Session III. SAFE Opioid Prescribing Strategies. Assessment. Fundamentals. Education. Presenter Disclosure Information. Presenting Faculty

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1 Presenter Disclosure Information SAFE Opioid Prescribing Strategies. Assessment. Fundamentals. Education 2:30 3pm Evidence-Based Tools for Screening for Patients at Risk and Monitoring for Adherence to Prescribed ER/LA Opioids SPEAKERS Charles Argoff, MD Bill H. McCarberg, MD, FABM Steven P. Stanos, DO The following relationships exist related to this presentation: Dr Argoff receives advisor/consultant honoraria from Endo, Collegium Pharmaceutical, Depomed, Lilly, Ameritox, QRX Pharma, Pfizer, Daiichi-Sankyo, Teva Pharmaceutical expert investigator honoraria from Endo, Alllergan, Janssen, Miller Labs, Lilly and receives grants from Endo/Lilly and Forest Laboratories. Dr McCarberg receives advisor honorarium from Iroko, NeurogesX, Pfizer, Salix, Sucampo, Teva and Zogenix. Dr Stanos receives advisory board/consultant honorarium from Endo Pharmaceuticals, Pfizer, MyMatrixx and GlaxoSmith Kline. Off-Label/Investigational Discussion In accordance with pmicme policy, faculty have been asked to disclose discussion of unlabeled or unapproved use(s) of drugs or devices during the course of their presentations. Presenting Faculty SAFE Opioid Prescribing Strategies. Assessment. Fundamentals. Education Extended-Release and Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) SESSION III Steven P. Stanos, DO (Moderator) Medical Director Center for Pain Management Rehabilitation Institute of Chicago Assistant Professor Department of Physical Medicine and Rehabilitation Assistant Program Director Multidisciplinary Pain Fellowship Feinberg School of Medicine Northwestern University Chicago, Illinois Charles Argoff, MD Professor of Neurology Albany Medical College Director Comprehensive Pain Program Albany Medical Center Albany, New York Bill H. McCarberg, MD, FABM Founder Chronic Pain Program Kaiser Permanente San Diego, California 3 4 Learning Objectives for Session III Session III Upon completion of this module, the participants will be better able to: Evaluate and manage adverse effects of ER/LA opioids Differentiate strategies for monitoring patient adherence Evidence-Based Tools for Screening for Patients at Risk and Monitoring for Adherence to Prescribed ER/LA Opioids 5 6 1

2 Opioid Therapy in Chronic Pain Management Key Principles of Managing Therapy With ER/LA Opioids Opioids ARE commonly prescribed for chronic pain Efficacious for many types of pain Appropriate use is KEY to safety and success Goals of chronic opioid therapy: Improve and/or stabilize pain intensity Improve function Improve quality of life (QOL) However, significant gaps exist between guideline recommendations for safe prescribing practices of ER/LA opioids and how they are being used in practice Highlights need for further education Use clinical evidence-based guidelines to: Screen for risk, including assessment of psychiatric comorbidities Establish analgesic and functional goals Use Patient Prescriber Agreements (PPAs) and monitor patient adherence Anticipate/Manage adverse effects and periodically assess benefits and side effects Reevaluate patient s underlying medical condition if clinical presentation changes over time Use referral sources for the treatment of abuse and addiction McCarberg BH. Postgrad Med. 2011;123(2): FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. Accessed February 23, Realistic Individualized Goal-Setting Patient Prescriber Agreement (PPA) Reach agreement with patient on treatment goals Patient-specific goals may include 1 or more of the following Pain reduction: 30% considered clinically significant - Explain to patient that complete pain relief rarely achieved Improvement in select functional areas: - eg, ability to work full time at previous or modified job; play golf once a week, walk the dog daily Improved mood Clinical evidence and guidelines support use of agreements Any of following can be used as a PPA: Informed consent documents Treatment agreement documents PPA available for download at no cost* Benefits Informed decision making with patient Enables clear and mutual understanding of goals and expectations and respective responsibilities of patient and clinician Can be jointly signed during patient visit *eg, What Is Typically in a Patient Prescriber Agreement (PPA) Monitoring Patient Adherence Understanding of risks and benefits of opioid therapy Taking the opioid exactly as prescribed One prescribing doctor and one designated pharmacy and whether or not refills will be called into pharmacy without an office visit Urine/serum drug testing when requested Pill counts at each office visit No early refills Level of monitoring depends on risk stratification level determined during initial screening (using ORT or other tool) State PDMPs (Prescription Drug Monitoring Programs) Urine drug testing (UDT) Pill counts Behavioral assessment at each visit - If indicated, refer for substance abuse treatment How to safeguard their opioids medication List of behaviors that may lead to discontinuation of opioids Places for signature and dating

3 Monitoring Patient Adherence Prescription Drug Monitoring Programs (PDMPs) PDMPs: 2012 Operational or Legislated in 49 States, 1 Territory State-run electronic databases that track dispensing of controlled substances Can provide clinicians with critical information about patient prescription history and identify doctor shoppers Currently available in almost all states No national standards for guidance; implementation of programs is variable Real-time data access not yet available in all states Each state has its own rules and laws Follow state guidelines Dahl J. J Pain. April 2012;13:Abstract 245; Dahl J, et al. J Pain. April 2012;13:Abstract Alliance of States with Prescription Monitoring Programs. Operational Legislated but not operational Legislation pending 18 A Sample PDMP Report: West Virginia = Board Of Pharmacy Patient Profile Monitoring Patient Adherence: Urine Drug Testing (UDT) Date 4/15/2012 Date of Birth Beginning Date: =nbsp Ending Date: First : MIKE Last : =OWEN First Address Zip Fill date Rx no. Product MIKE 319 LOWER /2/ APAP/HYDRO MIKE 319 LOWER /3/ APAP/HYDRO MIKE 319 LOWER /27/ APAP/HYDRO Strength Qty Doctor Doctor DEA 180 SMITH JOE DH SMITH JOE DH SMITH JOE DH Pharm TOM S TOM S TOM S Pharm Ph Zip DEA GF GF GF Recommended for all patients for reasons of safety and to remove the stigma associated with UDTs Testing does not imply a lack of trust; it is a conversation starter Self reports of drug use and behavioral monitoring often fail to detect abuse problems UDTs can identify use of prescribed opioids as well as illicit drug use Know limitations of UDT or laboratory that you use MIKE 319 LOWER /4/ APAP/HYDRO 180 JOHN JOHN DH BILL S AF Katz NP, et al. Anesth Analg. 2003;97(4): ; Heit HA, et al. J Pain Symptom Manage. 2004;27(3): Urine Drug Testing KEY POINTS Common UDT Scenarios Know what to expect and how to interpret results Parent compound and or metabolite should show up in the urine Oxycodone oxymorphone Hydrocodone hydromorphone Codeine morphine Is the substance present that you expect? Are there substances present that you do not expect? Know what your laboratory does Peter undergoes UDT in office and the test is negative for opioids UDTs do differ Certain drugs, including oxycodone, may not be detected UDT is a conversation starter: Why do you think your UDT is negative? - Is diversion a possibility? - Is he bingeing and then running out of opioids? - Is he failing to take the prescribed drug because symptoms have abated? - Do you give him a 30-day Rx supply? Heit HA, et al. J Pain Symptom Manage. 2004;27(3):

4 Common UDT Scenarios Common UDT Scenarios Patient on LA morphine undergoes UDT. Test results positive for morphine and hydromorphone Possible explanations include: Patient using another opioid obtained from another physician Hydromorphone is a trace metabolite of morphine found only when very high morphine concentrations are present Patient being treated with hydrocodone has UDT positive for hydrocodone and hydromorphone After hydrocodone use, urine may be positive for: Hydrocodone only Hydrocodone and hydromorphone (metabolite) Hydromorphone only Common UDT Scenarios Screening vs Confirmatory UDTs Patient reports no relief on codeine and UDT is negative Possible explanations include Laboratory error Diversion Patient is a slow metabolizer of codeine SCREENING CONFIRMATORY ANALYSIS TECHNIQUE Immunoassay GC-MS or HPLC SENSITIVITY (POWER TO DETECT A CLASS OF DRUGS) SPECIFICITY (POWER TO DETECT AN INDIVIDUAL DRUG) Low or none when testing for semi-synthetic or synthetic opioids Varies (can result in false-positives or false-negatives) High High TURNAROUND Rapid Slow OTHER Intended for a drug-free population. May not be useful in pain medicine. Legally defensible results Heit HA, et al. J Pain Symptom Manage. 2004;27(3): GC-MS, gas chromatograph mass spectrometer; HPLC, high performance liquid chromatography Anticipating and Managing Adverse Effects Anticipating and Managing Adverse Effects Adverse Effect Treatment Adverse Effect Treatment Nausea and vomiting Sedation Anti-emetics; Switch opioids* Lower dose (if possible); Add nonsedating co-analgesic; Add stimulant or attention enhancer Itching Endocrine dysfunction/reduced libido/loss of menstrual period Edema and sweating Antipruritic therapy (eg, antihistamines) Endocrine monitoring; Testosterone replacement; Endocrine consultation Switch opioids* Constipation Treat prophylactically with stool softeners, bowel stimulants; Nonpharmacologic measures Dizziness Confusion Antivertigo agents Titrate dose *Opioid switching is an option for any adverse effect. *Opioid switching is an option for any adverse effect. Swegle JM, et al. Am Fam Physician. 2006;74(8): Swegle JM, et al. Am Fam Physician. 2006;74(8): ;

5 Anticipating and Managing Adverse Events Respiratory Depression The Most Serious Adverse Effect Emerging issues Hyperalgesia - An increased response to a normally painful stimulus - May occur at higher doses Sleep - Central and obstructive sleep apnea - Sleep architecture Most serious adverse effect associated with opioids is RESPIRATORY DEPRESSION Occurs when Initial doses are too high Therapy is titrated too rapidly Drug-drug interactions Opioids combined with other drugs that may potentiate opioid-induced respiratory depression - Benzodiazepines - Herbals - OTC preparations that contain diphenhydramine More common in patients with sleep apnea Respiratory depression may be fatal OTC, over-the-counter. Brush DE. J Med Toxicol Dec;8(4):387-92; Dimsdale JE et al. J Clin Sleep Med Feb 15;3(1):33-6 Manchikanti L, et al. Pain Physician. 2012;15(3 suppl):s67-s Opioid Therapy Ongoing Monitoring Reevaluating the Patient s Condition Reevaluate if the presentation changes to determine if opioid therapy continues to be effective or necessary ANALGESIA ADVERSE EFFECTS Reevaluate or refer if there is new pain The 4 A s Continue opioid therapy if appropriate analgesia and functional status improvements are maintained ACTIVITIES OF DAILY LIVING ABERRANT DRUG-TAKING BEHAVIORS Important to remember two other A s : Assessment and Action (treatment plan) Passik SD, et al. Adv Ther. 2000;17(2): What to Do if Your Patient Needs Treatment for Abuse and Addiction Referral Sources for Abuse and Addiction Treatment Know treatment centers in your area Work out a plan with the center you are referring to With a clear indication of abuse or addiction, discontinue prescribing of opioids Balancing Pain Management and Prescription Opioid Abuse Available at Find Substance Abuse and Mental Health Treatment Available at National Institute on Drug Abuse Available at American Council for Drug Education Available at

6 Summary Session III Summary Session III (cont d) What can you as a prescriber do? Use Patient Prescriber Agreements (PPAs) to help facilitate adherence and reduce opioid misuse and abuse Use clear and concise language to discuss PPAs Make sure you use PPA that patients can understand in their native language (eg, English, Spanish, Chinese, etc) Work with your patient to establish analgesic and functional goals for therapy Monitor patient adherence to treatment Talk to patients about UDTs and their results Anticipate adverse effects associated with ER/LA opioid analgesics and manage pro-actively Educate your patients on side effects and when to contact you so that you can collaboratively manage What can you as a prescriber do? Periodically assess benefits and side effects of therapy Reevaluate the patient s underlying medical condition if clinical presentation changes Identify referral sources in your area for the treatment of opioid abuse and addiction Use them to get your patients the detoxification and support services they need