and administration site conditions Fatigue 3 (7) 1 (3) 9 (17) 1 (2) 5 (4) 19 (6) Nervous system disorders Dizziness 5 (11) 2 (6) 12 (23) 18 (32) 21 (19) 58 (19) Somnolence 2 (4) 2 (6) 6 (12) 7 (13) 3 (3) 20 (7) Headache 1 (2) 3 (9) 4 (8) 8 (14) 10 (9) 26 (9) * Three hundred and two (302) patients were included in the safety analysis. Table 6 lists, by successful dose, adverse events with an overall frequency of 5% within the total population that occurred after a successful dose had been determined. Table 6. Adverse Events Which Occurred During Long-Term Treatment at a Frequency of 5% System Organ Class 100 mcg 200 mcg 400 mcg 600 mcg 800 mcg Total MeDRA preferred (N=19) (N=31) (N=44) (N=48) (N=58) (N=200) term, n (%) Blood and lymphatic system disorders Anemia 6 (32) 4 (13) 4 (9) 5 (10) 7 (13) 26 (13) Neutropenia 0 2 (6) 1 (2) 4 (8) 4 (7) 11 (6) Gastrointestinal disorders Nausea 8 (42) 5 (16) 14 (32) 13 (27) 17 (31) 57 (29) Vomiting 7 (37) 5 (16) 9 (20) 8 (17) 11 (20) 40 (20) Constipation 5 (26) 4 (13) 5 (11) 4 (8) 6 (11) 24 (12) Diarrhea 3 (16) 0 4 (9) 3 (6) 5 (9) 15 (8) Abdominal pain 2 (11) 1 (3) 4 (9) 7 (15) 4 (7) 18 (9) General disorders and administration site conditions Edema peripheral 6 (32) 5 (16) 4 (9) 5 (10) 3 (5) 23 (12) Asthenia 3 (16) 5 (16) 2 (5) 3 (6) 8 (15) 21 (11) Fatigue 3 (16) 3 (10) 9 (20) 9 (19) 8 (15) 32 (16) Infections and infestations Pneumonia 1 (5) 5 (16) 1 (2) 1 (2) 4 (7) 12 (6) Investigations Weight decreased 1 (5) 1 (3) 3 (7) 2 (4) 6 (11) 13 (7) Metabolism and nutrition disorders Dehydration 4 (21) 0 4 (9) 6 (13) 7 (13) 21 (11) Anorexia 1 (5) 2 (6) 4 (9) 3 (6) 6 (11) 16 (8) Hypokalemia 0 2 (6) 0 1 (2) 8 (15) 11 (6) Musculoskeletal and connective tissue disorders Back pain 2 (11) 0 2 (5) 3 (6) 2 (4) 9 (5) Arthralgia 0 1 (3) 3 (7) 4 (8) 3 (5) 11 (6) Neoplasms benign, malignant and unspecified (including cysts and polyps) Cancer pain 3 (16) 1 (3) 3 (7) 2 (4) 1 (2) 10 (5) Nervous system disorders Dizziness 5 (26) 3 (10) 5 (11) 6 (13) 6 (11) 25 (13) Headache 2 (11) 1 (3) 4 (9) 5 (10) 8 (15) 20 (10) Somnolence 0 1 (3) 4 (9) 4 (8) 8 (15) 17 (9) Psychiatric disorders Confusional state 3 (16) 1 (3) 2 (5) 3 (6) 5 (9) 14 (7) Depression 2 (11) 1 (3) 4 (9) 3 (6) 5 (9) 15 (8) Insomnia 2 (11) 1 (3) 3 (7) 2 (4) 4 (7) 12 (6) Respiratory, thoracic, and mediastinal disorders Cough 1 (5) 1 (3) 2 (5) 4 (8) 5 (9) 13 (7) Dyspnea 1 (5) 6 (19) 0 7 (15) 4 (7) 18 (9) In addition, a small number of patients (n=11) with Grade 1 mucositis were included in clinical trials designed to support the safety of FENTORA. There was no evidence of excess toxicity in this subset of patients. The duration of exposure to FENTORA varied greatly, and included open-label and double-blind studies. The frequencies listed below represent 1% of patients from 3 clinical trials who experienced that event while receiving FENTORA. Events are classified by system organ class. Adverse Events ( 1%): Blood and Lymphatic System Disorders: Anemia, Neutropenia, Thrombocytopenia, Leukopenia; Cardiac Disorders: Tachycardia; Gastrointestinal Disorders: Nausea, Vomiting, Constipation, Abdominal Pain, Diarrhea, Stomatitis, Dry Mouth, Dyspepsia, Upper Abdominal Pain, Abdominal Distension, Dysphagia, Gingival Pain, Stomach Discomfort, Gastroesophageal Reflux Disease, Glossodynia, Mouth Ulceration; General Disorders and Administration Site Conditions: Fatigue, Edema Peripheral, Asthenia, Pyrexia, Application Site Pain, Application Site Ulcer, Chest Pain, Chills, Application Site Irritation, Edema, Mucosal Inflammation, Pain; Hepatobiliary Disorders: Jaundice; Infections and Infestations: Pneumonia, Oral Candidiasis, Urinary Tract Infection, Cellulitis, Nasopharyngitis, Sinusitis, Upper Respiratory Tract Infection, Influenza, Tooth Abscess; Injury, Poisoning and Procedural Complications: Fall, Spinal Compression Fracture; Investigations: Decreased Weight, Decreased Hemoglobin, Increased Blood Glucose, Decreased Hematocrit, Decreased Platelet Count; Metabolism and Nutrition Disorders: Dehydration, Anorexia, Hypokalemia, Decreased Appetite, Hypoalbuminemia, Hypercalcemia, Hypomagnesemia, Hyponatremia, Reduced Oral Intake; Musculoskeletal and Connective Tissue Disorders: Arthralgia, Back Pain, Pain in Extremity, Myalgia, Chest Wall Pain, Muscle Spasms, Neck Pain, Shoulder Pain; Nervous System Disorders: Dizziness, Headache, Somnolence, Hypoesthesia, Dysgeusia, Lethargy, Peripheral Neuropathy, Paresthesia, Balance Disorder, Migraine, Neuropathy; Psychiatric Disorders: Confusional State, Depression, Insomnia, Anxiety, Disorientation, Euphoric Mood, Hallucination, Nervousness; Renal and Urinary Disorders: Renal Failure; Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, Cough, Pharyngolaryngeal Pain, Exertional Dyspnea, Pleural Effusion, Decreased Breathing Sounds, Wheezing; Skin and Subcutaneous Tissue Disorders: Pruritus, Rash, Hyperhidrosis, Cold Sweat; Vascular Disorders: Hypertension, Hypotension, Pallor, Deep Vein Thrombosis OVERDOSAGE Clinical Presentation: The manifestations of FENTORA overdosage are expected to be similar in nature to intravenous fentanyl and other opioids, and are an extension of its pharmacological actions with the most serious significant effect being hypoventilation. General: Immediate management of opioid overdose includes removal of the FENTORA tablet, if still in the mouth, ensuring a patent airway, physical and verbal stimulation of the patient, and assessment of level of consciousness, as well as ventilatory and circulatory status. Treatment of Overdosage in the Opioid Non-Tolerant Person: Ventilatory support should be provided, intravenous access obtained, and naloxone or other opioid antagonists should be employed as clinically indicated. The duration of respiratory depression following overdose may be longer than the effects of the opioid antagonist s action (e.g., the half-life of naloxone ranges from 30 to 81 minutes) and repeated administration may be necessary. Consult the package insert of the individual opioid antagonist for details about such use. Treatment of Overdose in Opioid-Tolerant Patients: Ventilatory support should be provided and intravenous access obtained as clinically indicated. Judicious use of naloxone or another opioid antagonist may be warranted in some instances, but it is associated with the risk of precipitating an acute withdrawal syndrome. General Considerations for Overdose: Management of severe FENTORA overdose includes: securing a patent airway, assisting or controlling ventilation, establishing intravenous access, and GI decontamination by lavage and/or activated charcoal, once the patient s airway is secure. In the presence of hypoventilation or apnea, ventilation should be assisted or controlled and oxygen administered as indicated. Patients with overdose should be carefully observed and appropriately managed until their clinical condition is well controlled. Although muscle rigidity interfering with respiration has not been seen following the use of FENTORA, this is possible with fentanyl and other opioids. If it occurs, it should be managed by the use of assisted or controlled ventilation, by an opioid antagonist, and as a final alternative, by a neuromuscular blocking agent. DOSAGE AND ADMINISTRATION Physicians should individualize treatment using a progressive plan of pain management. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring. (See BOXED WARNING and Dosing.) It is important to minimize the number of strengths available to patients at any time to prevent confusion and possible overdose. Dosing 1. Initial dose a. For opioid-tolerant patients not being converted from Actiq, the initial dose of FENTORA is always 100 mcg. b. For patients being converted from Actiq, prescribers must use the Initial Dosing Recommendations table below (Table 7). The doses of FENTORA in this table are starting doses and not intended to represent equianalgesic doses to Actiq. Patients must be instructed to stop the use of Actiq and dispose of any remaining units. Table 7. Initial Dosing Recommendations for Patients on Actiq Current Actiq Dose (mcg) Initial FENTORA Dose (mcg) mcg tablet mcg tablet mcg tablet mcg tablet x 200 mcg tablets x 200 mcg tablets c. For patients converting from Actiq doses equal to or greater than 600 mcg, titration should be initiated with the 200 mcg FENTORA tablet and should proceed using multiples of this tablet strength. d. In cases where the breakthrough pain episode is not relieved after 30 minutes, patients may take ONLY ONE additional dose using the same strength for that episode. Thus patients should take a maximum of two doses of FENTORA for any episode of breakthrough pain. e. Patients MUST wait at least 4 hours before treating another episode of breakthrough pain with FENTORA. 2. Titration a. From an initial dose, patients should be closely followed by the prescriber and the dosage strength changed until the patient reaches a dose that provides adequate analgesia with tolerable side effects. Patients should record their use of FENTORA over several episodes of breakthrough pain and discuss their experience with their physician to determine if a dosage adjustment is warranted. b. Patients whose initial dose is 100 mcg and who need to titrate to a higher dose, can be instructed to use two 100-mcg tablets (one on each side of the mouth in the buccal cavity) with their next breakthrough pain episode. If this dosage is not successful, the patient may be instructed to place two 100-mcg tablets on each side of the mouth in the buccal cavity (total of four 100 mcg tablets). Titrate using multiples of the 200-mcg FENTORA tablet for doses above 400 mcg (600 mcg and 800 mcg) Note: Do not use more than 4 tablets simultaneously. c. In cases where the breakthrough pain episode is not relieved after 30 minutes, patients may take ONLY ONE additional dose of the same strength for that episode. Thus patients should take a maximum of two doses of FENTORA for any breakthrough pain episode. During titration, one dose of FENTORA may include administration of 1 to 4 tablets of the same dosage strength (100 mcg or 200 mcg). d. Patients MUST wait at least 4 hours before treating another episode of breakthrough pain with FENTORA. To reduce the risk of overdose during titration, patients should have only one strength of FENTORA tablets available at any one time. e. Patients should be strongly encouraged to use all of their FENTORA tablets of one strength prior to being prescribed the next strength. If this is not practical, unused FENTORA should be disposed of safely. (See DISPOSAL OF FENTORA.) Dispose of any unopened FENTORA tablets remaining from a prescription as soon as they are no longer needed. 3. Maintenance Dosing a. Once titrated to an effective dose, patients should generally use only ONE FENTORA tablet of the appropriate strength per breakthrough pain episode. b. On occasion when the breakthrough pain episode is not relieved after 30 minutes, patients may take ONLY ONE additional dose using the same strength for that episode. c. Patients MUST wait at least 4 hours before treating another episode of breakthrough pain with FENTORA. d. Dosage adjustment of FENTORA may be required in some patients in order to continue to provide adequate relief of breakthrough pain. Generally, the FENTORA dose should be increased only when a single administration of the current dose fails to adequately treat the breakthrough pain episode for several consecutive episodes. If the patient experiences greater than four breakthrough pain episodes per day, the dose of the maintenance (aroundthe-clock) opioid used for persistent pain should be re-evaluated. Patients with hepatic and/or renal impairment: Caution should be exercised for patients with hepatic and/or renal impairment, and the lowest possible dose should be used in these patients. (See PRECAUTIONS.) Patients receiving CYP3A4 inhibitors: Particular caution should be exercised for patients receiving CYP3A4 inhibitors, and the lowest possible dose should be used in these patients. (See PRECAUTIONS.)

79 Patients with mucositis: No dose adjustment appears necessary in patients with Grade 1 mucositis. The safety and efficacy of FENTORA when used in patients with mucositis more severe than Grade 1 have not been studied. Opening the Blister Package 1. Patients should be instructed not to open the blister until ready to administer FENTORA. 2. A single blister unit should be separated from the blister card by bending and tearing apart at the perforations. 3. The blister unit should then be bent along the line where indicated. 4. The blister backing should then be peeled back to expose the tablet. Patients should NOT attempt to push the tablet through the blister as this may cause damage to the tablet. 5. The tablet should not be stored once it has been removed from the blister package as the tablet integrity may be compromised and, more importantly, because this increases the risk of accidental exposure to the tablet. Tablet Administration: Once the tablet is removed from the blister unit, the patient should immediately place the entire FENTORA tablet in the buccal cavity (above a rear molar, between the upper cheek and gum). Patients should not attempt to split the tablet. The FENTORA tablet should not be sucked, chewed or swallowed, as this will result in lower plasma concentrations than when taken as directed. The FENTORA tablet should be left between the cheek and gum until it has disintegrated, which usually takes approximately minutes. After 30 minutes, if remnants from the FENTORA tablet remain, they may be swallowed with a glass of water. It is recommended that patients alternate sides of the mouth when administering subsequent doses of FENTORA. SAFETY AND HANDLING FENTORA is supplied in individually sealed, child-resistant blister packages. The amount of fentanyl contained in FENTORA can be fatal to a child. Patients and their caregivers must be instructed to keep FENTORA out of the reach of children. (See BOXED WARNING, WARNINGS, PRECAUTIONS, and MEDICATION GUIDE.) Store at 20-25ºC (68-77ºF) with excursions permitted between 15 and 30 C (59 to 86 F) until ready to use. (See USP Controlled Room Temperature.) FENTORA should be protected from freezing and moisture. Do not use if the blister package has been tampered with. DISPOSAL OF FENTORA Patients and members of their household must be advised to dispose of any tablets remaining from a prescription as soon as they are no longer needed. Information is available in Information for Patients and Caregivers and in the Medication Guide. If additional assistance is required, referral to the Cephalon 800# ( ) should be made. To dispose of unused FENTORA, remove FENTORA tablets from blister packages and flush down the toilet. Do not flush FENTORA blister packages or cartons down the toilet. If you need additional assistance with disposal of FENTORA, call Cephalon, Inc., at HOW SUPPLIED Each carton contains 7 blister cards with 4 white tablets in each card. The blisters are child resistant, encased in peelable foil, and provide protection from moisture. Each tablet is debossed on one side with, and the other side of each dosage strength is uniquely identified by the debossing on the tablet. The dosage strength of each tablet is marked on the tablet, the blister package and the carton. See blister package and carton for product information. Note: Carton/blister package colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing. Manufactured for: Cephalon, Inc. Frazer, PA By: CIMA LABS, INC. Cephalon, Inc Valley View Road and 4745 Wiley Post Way Eden Prairie, MN Salt Lake City, UT U. S. Patent Nos. 6,200,604 and 6,974,590 Printed in USA FENT Cephalon, Inc. All rights reserved.

80 To learn more about FENTORA, visit the Cephalon, Inc. booth FENTORA matches the sudden strike of breakthrough pain in some opioid tolerant patients with cancer Onset of pain relief within 15 minutes (first time point measured) 1,2 Duration of relief up to 60 minutes (last time point measured) 1,2 Serious adverse events associated with all opioids are respiratory depression (potentially leading to apnea or respiratory arrest), circulatory depression, hypotension, and shock. All patients should be followed for symptoms of respiratory depression. In FENTORA cancer trials, the most frequently occurring adverse events ( 10% of patients in either titration or posttitration) were nausea, vomiting, fatigue, dizziness, anemia, constipation, peripheral edema, dehydration, asthenia, and headache. No corrections were made for concomitant use of around-the-clock opioids or cancer-related symptoms. In addition, application site reactions, which occurred in 10% of patients in all FENTORA studies, tended to occur early in treatment, were self-limited, and resulted in treatment discontinuation for only 2% of patients. PHYSICIANS AND OTHER HEALTHCARE PROVIDERS MUST BECOME FAMILIAR WITH THE IMPORTANT WARNINGS IN THIS LABEL. Reports of serious adverse events, including deaths in patients treated with FENTORA have been reported. Deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients) and/or improper dosing. The substitution of FENTORA for any other fentanyl product may result in fatal overdose. FENTORA is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid daily for a week or longer. FENTORA is not indicated for use in opioid non-tolerant patients including those with only as needed (PRN) prior exposure. FENTORA is contraindicated in the management of acute or postoperative pain including headache/migraine. Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients. When prescribing, do not convert patients on a mcg per mcg basis from Actiq to FENTORA. Carefully consult the Initial Dosing Recommendations table. (See DOSAGE AND ADMINISTRATION, Table 7.) When dispensing, do not substitute a FENTORA prescription for other fentanyl products. Substantial differences exist in the pharmacokinetic profile of FENTORA compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of FENTORA for any other fentanyl product may result in fatal overdose. Special care must be used when dosing FENTORA. If the breakthrough pain episode is not relieved after 30 minutes, patients may take ONLY one additional dose using the same strength and must wait at least 4 hours before taking another dose. (See DOSAGE AND ADMINISTRATION.) FENTORA contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. FENTORA can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing FENTORA in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Patients and their caregivers must be instructed that FENTORA contains a medicine in an amount which can be fatal to a child. Patients and their caregivers must be instructed to keep all tablets out of the reach of children. (See Information for Patients and Caregivers for disposal instructions.) FENTORA is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain. The concomitant use of FENTORA with strong and moderate cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression. For more information about FENTORA, please call Cephalon Medical Services at or visit Please see boxed warning and brief summary of prescribing information on adjacent pages. References: 1. Portenoy RK, Taylor D, Messina J, Tremmel L. A randomized, placebo-controlled study of fentanyl buccal tablet for breakthrough pain in opioid-treated patients with cancer. Clin J Pain. 2006;22(9): FENTORA [package insert]. Frazer, PA: Cephalon, Inc.; Cephalon, Inc. All rights reserved. FENT232b Mar 2008 Printed in USA.