COUNSELING PATIENTS & CAREGIVERS ABOUT THE SAFE USE OF ER/LA OPIOID ANALGESICS

Transcription

1 COUNSELING PATIENTS & CAREGIVERS ABOUT THE SAFE USE OF ER/LA OPIOID ANALGESICS Unit IV Melvin Pohl, MD, FASAM Use Patient Counseling Document to help counsel patients Download ms/pdf/patient_counselin g_document.pdf Order hard copies o.com/pcd/submitorders.aspx Counsel Patients About Proper Use Explain Product-specific information about the prescribed ER/LA opioid How to take the ER/LA opioid as prescribed Importance of adherence to dosing regimen, how to handle missed doses, & to contact their prescriber should pain not be controlled Instruct patients/caregivers to Read the ER/LA opioid Medication Guide received from pharmacy every time an ER/LA opioid is dispensed Tell all their doctors about all medications they are taking FDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics Available at The ER/LA Opioid Analgesics Risk Evaluation & Mitigation Strategy. Selected Important Safety Information. Abuse potential & risk of life-threatening respiratory depression. 1

2 Counsel Patients About Proper Use Counsel patients/caregivers On the most common AEs of ER/LA opioids About the risk of falls, working w/ heavy machinery, & driving Call the prescriber for advice about managing AEs Inform the prescriber about AEs Prescribers should report serious AEs to the FDA eport/downloadforms/ucm pdf FDA-1088 FDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics Warn Patients Never break, chew, or crush an oral ER/LA tablet/capsule, or cut or tear patches prior to use May lead to rapid release of ER/LA opioid causing overdose & death When a patient cannot swallow a capsule whole, prescribers should refer to PI to determine if appropriate to sprinkle contents on applesauce or administer via feeding tube Use of other CNS depressants* w/ ER/LA opioids can cause overdose & death Use other CNS depressants, including other opioids, under the instruction of their prescriber *eg, sedative-hypnotics & anxiolytics, alcohol, illegal drugs FDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics Warn Patients ER/LA opioids AEs can lead to death Take exactly as directed Counsel patients/caregivers on risk factors, signs, & symptoms of overdose & opioid-induced respiratory depression, GI obstruction, & allergic reactions Call 911 or poison control TAKE 1 TABLET BY MOUTH EVERY 12 HOURS OXYCONTIN 10 MG TABLET Qty: 60 TABLETS Not to abruptly discontinue or reduce the ER/LA opioid Discuss how to safely taper the dose when discontinuing FDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics

3 Protecting the Community Caution patients Sharing ER/LA opioids w/ others may cause them to have serious AEs Including death Selling or giving away ER/LA opioids is against the law Store ER/LA opioids in a safe & secure place away from children, family members, household visitors, & pets Eg, a medication safe Protect ER/LA opioids from theft Dispose of any ER/LA opioids when no longer needed Read product-specific disposal information included w/ ER/LA opioid FDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics Source of Most Recent Rx Opioids Among Past-Yr Users Drug dealer 3.9% Other 5.0% >1 doctor 1.9% Bought on Internet 0.3% Bought/ took: friend/ relative 16.6% Free: friend/ relative 54.2% 1 doctor 18.1% SAMHSA. (2012). Results from the 2011 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-44, HHS Publication No. (SMA) Rockville, MD. Educate Patients & Families Rx medicines should only be taken when prescribed to you by a provider Taking a pill prescribed for someone else is drug abuse & illegal even just once Misusing Rx drugs can be as dangerous as illegal street drugs Mixing Rx opioids w/ alcohol or w/ sedatives/hypnotics is potentially fatal Apa-Hall P, et al. J Sch Nurs. 2008;24(suppl):S1-16. Paulozzi LJ, et al. Pain Med. 2012;13: Webster LR, et al. Pain Med. 2011;12 Suppl 2:S

4 Educate Parents Not in My House: What to Do Step 1: MONITOR Note how many pills in each prescription bottle or pill packet Keep track of refills for all household members If your teen has been prescribed a drug, coordinate & monitor dosages & refills Make sure friends & relatives especially grandparents are aware of the risks If your teen visits other households, talk to the families about safeguarding their medications The Partnership at DrugFree.org. Rx Abuse: Not in My House. Educate Parents Not in My House: What to Do Step 2: SECURE Do not store prescription meds in the medicine cabinet Keep meds in a safe place (eg, locked cabinet) Tell relatives, especially grandparents, to lock meds or keep in a safe place Encourage parents of your teen s friends to secure meds Step 3: DISPOSE Take inventory of all prescription drugs in your home Discard expired or unused meds The Partnership at DrugFree.org. Rx Abuse: Not in My House. ER/LA Opioid Drug Disposal 6 th National Prescription Drug Take-Back Day: Got Drugs? Saturday April 27, :00 AM to 2:00 PM Locations TBA Check back at drug_disposal/takeback/index.html Drug drop boxes in some local police departments or or To find a box near you 4

5 Prescription Drug Disposal Video demonstration: disposal.net/ index.html If take-back program or drop box unavailable, throw out in household trash Take drugs out of original containers Mix w/ undesirable substance Eg, used coffee grounds or kitty litter Less appealing to children/pets, & unrecognizable to people who intentionally go through your trash Place in sealable bag, can, or other container Prevent leaking or breaking out of garbage bag Before throwing out a medicine container Scratch out identifying info on label FDA. How to Dispose of Unused Medicines ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the- CounterMedicines/ucm pdf SMAR xt Disposal. A prescription for a healthy planet. Prescription Drug Disposal FDA lists especially harmful medicines in some cases fatal w/ just 1dose if taken by someone other than the patient Instruct patients to check medication guide Flush down sink/toilet if no available take-back program As soon as they are no longer needed So cannot be accidentally taken by children, pets, or others Includes transdermal adhesive skin patches Used patch worn for 3 d still contains enough opioid to harm/kill a child Dispose of used patches immediately after removing from skin Fold patch in half so sticky sides meet, then flush down toilet Do NOT place used or unneeded patches in household trash Exception is Butrans: can seal in Patch-Disposal Unit provided & dispose of in the trash ucm htm Disposal Updates In Dec 2012, DEA published a Notice of Proposed Rulemaking for Disposal of Controlled Substances The Secure & Responsible Drug Disposal Act of 2010 would expand options to collect controlled substances from ultimate users for disposal to include: Take-back events Mail-back programs Collection receptacle locations Check back at DEA. Federal Register. 2012; 77(246): Proposed Rules. Disposal of Controlled Substances. 5

6 CO*RE Case: Anne, 47 Year Old Female Case: Anne Anne has ovarian cancer Stable disease based on recent imaging Stable pain management for 1 yr w/ hydromorphone ER 12 mg q24h Last 2 months she asked for a renewal prescription 5-7 days early Query your state PDMP: she has not been doctor shopping When questioned: did not realize she was requesting refills early Collect urine sample: send to lab for pain management panel that includes hydromorphone, opiates, & drugs of abuse She reports no change in her pain control Current regimen is still effective ARS: Unit 4.1 Anne: What Would You Do Next? A. Refuse to give her a refill until the correct time B. Make her next prescription for only 2 weeks & have her bring in her pill bottles for a count at next visit C. Ask where she keeps her medications & how she secures them 6

7 Anne: Interview Anne reports that she keeps her medications in her purse on top of the refrigerator Further questioning reveals that her niece & nephews have recently visited her home more often than usual ARS: Unit 4.2 Anne: Now What Would You Do? A. Only prescribe 2 wks of hydromorphone ER at a time & request she brings in her prescription bottles for pill counts at each visit B. Stress to her the safety concerns when ER/LA opioids are taken by someone for whom they are not prescribed; request she brings her prescription bottles for pill count next visit C. Call the police Anne: Case Summary Explain to Anne ER/LA opioids are extremely harmful can be fatal w/ just 1 dose if taken by someone other than the patient She is responsible to store medication in a safe & secure place away from children, family members, & visitors If she cannot safeguard her medications, you will consider an alternative therapy You will not provide early renewal of prescription again At the next visit UDT positive for hydromorphone (negative other drugs) Anne reports she Purchased a medication safe that same day Counts her medication daily Spoke to her sister RE concerns about her niece/nephews 7

8 ASAM Case: Paul 51 Year Old Male Physician Case: Paul 51 year-old male physician Diagnosis: DJD spine with spur Cervical fusion 2010 Medications: Fentanyl patch 25 mcg q 3 days, carisorprodal 325 mg tid, pregablin 100mg hs, hydromorphone or oxycodone for breakthrough Depressed, anxious, insomnia, angry and frustrated Medical board intervened and mandated assessment Treatment involved medically managed withdrawal, CBT, DBT, physical therapy, group and individual counseling, yoga, stretching and mindfulness meditation. Case: Paul ARS: Unit 4.3 What single factor would justify continuing his current LA/ER opioid program? A. Lack of active addiction B. Favorable side effect profile C. Congruent urine toxicology and PMP report D. Objective improvement in functional capacity E. No evidence of cognitive impairment 8

9 Case: Paul Take homes: Did he have addiction? Pain on medications was 5-7 Pain off medications was 2-3 Needed to deal with emotional aspect of chronic pain syndrome Function improved off opioids function was impaired on opioids hard to see the forest for the trees 9