Presentation on theme: "Addressing the Barriers to Effective Pain Management and Issues of Opioid Misuse and Abuse Ross D. Lynch, MD Sponsored by The France Foundation Supported."— Presentation transcript:
1 Addressing the Barriers to Effective Pain Management and Issues of Opioid Misuse and Abuse Ross D. Lynch, MDSponsored by The France Foundation Supported by an educational grant from King Pharmaceuticals
2 Faculty DisclosureIt is the policy of The France Foundation to ensure balance, independence, objectivity, and scientific rigor in all its sponsored educational activities. All faculty, activity planners, content reviewers, and staff participating in this activity will disclose to the participants any significant financial interest or other relationship with manufacturer(s) of any commercial product(s)/device(s) and/or provider(s) of commercial services included in this educational activity. The intent of this disclosure is not to prevent a person with a relevant financial or other relationship from participating in the activity, but rather to provide participants with information on which they can base their own judgments. The France Foundation has identified and resolved any and all conflicts of interest prior to the release of this activity.The following faculty have indicated they have relationships with industry to disclose relative to the content of this CME activity:Dr. Ross D. Lynch has nothing to disclose.
3 Educational Learning Objectives Identify the negative impact of persistent pain on health and quality of life, methods to assess pain levels, appropriate use of opioid medications, and documentation required for compliance with regulatory policiesIntegrate appropriate risk assessment strategies for patient abuse, misuse, and diversion of opioids into an overall management approach for acute and chronic painDescribe the specific elements of new abuse deterrent technologies associated with opioid therapy, and assess their implications for clinical practice
4 Prevalence of Recurrent and Persistent Pain in the US 1 in 4 Americans suffer from recurrent pain (day-long bout of pain/month)1 in 10 Americans report having persistent pain of at least one year’s duration1 in 5 individuals over the age of 65 report pain persisting for more than 24 hours in the preceding month– 6 in 10 report pain persisting > 1 year2 out of 3 US armed forces veterans report having persistent pain attributable to military service– 1 in 10 take prescription medicine to manage painAmerican Pain Foundation. Accessed March 2010.
5 Multiple Types of Pain A. Nociceptive B. Inflammatory Neuropathic Pathophysiology of PainMultiple Types of PainExamplesStrains and sprainsBone fracturesPostoperativeOsteoarthritisRheumatoid arthritisTendonitisDiabetic peripheral neuropathyPost-herpetic neuralgiaHIV-related polyneuropathyFibromyalgiaIrritable bowel syndromeA. NociceptiveB. InflammatoryNeuropathicNoninflammatory/NonneuropathicNoxiousPeripheralStimuliInflammationMultiple MechanismsPeripheral Nerve DamageNo Known Tissue or Nerve DamageAbnormal Central ProcessingPatients may experience multiple pain states simultaneously1Adapted from Woolf CJ. Ann Intern Med. 2004;140:1. Chong MS, Bajwa ZH. J Pain Symptom Manage. 2003;25:S4-S11.5
6 Structural Remodeling Long-Term Consequences of Acute Pain: Potential for Progression to Chronic PainCNSNeuroplasticityHyperactivityStructural RemodelingSustainedActivationPeripheralNociceptiveFibersSensitizationSurgery or injury causes inflammationPeripheralNociceptiveFibersTransient ActivationSustainedcurrentsCHRONICPAINACUTEPAINWoolf CJ, et al. Ann Intern Med. 2004;140: ; Petersen-Felix S, et al. Swiss Med Weekly. 2002;132: ; Woolf CJ. Nature.1983;306: ; Woolf CJ, et al. Nature. 1992;355:75-78.6Petersen-Felix S, Curatolo M. Neuroplasticity--an important factor in acute and chronic pain. Swiss Med Wkly. 2002;132(21-22):Woolf CJ. Pain: moving from symptom control toward mechanism-specific pharmacologic management. Ann Intern Med. 2004;140(6):
7 Vicious Cycle of Uncontrolled Pain AvoidanceBehaviorsDecreasedMobilityPainSocialLimitationsAlteredFunctionalStatusDiminishedSelf-Efficacy7
8 Breaking the Chain of Pain Transmission UPDATEDGottschalk, 2001P1981Iyengar, 2004P583Morgan, 2005Reimann, 1999 P141Vanegas 2001P327Malmberg 1992P163Stein 1989 P1269Gottschalk, 2001P19835-HT = serotonin; NE = norepinephrine; TCA = tricyclic antidepressant1. Gottschalk A, Smith DS. Am Fam Physician. 2001;63: ; 2. Iyengar S, et al. J Pharmacol Exp Ther. 2004;311: ; 3. Morgan V, et al. Gut. 2005;54: ; 4. Reimann W, et al. Anesth Analg. 1999;88: Vanegas H, Schaible HG. Prog Neurobiol. 2001;64: ; 6. Malmberg AB, Yaksh TL. J Pharmacol Exp Ther. 1992;263: ; 7. Stein C, et al. J Pharmacol Exp Ther. 1989;248:Gottschalk and Smith. New concepts in acute pain therapy: preemptive analgesia. Am Fam Physician. 2001;63:
9 Multimodal Treatment Strategies for Pain and Associated Disability Lifestyle ChangeExercise, weight lossStrategies for Pain and Associated DisabilityPharmacotherapyOpioids, nonopioids, adjuvant analgesicsInterventional ApproachesInjections, neurostimulationPhysical Medicine and RehabilitationAssistive devices, electrotherapyPsychological SupportPsychotherapy, group supportComplementary and Alternative MedicineMassage, supplementsFine PG, et al. J Support Oncol. 2004;2(suppl 4): Portenoy RK, et al. In: Lowinson JH, et al, eds. Substance Abuse: A Comprehensive Textbook. 4th ed. Philadelphia, PA: Lippincott, Williams & Wilkins; 2005:
10 Positioning Opioid Therapy for Chronic Pain Chronic non-cancer pain: evolving perspectiveConsider for all patients with severe chronic pain, but weigh the influencesWhat is conventional practice?Are there reasonable alternatives?What is the risk of adverse events?Is the patient likely to be a responsible drug-taker?Fine PG, Portenoy RK. Clinical Guide to Opioid Analgesia, 2nd edition, 2007.Jovey RD, et al. Pain Res Manag. 2003;8(Suppl A):3A-28A.Eisenberg E, et al. JAMA. 2005;293:Gilron I, et al. N Engl J Med. 2005;352:10
11 Chronic Opioid Therapy Guidelines and Treatment Principles Patient SelectionPatient Selection and Risk Stratification ( )Initial Patient AssessmentInformed Consent and Opioid Management Plans ( )High-Risk Patients ( )Alternatives to Opioid TherapyUse of Psycho-therapeutic Cointerventions (9.1)Comprehensive Pain Management PlanDriving and Work Safety (10.1)Identifying a Medical Home* and When to Obtain Consultation ( )Chou R, et al. J Pain. 2009;10: *Clinician accepting primary responsibility for a patient’s overall medical care.
12 Chronic Opioid Therapy Guidelines and Treatment Principles (cont) Trial of Opioid TherapyInitiation and Titration of Chronic Opioid Therapy ( )Methadone (4.1)Opioids and Pregnancy (13.1)Patient ReassessmentMonitoring ( )Dose Escalations, High-Dose Opioid Therapy, Opioid Rotation, Indications for Discontinuation of Therapy ( )Opioid Policies (14.1)Continue Opioid TherapyMonitoring ( )Breakthrough Pain (12.1)Implement Exit StrategyOpioid-Related Adverse Effects (8.1)Chou R, et al. J Pain. 2009;10: *Clinician accepting primary responsibility for a patient’s overall medical care.
13 Opioid Formulations Type of Drug Examples Pure m-opioid receptor agonistsMorphine, hydromorphone, fentanyl, oxycodoneDual mechanism opioidsTramadol, tapentadolRapid onset (transmucosal)Fentanyl, alfentanil, sufentanil, diamorphineImmediate releaseTramadol, oxycodoneModified release (long acting)Morphine, methadone, oxycodoneAvailable with co-analgesicOxycodone, tramadol, codeineOnly available with co-analgesicHydrocodone
14 Formulation Points to Consider Dose-limiting issues and toxicity with co-analgesics4 g/day acetaminophen limitImportance of titrationRisk of overdose, challenges of dose conversion during rotationPharmacokinetics versus temporal patterns of painAdherenceCostConvenienceCaregiving issues
15 Domains for Pain Management Outcome: The 4 A’s AnalgesiaActivities of Daily LivingAdverse EventsAberrant Drug-Taking BehaviorsPassik SD, Weinreb HJ. Adv Ther. 2000;17:70-83.Passik SD, et al. Clin Ther. 2004;26:
16 Federation of State Medical Boards of the United States, Inc Model Policy for the Use of Controlled Substances for the Treatment of PainFederation of State Medical Boards House of Delegates, May Accessed March 2010.16
17 FSMB Model Policy Basic Tenets Pain management is important and integral to the practice of medicineUse of opioids may be necessary for pain reliefUse of opioids for other than a legitimate medical purpose poses a threat to the individual and societyPhysicians have a responsibility to minimize the potential for abuse and diversionPhysicians may deviate from the recommended treatment steps based on good causeNot meant to constrain or dictate medical decision-makingFSMB, Federation of State Medical Boards17
18 New Illicit Drug Use United States, 2006 Pain Relievers*TranquilizersCocaineEcstasyLSD†MarijuanaInhalantsStimulantsSedativesHeroin69912642677838458609771,1122,0632,1505001,0001,5002,0002,500New Users (thousands)PCP†*533,000 new nonmedical users of oxycodone aged ≥ 12 years. Past year initiates for specific illicit drugs among people aged ≥ 12 years. †LSD, lysergic acid diethylamide; PCP, phencyclidine.Substance Abuse and Mental Health Services Administration, Office of Applied Studies National Survey on Drug Use and Health. Department of Health and Human Services Publication No. SMA ; 2007.18
19 Definition of Terms Misuse Abuse Diversion Addiction Pseudoaddiction Use of a medication (for a medical purpose) other than as directed or as indicated, whether willful or unintentional, and whether harm results or notKatz 2007 p650, C1, Table 1AbuseAny use of an illegal drugThe intentional self administration of a medication for a nonmedical purpose such as altering one’s state of consciousness, eg, getting highDiversionThe intentional removal of a medication from legitimate and dispensing channelsAddictionA primary, chronic, neurobiological disease, with genetic, psychosocial, and environmental factors influencing its development and manifestationsBehavioral characteristics include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, cravingPseudoaddictionSyndrome of abnormal behavior resulting from undertreatment of pain that is misidentified by the clinician as inappropriate drug-seeking behaviorBehavior ceases when adequate pain relief is providedNot a diagnosis; rather, a description of the clinical intentionKatz NP, et al. Clin J Pain. 2007;23:19
20 Prevalence of Misuse, Abuse, and Addiction Total Pain PopulationAddiction: 2% to 5%Webster LR, Webster RM. Pain Med. 2005;6(6):20
21 Who Misuses/Abuses Opioids and Why? NonmedicalUseRecreational abusersPatients with disease of addictionMedical UsePain patients seeking more pain reliefPain patients escaping emotional pain212121
22 Risk Factors for Aberrant Behaviors/Harm BiologicalPsychiatricSocialAge ≤ 45 yearsGenderFamily history of prescription drug or alcohol abuseCigarette smokingSubstance use disorderPreadolescent sexual abuse (in women)Major psychiatric disorder (eg, personality disorder, anxiety or depressive disorder, bipolar disorder)Prior legal problemsHistory of motor vehicle accidentsPoor family supportInvolvement in a problematic subcultureKatz NP, et al. Clin J Pain. 2007;23: ; Manchikanti L, et al. J Opioid Manag. 2007;3:Webster LR, Webster RM. Pain Med. 2005;6:22
23 10 Principles of Universal Precautions Diagnosis with appropriate differentialPsychological assessment including risk of addictive disordersInformed consent (verbal or written/signed)Treatment agreement (verbal or written/signed)Pre-/post-intervention assessment of pain level and functionAppropriate trial of opioid therapy adjunctive medicationReassessment of pain score and level of functionRegularly assess the “Four A’s” of pain medicine: Analgesia, Activity, Adverse Reactions, and Aberrant BehaviorPeriodically review pain and comorbidity diagnoses, including addictive disordersDocumentationUniversal precautions revisited: managing the inherited pain patient.Gourlay DL, Heit HA.Pain Med Jul;10 Suppl 2:SUniversal precautions in pain medicine: a rational approach to the treatment of chronic pain.Gourlay DL, Heit HA, Almahrezi A.Pain Med Mar-Apr;6(2):Gourlay DL, Heit HA. Pain Med. 2009;10 Suppl 2:SGourlay DL, et al. Pain Med. 2005;6(2):
25 Algorithm for the Management of Chronic Pain Pain frequencyFrequency flares of constant disturbing painInfrequent flares < 4 days per weekAnalgesicsPhysical therapyPsychologyAdditional featuresOccupational therapyIneffective or require excessive dosesFlare management: oscillatory movements, distraction techniques, trigger point massageRelaxation Stress managementShort-acting opioidsNeuropathic pain, burning quality, nerve injury, neuralgiaStructural pathology with disability and or overuse of analgesicsReconditioning Stretching exercisesBody mechanics Work simplification Pacing skillsCognitive restructuring Relaxation Stress managementFirst lineAdjunctiveLong-acting opioidsCapsaicin cream Mexiletine Long-acting opioidsAntidepressants: TCA, SSRI Antiepileptics: gabapentin, lamotrigineTCA = tricyclic antidepressants: SSRI = selective serotonin reuptake inhibitorsMarcus DA. Am Fam Physician. 2000;61(5):
26 Medical Records Maintain accurate, complete, and current records Medical Hx & PEDiagnostic, therapeutic, lab resultsEvaluations/consultationsTreatment objectivesDiscussion of risks/benefitsTx and medicationsInstructions/agreementsPeriodic reviewsDiscussions with and about patientsFishman SM. Pain Med. 2006;7: Federation of State Medical Boards of the United States, Inc. Model Policy for the Use of Controlled Substances for the Treatment of Pain26
27 ConsiderationsWhat is conventional practice for this type of pain or pain patient?Is there an alternative therapy that is likely to have an equivalent or better therapeutic index for pain control, functional restoration, and improvement in quality of life?Does the patient have medical problems that may increase the risk of opioid-related adverse effects?Is the patient likely to manage the opioid therapy responsibly?Who can I treat without help?Who would I be able to treat with the assistance of a specialist?Who should I not treat, but rather refer, if opioid therapy is a consideration?Fine PG, Portenoy RK. Clinical Guide to Opioid Analgesia. Vendome Group, New York, 2007.
28 Opioid Treatment Agreement Accessed March 2010.
30 Identifying Who Is at Risk for Opioid Abuse and Diversion Predictive toolsAberrant behaviorsUrine drug testingPrescription monitoringprogramsSeverity and duration of painPharmacist communicationFamily and friendsPatients30
31 Signs of Potential Abuse and Diversion Request appointment toward end-of-office hoursArrive without appointmentTelephone/arrive after office hours when staff are anxious to leaveReluctant to have thorough physical exam, diagnostic tests, or referralsFail to keep appointmentsUnwilling to provide past medical records or names of HCPsUnusual storiesHowever, emergencies happen: not every person in a hurry is an abuser/diverterDrug Enforcement Administration. Don't be Scammed by a Drug Abuser Cole BE. Fam Pract Manage. 2001;8:37-41.3131
32 Urine Drug Testing When to test? What type of testing? Randomly, annually, PRNWhat type of testing?POC, GS/MSHow to interpretMetabolism of opioidsFalse positive and negative resultsWhat to do about the resultsConsult, refer, change therapy, discharge
33 The Role of UDT UDT in clinical practice may Provide objective documentation of compliance with treatment plan by detecting presence of a particular drug or its metabolitesAssist in recognition of addiction or drug misuse if results abnormalResults are only as reliable as testing laboratory’s ability to detect substance in questionHeit HA, Gourlay DL. J Pain Symptom Manage. 2004;27: Dove B, Webster LR. Avoiding Opioid Abuse while Managing Pain: a Guide for Practitioners.North Branch, MN: Sunrise River Press; 2007.33
34 Positive and Negative Urine Toxicology Results Positive forensic testingLegally prescribed medicationsOver-the-counter medicationsIllicit drugs or unprescribed medicationsSubstances that produce the same metabolite as that of a prescribed or illegal substanceErrors in laboratory analysisNegative compliance testingMedication bingeingDiversionInsufficient test sensitivityFailure of laboratory to test for desired substancesHeit HA, Gourlay DL. J Pain Symptom Manage. 2004;27:34
35 Opioid Metabolism Heroin 6-MAM M-3G Morphine Codeine C-6G Hydrocodone Not comprehensive pathways, but may explain presence of apparently unprescribed drugsHeroin6-MAMM-3GMorphineCodeineC-6GHydrocodoneHydromorphoneMinorMinorDihydrocodeineDihydromorphoneGourlay D, et al. Accessed March 2010;Cone EJ, et al. J Anal Toxicol. 2006;30:1-5; Heit HA, Gourlay D. Personal Communication3535
36 Detection Times of Common Drugs of Misuse Approximate Retention TimeAmphetamines48 hoursBarbituratesShort-acting (eg, secobarbital), 24 hoursLong-acting (eg, phenobarbital), 2–3 weeksBenzodiazepines3 days if therapeutic dose is ingestedUp to 4–6 weeks after extended dosage (≥ 1 year)CannabinoidsModerate smoker (4 times/week), 5 daysHeavy smoker (daily), 10 daysRetention time for chronic smokers may be 20–28 daysCocaine2–4 days, metabolizedEthanol2–4 hoursMethadoneApproximately 30 daysOpiates2 daysPhencyclidineApproximately 8 daysUp to 30 days in chronic users (mean value = 14 days)Propoxyphene6–48 hoursGourlay DL, Heit HA. Pain Med. 2009;10 Suppl 2:S
37 Risk Evaluation and Mitigation Strategies Position of the FDAThe current strategies for intervening with [the problem of prescription opioid addiction, misuse, abuse, overdose and death] are inadequateNew authorities granted under FDAAA: [FDA] will now be implementing Risk Evaluation and Mitigation Strategies (REMS) for a number of opioid products[FDA expects] all companies marketing these products to [cooperate] to get this done expeditiouslyIf not, [FDA] cannot guarantee that these products will remain on the marketRappaport BA. REMS for Opioid Analgesics: How Did We Get Here? Where are We Going? FDA meeting of manufacturers of ER opioids, FDA White Oak Campus, Silver Spring, MD. March 3, 2009.
38 States with PMPs Operational PMP:32 Start-up phase: 6 In legislative process: 11No action: 1Office of Diversion Control. Accessed March 2010.
39 Case Study: Opioid Renewal Clinic What is the impact of a structured opioid renewal program? Primary goal: reduce oxycodone SA use to 3% of opioidsSettingPrimary careManaged by nurse practitioner and clinical pharmacistPhiladelphia VA pain clinicStructured programElectronic referral by PCPSigned Opioid Treatment AgreementUDTSupport from multidisciplinary pain team: addiction psychiatrist, rheumatologist, orthopedist, neurologist, and physiatristMultimodal managementOpioidsNSAIDs and acetaminophen for osteoarthritisTranscutaneous electrical stimulation (TENS) unitsAntidepressants and anticonvulsants for neuropathic painReconditioning exercisesPain Med Oct-Nov;8(7):The opioid renewal clinic: a primary care, managed approach to opioid therapy in chronic pain patients at risk for substance abuse.Wiedemer NL, Harden PS, Arndt IO, Gallagher RM.Philadelphia VA Medical Center, Philadelphia, Pennsylvania 19104, USA.Comment in:Pain Med Oct-Nov;8(7):544-5.OBJECTIVE: To measure the impact of a structured opioid renewal program for chronic pain run by a nurse practitioner (NP) and clinical pharmacist in a primary care setting. PATIENTS AND SETTING: Patients with chronic noncancer pain managed with opioid therapy in a primary care clinic staffed by 19 providers serving 50,000 patients at an urban academic Veterans hospital. DESIGN: Naturalistic prospective outcome study. INTERVENTION: Based on published opioid prescribing guidelines and focus groups with primary care providers (PCPs), a structured program, the Opioid Renewal Clinic (ORC), was designed to support PCPs managing patients with chronic noncancer pain requiring opioids. After training in the use of opioid treatment agreements (OTAs) and random urine drug testing (UDT), PCPs worked with a pharmacist-run prescription management clinic supported by an onsite pain NP who was backed by a multi-specialty Pain Team. After 2 years, the program was evaluated for its impact on PCP practice and satisfaction, patient adherence, and pharmacy cost. RESULTS: A total of 335 patients were referred to the ORC. Of the 171 (51%) with documented aberrant behaviors, 77 (45%) adhered to the OTA and resolved their aberrant behaviors, 65 (38%) self-discharged, 22 (13%) were referred for addiction treatment, and seven (4%) with consistently negative UDT were weaned from opioids. The 164 (49%) who were referred for complexity including history of substance abuse or need for opioid rotation or titration, with no documented aberrant drug-related behaviors, continued to adhere to the OTA. Use of UDT and OTAs by PCPs increased. Significant pharmacy cost savings were demonstrated. CONCLUSION: An NP/clinical pharmacist-run clinic, supported by a multi-specialty team, can successfully support a primary care practice in managing opioids in complex chronic pain patients.Wiedemer NL, et al. Pain Med. 2007;8(7):
40 Opioid Renewal Clinic: Results OTAs increased: 63 214Monthly UDTs increased: 80 200Oxycodone SA use decreasedQuarterly costs: $130,000 $5,000Percent of opioids: 22.5% 0.4%ER visits reduced 73%Unscheduled PCP visits reduced 60%PCPs satisfied (questionnaire)171/335 patients referred had aberrant drug-taking behaviors45% adhered to OTA (resolved aberrant behaviors)38% self-discharged from ORC13% referred for addiction treatment4% consistently negative UDTPain Med Oct-Nov;8(7):The opioid renewal clinic: a primary care, managed approach to opioid therapy in chronic pain patients at risk for substance abuse.Wiedemer NL, Harden PS, Arndt IO, Gallagher RM.Philadelphia VA Medical Center, Philadelphia, Pennsylvania 19104, USA.Comment in:Pain Med Oct-Nov;8(7):544-5.OBJECTIVE: To measure the impact of a structured opioid renewal program for chronic pain run by a nurse practitioner (NP) and clinical pharmacist in a primary care setting. PATIENTS AND SETTING: Patients with chronic noncancer pain managed with opioid therapy in a primary care clinic staffed by 19 providers serving 50,000 patients at an urban academic Veterans hospital. DESIGN: Naturalistic prospective outcome study. INTERVENTION: Based on published opioid prescribing guidelines and focus groups with primary care providers (PCPs), a structured program, the Opioid Renewal Clinic (ORC), was designed to support PCPs managing patients with chronic noncancer pain requiring opioids. After training in the use of opioid treatment agreements (OTAs) and random urine drug testing (UDT), PCPs worked with a pharmacist-run prescription management clinic supported by an onsite pain NP who was backed by a multi-specialty Pain Team. After 2 years, the program was evaluated for its impact on PCP practice and satisfaction, patient adherence, and pharmacy cost. RESULTS: A total of 335 patients were referred to the ORC. Of the 171 (51%) with documented aberrant behaviors, 77 (45%) adhered to the OTA and resolved their aberrant behaviors, 65 (38%) self-discharged, 22 (13%) were referred for addiction treatment, and seven (4%) with consistently negative UDT were weaned from opioids. The 164 (49%) who were referred for complexity including history of substance abuse or need for opioid rotation or titration, with no documented aberrant drug-related behaviors, continued to adhere to the OTA. Use of UDT and OTAs by PCPs increased. Significant pharmacy cost savings were demonstrated. CONCLUSION: An NP/clinical pharmacist-run clinic, supported by a multi-specialty team, can successfully support a primary care practice in managing opioids in complex chronic pain patients.Wiedemer NL, et al. Pain Med. 2007;8(7):
41 Opioid Abuse-Deterrent Increasing Direct Abuse Deterrence Strategies HierarchyCombination MechanismsPharmacologicSequestered antagonistBio-available antagonistPro-drugAversive ComponentCapsaicin – burning sensationIpecac – emeticDenatonium – bitter tasteIncreasing Direct Abuse DeterrencePhysicalDifficult to crushDifficult to extractDeterrent PackagingRFID – ProtectionTamper-proof bottlesPrescription Monitoring41
42 Electronic Track and Trace RFID Secures integrity of drug supply chain by providing accurate drug "pedigree"A record documenting that the drug was manufactured and distributed under secure conditions.RFID technologyTiny radio frequency chip containing essential data in the form of an electronic product code (EPC)Each discrete product unit has a unique electronic serial numberProduct can be tracked electronically through every step of the supply chainRFID, radiofrequency identification
43 Physical Deterrent: Viscous Gel Base SR oxycodone formulation: Remoxy™Deters dose dumpingAccessing entire 12-h dose of CR medication at 1 timeDifficult to crush, break, freeze, heat, dissolveThe viscous gel-cap base of PTI-821 cannot be injectedResists crushing and dissolution in alcohol or water43
45 Pharmacologic Deterrent: Antagonist Oral formulationSequestered antagonistAntagonist bioavailable only when agent is crushed for extractionSR morphine + naltrexone (Embeda®) FDA approved 2009Webster LR, Dove B. Avoiding Opioid Abuse While Managing Pain: A Guide for Practitioners. 1st ed. North Branch, MN: Sunrise River Press; 2007.45
46 Conclusion Use of opioids may be necessary for pain relief Balanced multimodal careUse of opioids as part of complete pain careAnticipation and management of side effectsJudicious use of short and long acting agentsFocus on persistent and breakthrough painMaintain standard of careH&P, F/U, PRN referral, functional outcomes, documentationTreatment goalsImproved level of independent functionIncrease in activities of daily livingDecreased pain4046
47 Conclusion (cont) Pharmacovigilance Open Issues Functional outcomes Standard medical practiceFSMB policyOpen IssuesWhat is meant by pain management?Who needs what treatment?Do universal approaches work?Does it improve outcomes?For patientsFor regulators4047
48 Online Resources Resource Web Address American Academy of Pain MedicineAmerican Pain SocietyFederation of StateMedical BoardsAmerican Academy of Pain ManagementPMQMcGill Pain Questionnaire (Melzack R. Pain.1987;30: )Opioid Management PlanOpioid Treatment AgreementMelzack R. The McGill Pain Questionnaire. In: Pain Measurement and Assessment. New York:Raven Press, 1983,Melzack, R. The short-form McGill Pain Questionnaire. Pain 1987;30:191-7.OTA: see Gourlay? Passik?