Jnging the Face of Pain Management 12 Complementary and Alternative Medicine 19 Practical Aspects in Pelvic Pain Treatrr

Jnging the Face of Pain Management 12 Complementary and Alternative Medicine 19 Practical Aspects in Pelvic Pain Treatrr t You Eat: Managing Chronic Pain 14 Treating Post-deployment Chronic Pain 20 Talk on Analgesia Explores New ossification and Treatments: Master Class in Challenging Populations 18 Chronic Pain Problems Among the Medically Underserved 22 Appraoches to Pain Management Taking a Better Look at Drug Interad Ig the Concept of the Integrated linic Means Demonstrating Verifiable Icy rry approach to pain management produces the best outcomes for patients. Clinicians who this approach must avoid repeating the mistakes of the past and concentrate on providing service. Discrepant Goals in Pain int: Strategies for Balancing rsician, and Other r Needs" (SIS-19) ice' E. Schatman, PhD, CPE, DASPE y, September 8 1- 12:10pm al 4, Mont-Royal Ballroom rdisciplinary pain dinics are an endangered patient numbers keep dwindling, and their Ming, all because financial considerations of- elfare. ernment would compel hospitals to main- rce insurers to cover treatment, says Mi- 1, PhD, CPE, DASPE, Executive Director of r Ethics in Pain Care. Until such mandates Schatrnan. "This strategy works because interdisciplinary pain management really does help nearly all stakeholders. The trick is learning to demonstrate that: To ilustrate the challenges pain specialists face, Schatrnan will start by tracing the sad decline of interdisciplinary pain manage- ment and explaining why a nation that had more than 1,000 integrated drics in 1998 has fewer than 100 today. Integrated pain management clinics initially opened, both inside hospitals and independently, because researchers consis- tently found that coordinated teams of complementary pain spe- cialists—usually a physician, a psychologist, a physical therapist, a nurse practitioner, and possibly several others—provide the best care for serious chronic pain. Indeed, the research looked so good that insurers became (by their standards) positively enthusiastic about pain clinics, many of which responded to the easy money by adding services and padding bills. Worse, the flow of insurance money inspired under- qualified (and occasionally dodgy) practitioners to open their own clinics to make a quick buck. Costs rose. Outcomes worsened. Insurers began slashing reimbursement rates and dropping coverage altogether. Clin- rs to see things from the other rspective and show how he benefits or desired course of action. This works because interdisciplinary nagement really does help nearly holders. The trick is learning to rate that. RECAP Research into the Intl of Music and Neuroi tion May Unlock Nel Treatments New data is demonstrating the heali of music and suggesting new applica management everal presentations during PAINWeek Stny the ways in which the brain interacts 1 , pail. On Tuesday, Michael B. Elko. Daniel F. Cleary presented on the ways ii Ali can help to aleviate pero. On Wednesday, Reb spoke about how our brains can be positively pail differently. The trend contrwed Friday n tin by Maio J. Trans, MD, PhD, Director Insi Brain Science; Department of Neurology, Dc of Medicine at UCLA. Fis presentation, 'The Nesomodulation of Pain Responses," provided how the human brain processes sound.VVhileT adze in the management of pain, he has pa studies that have examined the correlation b that way it inpads our bodies. Tramo began by telling the audience tha: sic as a healing power dates bock thousand! mythology, Apollo was associated with both Asclepius, a Greek god of healing, was belie. help rid sick patients of their disease. While tl cal figures, the fact is that there have been anecdotal reports over the centuries about tio ameliorate pain and suffering across a wide eases, and clinical settings. Yes, it is important when dealing with any kind of anecdotal dc some of these recounted experiences have I- study of the correlation of music and healing There is also a growing body of evidence ized-controlled trials demonstrating music's of agement, said Tramo. He went on to discus ing the pathways by which the brain proces that, basically, our brains have an auditory N (con over, Schatman has some advice for cli- to revive the integrated pain program, ore today at PAINWeek 2012 during his ics began losing money. Then many of them shut their doors. Needlessly, according to Schatman. "Patients suffered because everyone got greedy," Schatman Experience the expanded Living Bey a "multimedia showcase that presen EFTA01114703 r rain management in America )ents touch on all aspects of the delivery of quality pain care—from the research laboratory to ambers across the nation. the exam room, from the courtroom ents in Law and Public ications for Pain Care 3" (SIS-20) mei C. Barnes, JD y, September 8 20pm ≥I 4, Mont-Royal Ballroom nth isn't the only thing that will change how ciafists treat patients in the upcoming year. •ange of recent legal, financial, and cultural an more to affect standards of care. nes, JD, managing partner of DCBA Law Igton, will outline the most relevant recent n what they could mean for pain clinicians in his presentation this evening, "Current d Public Policy: Implications for Pain Care legislators, regulators, and journalists have terested in pain management recently, and iuch in the past year to exercise their power is and their patients. are starting to worry about prescription drug abuse. He says that "Pain specialists may think they can't possibly hear any more about the dangers of opioid abuse, but they haven't heard anything yet. The issue has finally reached a tipping point in terms of mainstream media coverage, which means coverage will perpetuate itself, probably until the problem is 'solved" in the public mind. Barnes notes that in the past year or two, "nearly every major newspaper in America has published articles highlighting the fact that prescription opioid overdoses kill more people each year than car crashes in some states," along with other now-familiar factoids about the effects of pre- scription opioid abuse and misuse. In the wake of these news reports, celebrity overdoses continuing to make headlines, and sensational media accounts of "addicted babies: Barnes says that "we've already seen an uptick in opioid-related legislation, regulation, litigation, and prosecution. And more is coming. Probably a lot more: Another important trend is that pain advocacy groups are losing funding and power. Barnes says that concerns about the opioid abuse problem were already deterring donors, even before this year's public relations nightmare in which investiga- tions shined a spotlight on the close ties between some phar- maceutical companies and advocacy groups. Oddly, these in- vestigations come just as drug makers—worried that efforts to curtail opioid abuse will slash overall sales and profits—are cut- ting expenditures on pain advocacy. Pain advocacy groups are thus losing money from all sides at the very moment when their Pain specialists may think they can't possibly hear any more about the dangers of opioid abuse, but they haven't heard anything yet. The issue has finally reached a tipping point in terms of mainstream media coverage. potentially influential events is huge: hun- •ds each year, certainly: says Barnes. "The sense of them is to look for trends, and I've nes that people who treat pain really should inderstand: iccording to Barnes, is that more Americans message about the importance of treating pain is falling out of favor. As a consequence, Barnes warns that pain specialists and advocates could see their ability to influence legislatures, insurers, and the public decline. Addiction treatment may become a major component of pain care. Because their expertise would, in theory, allow them to spot opioid abuse (or even potential abu patients overcome any problems that develc selors strike many as a natural fit for pain ilia few insurers cover addiction treatment, whi a non-starter, until the Affordable Care Ac law mandates coverage for addiction treatn financially feasible opportunities for pain p to serve patients better (and, potentially, r ity), either by hiring their own counselors or I third-party treatment programs. "Most of the people in the audience prob to like hearing most of what I have to say," Bc is different. This is a real opportunity for care The greater legal risks faced by dinicians oids "too freely" is another trend that should attendees, says Barnes. Criminal prosecutions mills and "careless" practitioners are on the California stood trial for second-degree murd patients overdosed. The local DA argued that ment that there was nothing she could do tc from taking a month's worth of pills in one da ful omission, and thus justified the murder chc Civil suits are dso on the rise, both against dc companies. In one case, a family landed survh workers compensation policy after their relative opioids for an on-the-job story overdosed. Insu ginreig to increase restrictions on coverage of c According to Barnes, tamper-resistant op make-or-break moment. This is an issue becc studies suggest that new formulations do inc often quite dramatically —financial considerati from the market unless the government mand become tamper resistant. Today's tamper re are more expensive, branded products. Man pay for them, and most generic drug maker licensing fees to make their products tamper t Finally, Barnes says that clinicians who pn soon need extra training courses. A couple ready mandated new educational prograrr prescribes controlled substances. Many oche ering it, as is the US Congress. "The first trend — growing public concern drug abuse — underlies all the others," Barnes bly drive more changes to the industry than a ued from cover) 4 respond to or get excited by sound. Based terprets these sounds, our body gives a natural had the experience of going to the dentist and g 11 our teeth. How many of us have grabbed clenched our hands to try and decrease the rt we are having in our mouths? Any of us who evoking the gate theory for pain. We are alo-observe the effects in a controlled environment. Although it was a small-scale study (seven control babies, seven test babies), Tramo said it prodcued some interesting results. The music "created a lot of stabiTrty and lowered the blood pressure of those infants that it was played for: Although only two of the four babies who had not heard the music stopped crying following the heel stidc, all four infants who hod been able to hear the music stopped crying. Tramo told the audience to keep an eye on a relatively new journal EFTA01114704 UPIWeek: e to the fourth and final day of the conference. hedule today features the four sessions of this Complementary and Alternative Medicine presentation that focus on pain medicine nurs- resented by pain management experts from the *ion, the second half of the pharmacotherapy lule also includes a trio of sessions on regional cluing pelvic pain, arm and hand pain, and ("phantom tooth pain"). The Special Interest cover topics in pharmacy-based pain services, ferences in pain management, new develop- Kiblic policy, and the influence of various pain ',alders on the physician-patient relationship. it 7:00am with Hal S. Blatman, MD, present- thition aid pain that will explain the ways in s in our patients' diets actually stop their bod- nd get in the way of rehabilitation? Blatman ecific nutrients that will augment healing and/ luce pain? Debra J. Drew, MS, ACNS-BC, ie the challenges associated with pain assess- care setting, especially in special populations. sr, Phenyl!), BCPS, will give a talk on phar- pharmacokinetic pain and paVia- M. Fitzgerald, e epidemiology le chronic pelvic s in pathophysi- diagnosis, and s and treatment irome. ert A. Bonak- iew the preva- nd most con- 'pies as well as ne patient con- complementary spies in pain management. Helen N. Turner, 4S-BC, on the use of multimodal analgesia in She will also cover various nonpharmaceuticol to be effective additions to multimodal pain McPherson, Phenyl!), BCPS, will elucidate cokinetic and phormacodynamic properties of mysterious methadone," covering a range of propriate titration strategies as well as how to inverted from another drug to methadone? first of three satellite programs scheduled for 'atients and Your Practice: The Role of Drug pin and Risk Management," sponsored by Alere hire Jennifer E. Bolen, JD, and Jeffery A. issing practical approaches to incorporating comprehensive chronic pain and risk manage- theft A. Bonakdar, MD, continues the id Alternative Medicine track with "Overview Dietary Supplements," during which he will ace of supplement use in specific pain condi-medication facts." Roger B. Fillingim, PhD, will discuss sex and gender differences in pain management and explore possible answers to the question "Do we need pink and blue pills?" Cam-Ann Gibson, MD, and Ilene R. Robeck, MD, will exam- ine key topics and challenges in evaluating and treating chronic pain in veterans following deployment. Following the morning break, at 11:10am, Lora McGuire, MS, RN, will explore topics in the management of postoperative pain, induding preemptive analgesia, special methods of delivery of pain control, and nonopioid, opioid, and adjuvant analgesics. Srinivas Nalamachu, MD, will discuss the clinical characteris- tics, assessment diagnosis, and treatment of arm aid hand pain. Michael E. Schatrrtan, PhD, will talk about the evolving influence of non-patient and non-physician stakeholders in pain management (insurance, hospital, pharmaceutical, implantable device, and urine drug testing industries, etc) and explain why these various actors must coalesce into a "mutually cooperative system' if the suffering of pain patients is to be ameliorated. At 12:30pm, the schedule features the final two satellite events of PAINWeek 2012. The faculty of "Persistent and Breakthrough Pain: Responsible Opioid Prescribing for Multidimensional Disorders" will consolidate clinically relevant scientific studies and evidence-based guidelines into practical approaches to persistent pain and break- through pain assessment, responsible opioid prescrib- ing, and repeated re-eval- uation of patient outcomes. "Mission: Pain Management - The Efficient First Visit (An IDEAL® Clinical Encounter)" v/il discuss nociceptive, neu- ropathic, and centrally-me- diated chronic pain; the risks and benefits of nonpharma- cologic and pharmacologic treatments for chronic pain; barriers to the optimal use of opioid analgesics in chronic pain; and methods for screening and risk miti- gation in the initial and follow-up care of patients with chronic pain. At 2:10pm, Hal S. Blatman, MD, will present "a wide range of options for treatment, recovery, and body maintenance fa a healthy aid pain-free life" for women at midge. Bill Paquin, CEO of Vertical Health, will explore "the pivotal role that Web aid mobile applications wi ploy to both increase the efficiency of physician practices and improve patient outcomes" in pain management. Edward S. Lee, MD, and Tu A. Ngo, PhD, MPH, will offer a plenary session focus- ing on managing psychiatric comorbidties in chronic pain. Gary W. Jay, MD, will present a master class on the differential diagnosis and management of migrare and tension-type headache. Following the afternoon break, Carol P. Curtiss, MSN, RN-BC, will discuss key principles involved in balancing effective pain management and saeening for risk of substance misuse and addiction in persons with pain. Peter A. Foreman, DDS, will examine the difficult diagnostic and treatment challenges associated with orofacial neuropathies. Mary Lynn McPherson, PharmD, and Kathryn A. Walker, PharmD, will duke it out as Today's Schedule of Recommended Cou for First-time PAINVI Attendees 7:OOam-8:OOam Nutrition and Pain: Simple R for Pain-Free Health Hal S. Blatman, MD 7:OOam-8:OOam Pelvic Pain Colleen M. Fitzgerald, MD 8:10am-9:10am Analgesia: What are the Op Helen N. Turner, DNP, RN-BC, PCN 9:20am-10:20am Speed Dating with Pharmaci 50 Top Medication Tips at Er Mary Lynn McPherson, PharmD, BC Kathryn A. Walker, PharmD, BCPS 11:10am-12:10pm Pre- and Postop Pain Manag Lora McGuire, MS, RN 2:10pm-3:10pm Women on the Verge: Sleep, and Pain at Midlife Hal S. Blatman, MD 5:20pm-6:20pm VA Health Care: This is Not Your Father's VA Lucile Burgo-Black, MD, and Stephi MD, MPH EFTA01114705 rTeCT In leOTIenTS IGKIng Up10105 nor is Pain 'WV wescribe opioids should be aware of the symptoms of opioid-induced constipation of the pharmacologic options for managing this condition goid-kiduced Constipation: Considerations to 'propriate Early Targeted Therapy for Better Pa- ernes," a CME-accredited session yesterday at at focused on opioid-induced constipation, its and the pharmacologic options that are co- rrect this condition, presenters Bil McCarberg, O; and Michelle Rhiner, RN-BC, MSN, provided motion that clinicians can apply to daily practice. e session by talking about the scope of the induced constipation (OIC). Because prescrip- most commonly used medications in the pain alGative care settings, and because OIC is one ients with chronic experience OIC to gree. In fact, OIC ed in up to 90% its with cancer I 80% of patients mic nonmalignant :cause chronic pain of the most common adverse side effects associated with chronic opioid therapy,' Rhiner said that most patients with chronic pain will experience OIC to some degree. In fact, OIC is reported in up to 90% of patients with cancer pain and 80% of patients with chronic nonmalignant pain. She noted that because chronic pain patients rarely develop a tolerance to OIC, most of them will re- quire some form of pharmacologic therapy for constipation (up to 94% of patients with advanced illness who take opioids need laxatives, the most commonly used therapy for OIC). Untreated or undertreated OIC can compromise pain manage- ment in patients with cancer. Rhiner said that surveys have shown that O1C can cause patients to switch to switch to a different opioid, reduce their opioid dose (either in conjunction with their health care provider, or on their own without telling their provider), or even stop taking opioids altogether. Patients with OIC also use more health coy resources (they have more hospital admissions and doctor visits, use more home health services, etc). Rhiner said that OK also has a negative impact on quality of life and functionality in patients with chronic noncancer pain, leading to missed work, reduced productiv- ity, and compromised mental and physical health. Rhiner concluded her portion of the session by briefly review- ing normal colorectal functional processes. She said that bowel function is "governed by the enteric brain, an organ comprised of billions of neurons," and that any disruption in the neurotransmit- ter and mechanisms that regulate bowel function (such as those produce by opioids) can lead to constipation and bowel dysfunc- tion. She said that OK results when opioids bind with periphery sensors in the gut and in the enteric system.This affects not only the colon, but other components of the boweVgastrointestinal system, producing a spectrum of opioid-induced bowel dysfunction. This can indude cramping, bloating, decreased appetite, nausea and other symptoms in addition to constipation. She said that many of these symptoms are often missed by patients and providers and not attributed to the patient's opioid therapy. Assessing patients for OIC and selecting an appropriate management option During his portion of the presentation, McCarberg discussed the assessment and management of OK. He said that "there we no good diagnostic criteria for OIC." Although many patients and cli- nicians focus on stool frequency when discussing O1C, McCarberg said that this might not provide a complete picture because "there is wide variabMty in stool frequency" from patient to patient. Thus, when assessing patients for O1C, clinicians should also focus on other factors, such as those outlined in the Rome III criteria for functional constipation. McCarberg reminded the audience that these are not necessarily for O1C, just for functional constipation. There are no OIC-specific criteria: When assessing patients for O1C, taking a history is important to find out the patient's normal boweVdefecation routine in order to establish a baseline. "You have to ask the right questions" about the patient's previous and current bowel pattern and activity level, their amount of daly fiber and fluid intake, and laxative use prior PAINWeek Administ Redza Ibrahim Advertising, Sponsorships, Satellite Events Darryl Fossa Art Oiled on and Graphic Design Steve Porada Corporate Relations Debra Weiner Course Development Holly Caster Editorial Services Michael Shaffer Exhibit Sales', Management Wanda Tarnoff Finance Keith Dempster Mock Relations Benjamin R. Metzger, MD Meckal Direction Jeffrey Tamoff Operations and Technology Charles Brown Program Management Patrick Kelly Web and Print Production Pain Management Jack Lapping vke President, Sales Steve Porcelli Director of Sales Cowie Payson Notional Accounts Manager Megan O'Connell Soles & Marketing Coordinator Todd Kunkler Editor Silas Inman Web Editor Stephanie Ogozaly Assistant Web Ecitor John Salesi Art Director John Burke Group Director. Ciro,'otion & Production MJH & Associates Mike Hennessy Choir man /Chief Executive Officer/President Tighe Blazier Chief Operating Officer Neil Glasser, CPA/CFE EFTA01114706 I itoring gives you the IGHTof Rx Guardian CDs" you to compare your patient to a database nts clinically assessed for adherence. 2 5 The Rx Guardian (normalized drug with other clinica indicate that if yo pain patient falls: • Within -2.0 to higher likeliho • Outside -2.0 to a possibility of Your patient's sta are tracked over t identify patterns. ivardianC,D" with the new Rx Guardian INSIGHT Rel )vative tool to help assess adherence in your chronic pain patients. RECEDENTED SCIENCE 'X GUARDIAN CD'" • REVOLUTIONARY REPORTING WITH RX GUARDIAN INSIGHT REPORT lizes a proprietary, dynamic database of )re than one thousand chronic pain patients lically assessed for adherence advanced proprietary algorithm creates formalized value based on your patient's ysiological variables ur patient's normalized results are compared this proprietary database to help you assess ur patient's adherence ■ Standard scores are tracked over time to help: —Detect patterns of results that could indicate misuse, abuse, or diversion —Identify possible drug metabolism is! Identify illicit drug use Identify the absence of medications prescribed by you, as well as the presenc of medications you did not prescribe cally advanced urine drug monitoring system is brought to you by Ameritox, the leade ledication Monitoring". Together with your expertise, Rx Guardian CDS with the Rx GI Report can help you make clinical decisions to enhance the care of your chronic pain Booth #114, to learn more about Rx Guardii EFTA01114707 Kiln-fighting diet that calls for eliminating trans fats, artificial sweeteners, nutritionally deficient foods, digestive tract disruptors, and oth dients, patients may be able to effectively reduce the severity of their pain without the use of prescription medications. and Pain: Simple Rules for lealth" (CAM-Ol) S. Blatman, MD, DAAPM, ABIHM y, September 8 )0am '13, Castellano 1 e owes much of its success to a quality that's I among foodstuffs: an utter inability to sup- )st forms of life. ) eat it. Mold takes no root inside it. Even e it a miss. Industrial food makers, who have a mirade ingredient that can cut costs and )ave made it one of the most common ingre- humans ,ond all pds" that says Hal DAAPM, argarine yedients make us will ex- hINWeek wesenta- nd Pain: 'ain-Free actively Others I stop our what they are designed to do: heal them- prevent medications from working properly: ) runs the Blatman Pain Clinic in Cincinnati. rods and your patients will hurt less. They'll er to opioid medications —and develop less :an prescribe lower doses and stop worrying sing down your door." :nt the past couple of decades testing ingre- fighting diet he will outline during his talk. He very credible book and study he can find on le conducts tiny experiments, first on himself, I friends, and finally on patients. of testing have left him with a reasonably elines that seem to provide at least some every patient who sticks to them for any tman says that he cannot scientifically prove mess because he recommends it to every in maintaining control groups, but he be-hypothesize from what I've read about the mechanisms by which particular compounds increase pain. But case after case demonstrates a major impact. It's common for my patients with fibromyalgia to report that pain goes down by as much as half when they eliminate all artificial sweeteners," Blatman says. The insufficiently nutritious category includes many of the usual suspects: sugar, potatoes, fruit juices, and many other foods with high glycemic indexes. As for the digestive tract disruptors, the list there includes excessive red meat and all wheat products. "The gut plays an incredibly important role in good health," Blatman says. "The good flora that are inside of it break down your food so you can absorb nutrients properly. They also keep your immune sys- tem working right which is why patients with autoimmune dis- eases get particular relief when they start eating a gut-healthy diet." Blatman's dietary recommendations are simple. Sticking to them, however, can be tricky. Many diets advise patients to cut back on certain foods and ingredients. Blatman tells patients to avoid them completely, a maxim that requires not only iron self- discipline but also frequent detective work. Many of the forbid- den ingredients are found in a wide variety of foods, and often turn up in unexpected places. Blatman remembers one patient who "gave up" wheat but saw no health benefits--because she had no idea about the wheat in her favorite soy sauce. Patients must also be willing to wait long p start to see any benefits. Blatman cautions foods take weeks to work their way entirely Others take as long as four months, and a bite of the wrong thing can set the clock bac can see significant benefits just by cutting be ingredients I advise against, but in most case only come from total abstinence: Blatman sr Many patients, obviously, will sabotage th. ing here and there. Many end up simply at altogether. "Patients obviously have the right to cho but I make it clear to them that they are doir ing to be in pain. I also make it clear to the changes come before any unusually large Blatman says. "If they follow the diet religiously and the try what I can to fix that. But if the pain isn't e a patient to eat better, then it certainly isn't k to risk his or her health by increasing the op and again," Blatman says. "This diet isn't an e anything, but it produces very impressive res and it can do the same for yours." "Eliminate problem foods and ingredients and youi patients will hurt less. They'll also respond better tc medications —and develop less tolerance —so you cal prescribe lower doses and stop worrying about the kicking down your door." EFTA01114708 fective 24-hour pain control' nce-daily oral dosing with e evening meal' )w incidence of dizziness id somnolence' :ration to an 1800 mg dose 2 weeks' was a reported incidence of dizziness ) vs 2.2% placebo) and somnolence vs 2.7% placebo) at 1800 mg once daily? nore information, 3e visit Booth 316. ition and Usage ISE' is indicated for the management of Drpetic neuralgia (PHN). GRALISE is not )angeable with other gabapentin products Ise of differing pharmacokinetic profiles fect the frequency of administration. -tant Safety Information ISE is contraindicated in patients who have nstrated hypersensitivity to the drug or its ingredients. ileptic drugs (AEDs) including gabapentin, the active ingredient in GRALISE, increase suicidal thoughts or behavior in patients taking these drugs for any indication. Patient: with any AED for any indication should be monitored for the emergence or worsenir )ression, suicidal thoughts or behavior, and/or any unusual changes in mood or beha% lost common adverse reaction to GRALISE (5% and twice placebo) is dizziness. 3 all GRALISE clinical trials the other most common adverse reactions (2%) are Dlence, headache, peripheral edema, diarrhea, dry mouth, and nasopharyngitis. 'pes and incidence of adverse events were similar across age groups except for leral edema, which tended to increase in incidence with age. ;ee next page for Brief Summary of Prescribing Information, V. 14311-Hil+)+0 - • , Watch how GRALI: rrin technology works z Scan the barcode to view the video at /0-1 • EFTA01114709 antuntunata tiacnue natas t tat um %ea...maw at um picounisci n. Dose should be adjusted in patents with reduced renal function. GRALISE should not be h Gra less than 30 or in patents on hernodialysis. emetic neuralgia. GRALISE therapy should be initiated and nitrated as follows: ommended Titration Schedule Day 2 Days 3-6 Days 7-10 Days 11-14 Day 15 600 mg 900 mg 1200 mg 1500 mg 1800 mg S ated in patients with demonstrated hypersensitivity to the drug or its ingredients. age Based on Renal Function Once-daily dosing GRALISE dose (once daly with evening meal) 1800 mg 600 mg to 1800 mg GRALISE should not be administered 3digysis GRALISE should not be administered CAUTIONS engeable with other gabapentin products because of differing pharmacokinetic profiles that administration. The safety and effectiveness of GRALISE in patients with epilepsy has not been (prior and Ideation Antiepileptic drugs (AEDs). including gabapentn. the active Ogredient in risk of sticidal thoughts or behavior in patients taking these drugs for any indication. Patients ir any ideation should be monitored for the emergence or worsening of depression, suicidal nd/or any unusual changes in mood or behavior. ation for Antiepileptic Drugs (including gabapentin, the active ingredient Jed Analysis vents per 1000 patients its per 1000 patients of events in 3in placebo patients nal drug patients atients Epilepsy Psychiatric Other Total 1.0 5.7 1.0 2.4 3.4 8.5 1.8 4.3 3.5 1.5 1.9 1.8 2.4 2.9 0.9 1.9 *dal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials =dittos, but the absolute risk dif ferences were similar for the epilepsy and psychiatric isiderng prescribing GRALISE must balance the risk of suicidal thoughts or behavior with less. Epilepsy and many other illnesses for wtich products containng active components gabapenfin. the active component n GRALISE) are prescribed are themselves associated tarry and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and I treatment. the prescriber needs to consider whether the emergence of these symptoms y be related to the illness being treated. Patients, their caregivers. and families should be contains gabapentin %Mich is also used to treat epilepsy and that AEDs increase the risk of ehavior and should be advised of the need to be alert for the emergence or worsening of the depression. any unusual changes in mood or behavior, or the emergence of suicidal thoughts. bout self-harm. Behaviors of concern should be reported immediately( to healthcare providers. actin Gabapentin should be withdrawn gradualy. If GRALISE is discontinued. this should a minimum of 1 week or longer (at the discretion of the prescriber). Tumorigenic Potential vivo lif etime carcinogenicity studies, an unexpectedly high incidence of pancreatic acinar identified in male. but not female. rats. The cinical significance of this finding is triknoym. pentin therapy in epilepsy comprising 2,085 patient-years of exposure in patients over imam were reported in 10 patients, and preexisting tumors worsened in 11 patients, during fiscontinung the drug. However, no similar patient population untreated with gabapentin was :kground tumor incidence and recurrence nformaton for comparison. Therefore. the effect in the incidence of new tumors in humans or on the worsenng or recurrence of previously Morn. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)! °silkily Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known nsitivity. has been reported in patients taking antiepileptic drugs, including GRALISE. Some een fatal or life-threatening. DRESS typically, although not exclusively. presents with fever, !nopathy in association with other organ system involvement. such as hepatitis. nephritis, elites. myocardits, or myositis. sometimes resembling an acute viral infection. Eosinophilia ise this disorder is variable in its expression, other organ systems not noted here may be t to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, lough rash is not evident. If such signs or symptoms are present, the patient should be . GRALISE should be discontinued it an alternative etiology for the signs or symptoms Laboratory Tests Clinical trial data do not indicate that routine monitoring of clinical s necessary fa the sate use of GRALISE. The value of monitoring gabapentin blood been established. S ence Because clinical trials are conducted under widely varying conditions, adverse reaction itical trials of a drug cannot be directly compared to rates in the cinical trials of another :t the rates observed in practice. A total of 359 patients with neuropathic pain associated ilgia have received GRALISE at doses up to 1800 mg daily during placebo-controlled cfrical . in patients with postherpetic neuralgia, 9.7% of the 359 patients treated with GRALISE its treated with placebo discontinued prematurely due to adverse reactians. In the GRALISE ost common reason for discontinuation due to adverse reactions was dizziness. Of GRALISE- :perienced adverse reactions in clinical studies, the majority of those adverse reactions were ate'. Table 4 lists all adverse reactions, regardless of causally, occurring n at least 1% of It pain associated with postherpetic netralgia in the GRALISE group for which the incidence placet:0 group nergent Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain therpetic Neuralgia (Events in at Least 1% of all GRALISE-Treated Patients and in the Placehn Gronnl Dizziness 10.9 2.2 Somnolence 4.5 2.7 Headache 4.2 4.1 Lethargy 1.1 0.3 In addition to the adverse reactions reported in Table 4 above, the followng adverse reactionswith relationship to GRALISE were reported during the clinical development for the treatment of posthr Events in we than 1% of patients but equally or more frequently in the GRALISE-treated patient the placebo group included blood pressure increase, confusional state, gastroenteritis viral. herp hypertension, joint swelling, memory impairment. nausea, pneumonia, pyrexia, rash, seasonal all respiratory infection. Postmarlceting and Other Experience with other Formulations of Ga addition to the adverse experiences reported during clinical testing of gabapentin, the following ad have been reported n patients receiving other formulator's of marketed gabapentin. These adverse not been fisted above and data are insufficient to support an estimate of their incidence or to establ fistng is alphabetized: angioedema, blood glucose fluctuation, breast hypertrophy, erythema multi( liver function tests, fever. hyponatrernia. jaundice. movement disorder, Stevens-Jdrison syndrome. followng the abrupt discontinuation of gabapentin immediate release have also been reported. The reported events were anxiety, insomnia, nausea, pain and sweating. DRUG INTERACTIONS An increase in gabapentin AUC values has been reported when admiristmed with hydrocodone with morphine. An antacid containing aluminum hydroxide and magnesium hydroxide reduced lt of gabapentin immediate release by about approximately 20%, but by only 5% when gabapentir 2 hours after antacids. It is recommended that GRALISE be taken at least 2 hours following antaci There are no pharmacokinetic interactions between gabapentin and the folowing antiepileptic drui carbamazepine. valproic add, phenobarbital. and naproxen. Cimefidne decreased the apparent or gabapentin by 14% and creatinine clearance by 10%. The effect of gabapentin immediate release was not evaluated. This decrease is not expected to be clinically significant. Gabapentb immediate three times daily ) had no effect on the pharmacokinetics of nmethindrone (2.5 mg) or ethiwl esti administered as a single tablet, except that the Cin, of norethindrone was increased by 13%. This considered to be clinically significant. Gabapentil immediate release pharmacokinetic parameters with and without probenecid, indicating that gabapentin does not undergo renal tubular secretion t that is blocked by probenecid. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C: Gabapentin has been shown to be fetotoxic in rodents, causi ossification of several bales in the skull, vertebrae, forelimbs. and hindlimbs. There are no adequati controlled studies in pregnant women. This drug should be used dung pregnancy only if the potent justifies the potential risk to the fetus. To provide information regarding the effects of in Om expos' physicians are advised to recommend that pregnant patients taking GRALISE ergot in the North i Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-I and must be done by patients themselves. Information on the registry can also be found at the webs aedpregnancyregistry.org/. Nursing Mothers Gabapentin is secreted into human milk folowiig A nursed infant could be exposed to a maximum dose of approximately 1 mg/kg/day of gabapentin. effect an the nursing infant is unknown. GRALISE should be used in women who are nursing only it clearly outweigh the risks. Pediatric Use The safety and effectiveness of GRALISE in the manag postherpetic neuralgia in patients less than 18 years of age has not been studied. Geriatric Use of patients treated with GRALISE n controlled clinical trials n patients with postherpetic neuralgia which 63% were 65 years of age or older. The types and incidence of adverse events were simile groups except for peripheral edema, which tended to increase in incidence with age. GRALISE is substantially excreted by the kidney. Reductions in GRALISE dose should be made in patients wit compromised renal function. (see Dosage and Administration]. Hepatic Impairment Because g metabolized, studies have not been conducted in patients with hepatic impairment. Renal Impai is known to be substantially excreted by the kidney. Dosage adjustment is necessary in patients will function. GRALISE should not be administered in patients with CrCL between 15 and 30 or in patier hemodmtysis [see Dosage and Admitistrafion]. DRUG ABUSE AND DEPENDENCE The abuse and dependence potential of GRALISE has not been evaluated n human studies. OVERDOSAGE A lethal dose of gabapentin was not identified in mice and rats receivng single oral doses as high as • Signs of acute toxicity in animals included ataxia. labored breathing. Mosis, sedation, hypoactivity, c Acute oral overdoses of gabapentin immediate release in humans up to 49 grams have been reports cases, double vision, slurred speech, drowsiness, lethargy and diarrhea were observed. Al patients supportive care. Gabapentin can be removed by hemocfmtysis. Although hemodialysis has not been the few overdose cases reported, it may be ndicated by the patient's cinical state or in patients wit renal inpairment. CLINICAL PHARMACOLOGY Pharmacokinetics AbsomPtion and Sioavalability Gabapentin is absorbed from the proximal small saturable L-amino transport system. Gabapentin bioavaiabifity is not dose proportional: as the dose bioavailability decreases. When GRALISE (1800 mg once daily) and gabapentin immediate release times a day) were administered with high fat meals (50% of calories from fat), GRALISE has a bight AUC at steady state compared to gabapentii immediate release. Toe to reach maximum plasma a for GRALISE is 8 hcsirs.whth is about 4.6 hours longer compared to gabapentin immediate Meas. NONCLINICAL TOXICOLOGY Ca rcinogenesis, Mutagenesis, Impairment of Fertility Gabapentin was given in the diet to rr 600. and 2000 mg/kg/day and to rats at 250.1000. and 2000 mg/kg/day for 2 years. A statistic increase in the incidence of pancreatic acinar cell adenoma and carcinomas was found in male rat high dose; the no-effect dose for the occurrence of carcinomas was 1000 mg/kg/day. Peak plasm of gabapentn in rats receiving the high dose of 2000 mg/kg/day were more than 10 times higher concentrations in humans receiving 1800 mg per day and in rats receiving 1000 mg/kg/day peal concentrations were more than 6.5 times higher than n humans receiving 1800 mg/day. The pant carcinomas did not affect survival, did not metastasize and were not locally invasive. The relevana to carcinogenic risk in humans is unclear. Studies designed to investigate the mechanism of gabag pancreatic carcinogenesis in rats indicate that gabapentin stimulates DNA synthesis n rat pancrea in vitro and, thus. may be acting as a tumor promoter by enhancing mitogenic activity. It is not knot gabapentin has the ability to increase cell proliferation in other cell types or in other species, ncbc Gabapentn did not demonstrate mutagenic or genotoxic potential in 3 in vitro and 4 in vivo assays. hunch/ rr .nn,, cenn wan nhenniarl in rate al .here urn In ,nnn ennArn lennmvirnehal EFTA01114710 'the uassitications and treatments sis and treatment requires an understanding of the signs, symptoms, and clinical presentation of the multiple forms of tension-type headache rand Tension-Type Differential Diagnosis and ant" (MAS-06) y W. Jay, MD, FAAPM, DAAPM y, September 8 10pm ≥l 4, Nolita 3 ;sfully address ' needs and to lining treatment- idverse outcomes, Is need to be able nine the type of e their patient is Tee way headache specialists think about the relationship between tension-type and migraine headaches has shift- d considerably over the last several decades. At one point, not that far back, people thought of headaches as a spectrum; a straight line with tension-type headaches (BHA) at one end and migraines at the other end. Everything in be- tween were gradations," says Gary W. Jay, MD, FAAPM. He says that the question nowadays is whether they are essentially one headache with two different clinical pictures. To bring attendees of PAINWeek 2012 up to speed on the latest trends in headache medicine, Jay will present a two-hour master class, "Migraine and Tension-Type Headache: NOT Two Ends of a Spectrum!: on Saturday afternoon. During this com- prehensive session, he will review the pathophysiologies and varieties of migraine headaches and TTHAs, as well appropri- ate treatment options. According to Jay, a major challenge faced by health care providers who treat patients with headache is recognizing the multiple forms of TTHAs and migraines. "I will review what we know about what happens in the brain, particularly different forms of migraine headaches: says Jay. When many people think about migraines, they still think of the classical migraine headache—typically, a woman with a one-sided throbbing headache who has pain that is triggered by sound or light. Jay says that there are "multiple types of mi- graine and they can occur with or without aura." He also notes that the nature of aura varies widely, Aura is visual in 80 to 85 percent of patients; patients can have neurological aura that may elicit speech difficulty or even hemiplegia." To successfully address patients' needs and to avoid induc- ing treatment-related adverse outcomes, physicians need to be able to determine the type of headache their patient is experi- encing. As an example, triptans and ergot alkaloids are typical abortive treatments for migraines. "Both of these are vasocon- strictors and you never want to offer them to a patient that may have significant aura secondary to vasoconstriction," says Jay. "This can cause further vasoconstriction and neurological deficit and very possibly lead to long-term or permanent damage. It can induce infarction: The ability to differentiate between symptoms and possible causes can have a profound impact on outcomes and quality of life. if a patient calls you in the middle of night and tells you something is happening, you need to be able to make a decision on whether to meet them at the emergency room as soon as possible: Jay says. In some visual auras, patients may develop transient monocular vision loss. This presents simi- larly to amaurosis fugax, a transient ischemic attack involving a retinal artery. During his session, Jay will discuss strategies for confidently and accurately assessing these types of episodes and others. Earlier this year, the American Academy of Neurology and the American Headache Society jointly published updated evidence-based guidelines on preventive pharmacologic treat- ment for episodic migraine headaches. The guideline authors used stringent evaluation criteria to review existing evidence. ops," he says. "So what starts as possibly becomes centralized." In addition to reviewing TTHA pathophys ments, Jay will talk about diagnostic criteria mon TTHAs. Certain types of headaches a reproducible patterns of pericranial muscle tc ger point activation. "Pericranial muscle ten multiple etiologies, but arises most commont myofascial pain syndrome: says Jay. Myofa along the masseter muscle refer pain to the Trigger points may also elicit autonomic dysf, in the sternodeidomastoid muscle where tri<. sociated with lacrimation and redness, in ad "An example of what often happens i≤ comes in with temporomandibular joint (TMJ multiple surgeries for it, and the real problen the TMJ is being referred by a muscle: says In cases like this, "It is the job of the physi what the patient needs: Physicians need to origin of the pain. Jay hopes to convey the m the right questions is an important part of tre headaches. "Patients don't know what to tell them what you need to know: he says. Gary W. Jay is a neurological consultai in pain and disorders of the central nery president-elect of the Eastern Pain Associati. tion of the American Pain Society. He is a f the American Academy of Pain Manageme Academy of Pain Medicine. He was one of I the American Academy of Pain Medicine in EFTA01114711 pain assessment means going beyond matching a patient's pain to a number on a scale; it requires dinicians to consider ors and approaches. anent in Acute Care" (NRS-01) Ira Drew, MS, ACNS-BC, RN-BC y, September 8 OOam ≥l 3, Gracia 7 ,ent is gaining traction as an important faun- :ment of pain management. In August 2012, ommission issued a Sentinel Event Alert re- m of opioids in the hospital setting. This pub- he need to assess and monitor pain as part management program. specialists on this topic, Debra Drew, MS, will present "Pain Assessment in Acute Care" ek 2012. The presentation will provide an ossessment, including tools and approaches cial populations relevant to acute care set- eed to understand the complexities of the KI all its facets before they can design a plan omfortable," says Drew. nize the importance of viewing pain assess- that involves much more than administering iestionnaire to assign a score to the patient's ion of good pain management begins with assessment," says Drew. "Is the 0-10 pain in- J think of when you think of pain assessment? lot is 'yes,' you may be missing the boat: entation, Drew will review the latest findings pain assessment and discuss some of the ted with pain assessment in special popula- children and the elderly), as well as patients >us, ventilated, or developmentally delayed. )atients who can't verbalize their pain, who Is what they are feeling or can't speak," says cuss how to optimally assess pain when you lenging population: pain of patients in the intensive care unit ologic measures like blood pressure or pulse are often used to measure patient pain—represents one exam- ple of a challenging pain assessment scenario. Because blood pressure and pulse are not reliable pain indicators, providers are often left feeling helpless when trying to manage pain in this setting. "There are some observational tools that can be introduced in the ICU that provide a better way to assess whether or not a patient has pain, rather than relying on unreli- able variables," she says. "Pain assessment and management become complex when a patient cannot tell you what they are feeling. The fad that pain is a totally subjective and complex experience amplifies the difficulties: For some challenging populations, nurses and physicians may believe that pain assessment is not possible. But, Drew asserts that there is no such thing as a patient who cannot be assessed. "I would like to debunk that notion: she says. "There ting. During her presentation, Drew will provi for using the DIRE s