There are no financial or other pertinent conflicts of interest to disclose. Learning Objectives: Key Questions To Ask 10/4/2014

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1 Maintaining Patient Safety When Chronic Opioid Therapy Is Prescribed P. David Pacheco, Ph.C, PA-C, CAAAPM Pain Medication Management Specialist Southwest Interventional Pain Specialists, PC 4700 Jefferson NE Suite 700, Albuquerque NM There are no financial or other pertinent conflicts of interest to disclose. Assistant Clinical Pharmacy Professor College of Pharmacy University of New Mexico, Albuquerque, NM Learning Objectives: Identify four of the most prevalent extended release opioid formulations dispensed by retail pharmacies. Name three Risk Evaluation and Mitigation Strategy (REMS) expected results for prescriber education regarding opioid therapy using extended release/long acting formulations. Name the four treatment requirements identified on the New Mexico protocol for pharmacist prescribing opioid overdose reversal medication. List at least two possible pharmacist initiated safety measures that can be implemented to ensure safe and effective use of opioid medication. Self Assessment Questions True or False: There is a growing harmful trend regarding the prescribing and misuse of opioid medication in the United States and the state of New Mexico. True or False: All patients who are prescribed chronic opioid therapy are addicts or will become addicted. True or False: Pharmacists are not able to play a significant role in maintaining safe and effective use of chronic opioid therapy since they do not typically prescribe those types of agents. Key Questions To Ask What is the problem? What is the magnitude of the problem? What can we do to help fix the problem? 1

2 CDC. Vital Signs: Overdoses of Prescription Opioid Pain Relievers United States, MMWR 2011; 60: 1-6 New Mexico Dilemma Prescription Drug Overdose State Rates State (Population) Drug overdose ageadjusted death rate per 100,000 people in 2008 Kilograms of prescription painkillers sold, rates per 10,000 people in 2010 Iowa (3,090,416) Michigan (9,895,622) New Mexico (2,085,2087) CDC. Vital Signs: Overdoses of Prescription Opioid Pain Relievers United States, MMWR 2011; 60: 1-6 (Population based on estimations for 2013) 2

3 Where are patients getting these? Higher opioid prescribing Increased availability Increased risk for unwanted outcomes Substance Abuse and Mental Health Services Administration. Results from the 2010 National Survey on Drug Use and Health: volume 1: summary of national findings. Rockville, MD: Substance Abuse and Mental Health Services Administration, Office of Applied Studies; Available from URL: Present Opioid Dilemma Centers for Disease Control (CDC) and Prevention - CDC Newsroom Press Release March 3, 2014 Physicians are a leading source of prescription opioids for the highest-risk users (patients at highest risk for overdose). Sources of Prescription Opioid Pain Relievers by Frequency of Past-Year Nonmedical Use: United States, , - Journal of the American Medical Association Internal Medicine (JAMA Internal Medicine) Opioids drive continued increase in drug overdose deaths Centers for Disease Control (CDC) and Prevention - CDC Newsroom Press Release February 20, 2013 Drug overdose deaths increased for the 11th consecutive year in Overdose deaths involving opioid analgesics began with 4,030 deaths in 1999, the number of deaths increased to 15,597 in 2009 and 16,651 in Pharmaceutical Overdose Deaths, United States, 2010, - Journal of the American Medical Association (JAMA) How is this being addressed? On July 9, 2012, the U.S. Food and Drug Administration (FDA) approved a risk management program, known as a Risk Evaluation and Mitigation Strategy (REMS), for... extended-release and long-acting (ER/LA) opioid analgesics. This required that companies who manufactured ER/LA opioid analgesics had to make available training for health care professionals who prescribe ER/LA opioid analgesics on proper prescribing practices and also to distribute educational materials to prescribers and patients on the safe use of these powerful pain medications. This goes beyond requirements in the drug prescribing information. REMS Requirement The expected results of prescriber education in REMS: Understand how to assess patients for treatment with ER/LA opioid analgesics. Be familiar with how to initiate therapy, modify dose, and discontinue use of ER/LA opioid analgesics. 3

4 REMS Requirement Be knowledgeable about how to manage ongoing therapy with ER/LA opioid analgesics. Know how to counsel patients and caregivers about the safe use of ER/LA opioid analgesics, including proper storage and disposal. Be familiar with general and product-specific drug information concerning ER/LA opioid analgesics. What role can the pharmacist play in this dilemma? New Mexico pharmacists may now prescribe opioid overdose reversal medication. New Mexico is the first state to authorize pharmacists to prescribe naloxone under a protocol developed by the New Mexico Board of Pharmacy. The protocol addresses: Pharmacist Education/Training Consent Screening Prescriber Notification PHARMACIST PRESCRIPTIVE AUTHORITY OF NALOXONE RESCUE KIT PROTOCOL E. Guidelines a. Pharmacist Education/Training 1. Participating Pharmacists will successfully complete a certification prescriptive authority training approved by the Board of Pharmacy and maintain this certification with the Board of Pharmacy by completing 2 hours of live continuing education in this area every two years. 2. A primary option of an NRK may include the following contents (the pharmacy will be responsible for the assembly of the NRKs): i. Naloxone 2mg/2ml syringes ii. Intranasal trumpet device iii. Educational handout 3. Other secondary options of NRKs as approved by the FDA may be used. b. Consent/Screening/Prescriber Notification 1. Patient is screened and evaluated by the Pharmacist for the risk of overdose. 2. Patient consent form must be completed and signed before the prescribing and dispensing of NRK. 3. Notify the patient s primary care provider with the consent of the patient (if available) within 15 days of the original prescription. Naloxone is administered by attaching a nasal-tip inhaler to a small vial, which is used to spray a mist into the nose membrane. The drug flows directly to the brain, blocking opioids and restoring breathing. Suboxone prescribed by pharmacists? This has been discussed recently in prescriber circles. Rationale: It is often very difficult to locate a prescriber willing to take on new patients. Appointment times for care are often impossible for those who work full-time. It would allow for a significant increase in the availability for care. Clinics would be structured similar to any other pharmacy run outpatient clinic. New Mexico Prescription Monitoring (PMP) Useful tool utilized by pharmacists and prescribers when issuing opioid medication Only effective if actually used by prescriber Not all pharmacies report consistently Not all prescribers utilize the program Dentist are now being asked to utilize this tool w being asked by their governing board to utilize this tool 4

5 Attitude changes are desperately needed Not all patients prescribed opioid medication for legitimate chronic pain conditions are addicts. If addicts are identified, they need treatment just as with any other disease state. Until the disease is treated the behavior will more than likely continue. Encourage suspected addicts to seek assistance rather than simply shunning them, even if repeated multiple times. Have information regarding addiction treatment readily available. Clinic Monitoring Initial assessment is crucial to determine if the patient is or is not a good candidate for opioid therapy. Controlled Substance Agreement The PMP report is pulled prior to any dispensing of opioid medication. Drug tox screening is done at the start of therapy and periodically during treatment. Clinic Monitoring Monthly visits are scheduled for all on chronic opioid therapy. ANY suspected aberrant behavior identified, even if reported from outside the clinic, is grounds for discharge. Pill counts are completed at each visit. If no pain medication is remaining or the count is short due to selfmedicating the patient is discharged. If the patient does not bring in their remaining pain medication a new order is not issued until a count can be completed. Pharmacy PMP - do not fill opioid orders Monitoring until this has been verified and report all opioids dispensed. If the opioid prescription presented appears suspicious call the provider. Don t leave the problem solving to the patient. If the patient presents in a concerning manner or you feel uncomfortable with a particular patient due to their past behavior call the provider. Pharmacy Monitoring Be respectful but speak frankly to patients when addressing suspected misuse of opioid medication. The pharmacist may be the only readily available health care professional a patient may have direct access to. Have written information available to patients regarding substance abuse treatment. Let patient s know opioid taper treatment is available through their prescriber. Possible Treatment Venues for Addition Desert Oasis Recovery - Presbyterian Health Services Albuquerque Metropolitan Central Intake - University of New Mexico Turquoise Lodge - New Mexico Department of Health 5

6 Presentation Summary There is a definite opioid abuse problem the health care system is facing. Safety measures are being implemented to minimize the danger chronic opioid treatment poses. Pharmacists have and may have an even a greater role in opioid addiction treatment in the future. Patients suffering from addiction need your help not a cold shoulder. Become better acquainted with the prescribers of chronic opioid medication and address any concerns you may identify. Self Assessment Questions There is a growing harmful trend regarding the prescribing and misuse of opioid medication in the United States and the state of New Mexico. - TRUE All patients who are prescribed chronic opioid therapy are addicts or will become addicted. - FALSE Pharmacists are not able to play a significant role in maintaining safe and effective use of chronic opioid therapy since they do not typically prescribe those types of agents. - FALSE Questions pdp340@hotmail.com (cell) Southwest Interventional Pain Specialists