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PARTNERING WITHPHARMACISTS:NALOXONEPRESCRIBING ANDDISPENSING TOPREVENT OVERDOSEDEATHS (AOAAM)Funding for this initiative was made possible (in part) by Providers' Clinical Support System for OpioidTherapies (grant no. H79TI023439) from SAMHSA. The views expressed in written conference materials orpublications and by speakers and moderators do not necessarily reflect the official policies of theDepartment of Health and Human Services; nor does mention of trade names, commercial practices, ororganizations imply endorsement by the U.S. Government.Je f frey B ra t be rg ,P h a rm D , B CP SCl i nic al P ro fe s soro f P h a rm ac yP ra c t i c eUn i ver sit y o fRh o de Is l a ndCo l lege o fP h a rm ac y2 5 Jun e 2 014
TARGET AUDIENCE The overarching goal of PCSS -O is to make available the mostef fective substance abuse treatments to serve patients in avariety of settings, including o steopathic physicians, familypractice physicians, pharmacists, and clinicians who practicein rural communities.
OBJECTIVES Identify the role naloxone has in opioidoverdose prevention and treatment List three ways to best educate patients andcaregivers on overdose management Describe the implementation of acollaborative practice agreement for naloxone(CPAN) in community pharmacies
EXISTING PARTNERSHIPS PHARMACISTS Prescription Monitoring Program (PMP) Opioid substitution therapies Methadone Buprenorphine Harm Reduction New needles Condoms Drug testing Referrals Dispense and counsel on prescription opioids
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PHARMACIES ARE IDEAL LOCATIONS FORPUBLIC HEALTH SERVICES Geography Hours Quantity Identity Marketing Greater access, especially vulnerablepopulations
Essential Services of Public Health Assure a competentworkforce Evaluate health services Research Develop policies andplans Enforce laws andregulations Link people to neededservices / assure care Monitor health status Diagnose andinvestigate Inform, educate, andempower Mobilize communitypartnerships
Self-identified barriers to the provision of healthpromotion and preventive services in currentpharmacy practiceLaliberte MC, et al. Ideal and actual involvement of community pharmacists in health promotion and prevention: a cross-sectional study in Quebec, Canada. BMCPublic Health 2012;12:192. http:/www.biomedcentral.com/1471-2458/12/192
EXISTING PARTNERSHIPS PHARMACISTS Six pharmacists from community- and clinic-based(HIV, substance abuse, pain) pharmacies interviewed Seattle, Boston, Pittsburgh Prescribers approached pharmacists Naloxone prescribing, dispensing and billing Public health model (no billing) Patients targeted High-dose opioids for pain High risk of overdose from rx/heroinBailey AM, Wermeling DP. Naloxone for opioid overdose prevention: Pharmacists' role in community-based practicesettings. Ann Pharmacother. 2014 Feb 12. [Epub ahead of print)
EXISTING PARTNERSHIPS PHARMACISTS Education “paramount” Caregiver competency in naloxone administrationundefined Reimbursement more difficult than provider /patientacceptance Public health – grant funding Clinics sometimes charged for service Best practice Medicaid coverage No coverage for atomizer as drug Prescription processing best at one pharmacyBailey AM, Wermeling DP. Naloxone for opioid overdose prevention: Pharmacists' role in community-based practicesettings. Ann Pharmacother. 2014 Feb 12. [Epub ahead of print)
PHARMACIST ROLES DIFFER BYPOSITION National Association leadership Pharmacy Benefitmanagers Corporate communitypharmacy leadership Veteran’s Affairs State Association leadership Pharmacists at thirdparty payers Universities/colleges ofpharmacy Health department Local Health department Hospital leadership Hospital pharmacyspecialists (ID, pain,substance abuse, ED,psychiatric) Clinic pharmacists Veteran’s Affairs Community independentpharmacists/owners Community corporatepharmacists
UTILIZE PRESCRIBING PATHWAYSPrescriber-Patient Rational opioidprescribing Pain contracts Naloxone co-prescribing OD education Addiction treatmentreferral Opioid substitutiontherapy Mental health referral EMR prompts / appsPatientPrescriberPharmacist
UTILIZE PRESCRIBING PATHWAYSPharmacist-Patient Risk recognition (PMP) Harm reductionPatient Replacement needles OD education Opioid substitution therapy Drug interactions Disease interactions Initiate naloxone (CPAN) EMR prompts / appsPrescriberPharmacist
UTILIZE PRESCRIBING PATHWAYSPrescriber-Pharmacist PMP communication Collaborative practiceagreement fornaloxone (CPAN) Stock naloxone kits Collaborate Insurance coverage Advocacy Education AwarenessPatientPrescriberPharmacist
RI PHARMACISTS OPINIONS OFNALOXONE AND OVERDOSE Feasibility of pharmacy -based naloxone intervention 21 pharmacy staf f (technicians and pharmacists) interviewedfrom Rhode Island Independent owner (n 2)Chain manager (n 4)Independent community pharmacist (n 3)Corporate community pharmacist (n 6)Pharmacy technician (n 6) Pharmacy -based naloxone could dramatically increase accessto this life-saving intervention Qualitative results presentedZaller N, Yokell M, Green T, et al. Feasibility of Pharmacy-Based Naloxone Distribution Interventions: A Qualitative Study with InjectionDrug Users and Pharmacy Staff in Rhode Island. Subs Use Misuse 2013; 48: 590-999.
RI PHARMACISTS OPINIONS OFNALOXONE AND OVERDOSE Pharmacists not aware of overdose prevalence Fatal overdoses are likely intentional – technician Pharmacists thought they stocked naloxone Was naltrexone Staf f interviewed thought that naloxone would increase riskbehaviors, “build up resistance” to naloxone Overall supported the intervention“ it’s one way to stop the cycle, even if one person out of1000 that actually could actually help maybe prevent anOD it would be wor th it. And to be honest, I think itcould be, depending on what programs, could be helpfulto [employer] financially, too ” – 29 yo corporatepharmacy managerZaller N, Yokell M, Green T, et al. Feasibility of Pharmacy-Based Naloxone Distribution Interventions: A Qualitative Study with InjectionDrug Users and Pharmacy Staff in Rhode Island. Subs Use Misuse 2013; 48: 590-999.
RI PHARMACY STAFF OPINIONS OFNALOXONE AND OVERDOSE Pharmacists interviewed compared intervention toexisting antidotes dispensed Glucagon for families of patients with diabetes Epinephrine auto-injector for caregivers of allergicpatients Intervention could be de-stigmatized if naloxoneprovided to both injection drug and prescriptionopioid usersZaller N, Yokell M, Green T, et al. Feasibility of Pharmacy-Based Naloxone Distribution Interventions: A Qualitative Study with InjectionDrug Users and Pharmacy Staff in Rhode Island. Subs Use Misuse 2013; 48: 590-999.
INTEGRATE NALOXONE INTO OPIOIDPRESCRIBING CULTURE Make the public aware Seatbelts Fire safety Helmets Implement best practices Immunization Herd immunity HIV/HCV testing/screening Maximize technology Make it routine, systematic, de -stigmatized
NALOXONE: STOCKING
NALOXONE An ANTIDOTE for OPIOID overdose Naloxone is an opioid receptor antagonist atmu, kappa, and delta receptors Works at the opioid receptor to displaceopioid agonists Shows little to no agonist activity Shows little to no pharmacological effect inpatients who have not received opioids
ONSET AND DURATION OF ACTION Naloxone takes effect in 3 to 5 minutes If patient is not responding in this time a second dose may need beadministered Naloxone wears off in 30 to 90 minutes Patients can go back into overdose if long acting opioids were taken(fentanyl, methadone, extended release morphine, extended releaseoxycodone) Patients should avoid taking more opioids after naloxoneadministration so they do not go back into overdose after naloxonewears off Patients may want to take more opioids during this time because theymay feel withdrawal symptoms The shelf-life of naloxone is 12-18 months – store at roomtemperature to minimize degradation
NALOXONE: STOCKINGAdmin ManufacturerNDCStrengthTotal volume How suppliedIM00409-1215-010.4 mg/ml0.4 mg/mlBox of 10single-dosefliptop vials67457-0292-020.4 mg/ml0.4 mg/mlBox of 10single-dosefliptop vials00409-1219-010.4 mg/ml4 mg/10 mlCase of 25multi-dosefliptop vials1 mg/ml2mg / 2 mlBox of 10Luer-Jet prefilledglasssyringes0.4 mg/ml0.4 mg/ml2 autoinjectors raIntranasalIMS/Amphastar Amphastar.com
NALOXONE: STOCKING Most major wholesalers carry naloxone formulations CAUTION: Assembly prior to use Do NOT draw up into syringes or screw glass vial into syringe Expiration date becomes 14 days instead of date on vials Storage IM - Store at 20 to 25 C (68 to 77 F); Protect from light IN - Store at 15 to 30 C (59 to 86 F); Protect from light Auto-IM – Store at 15 to 25 C (59 to 77 F) Mucosal atomizer devices (MAD) for intranasal administration Atomizes to particles 30-100 microns in size for mucosal absorption MAD300 - LMA MAD Nasal Intranasal Mucosal Atomization Devicewithout Syringe 25 devices/box Order: 1.866.246.6990 or 1.888.788.7999 Teleflex/LMA America – lmaems.com; Cardinal Health No NDC – durable medical equipment (DME)
INTRAMUSCULAR NALOXONE RESCUE KIT
IM NALOXONE: PRESCRIBINGwww.prescribetoprevent.org
INTRANASAL NALOXONE RESCUE KIT
IM NALOXONE: PRESCRIBINGwww.prescribetoprevent.org
NALOXONE PRESCRIPTIONINSTRUCTIONS Intramuscular Rx: Naloxone 0.4 mg/mL Quantity: 2-4 single-use1 mL vials or 1 X 10 mLmulti-use vial Sig: For suspected opioidoverdose, inject 1 mL inshoulder or thigh.Repeat after 3 minutesif no or minimalresponse. Refills: prescriberpreference Auto-IM Use as directed. Intra-Nasal Rx: Naloxone 1mg/1mL Quantity: 2-4 x 2 mLprefilled Luer-Jet LuerLock needleless syringe Sig: For suspected opioidoverdose, spray 1 mL(half of the syringe) intoeach nostril. Repeatafter 3 minutes if no orminimal response. Refills: prescriberpreference
EVZIO AUTO-INJECTOR
EVZIO AUTO-INJECTOR
EVZIO ADMINISTRATION INSTRUCTIONS EVZIO is user actuated and may be administered through clothing [e.g.,pants, jeans, etc.] if necessar y. Inject EVZIO while pressing into the anterolateral aspect of the thigh.In pediatric patients less than 1 year of age, pinch the thigh musclewhile administering EVZIO. Upon actuation, EVZIO automatically inser ts the needle intramuscularlyor subcutaneously, delivers the naloxone, and retracts the needle fullyinto its housing. The needle is not visible before, during, or af terinjection. Each EVZIO can only be used one time. If the electronic voice instruction system on EVZIO does not workproperly, EVZIO will still deliver the intended dose of naloxonehydrochloride when used according to the printed instructions on itslabel. The electronic voice instructions are independent of activating EVZIOand are not required to wait for the voice instructions to be completedprior to moving to the next step in the injection process.Evzio package insert. 4/2014.
EVZIO ADMINISTRATION INSTRUCTIONS Post-injection, the black base locks in place, a red indicatorappears in the viewing window and electronic visual and audibleinstructions signal that EVZIO has delivered the intended dose ofnaloxone hydrochloride. EVZIO’s red safety guard should not be replaced under anycircumstances. However, the trainer is designed for re-use andits red safety guard can be removed and replaced. It is recommended that patients and caregivers become familiarwith the training device provided and read the Instructions forUse; however, untrained caregivers or family members shouldstill attempt to use EVZIO during a suspected opioid overdosewhile awaiting definitive emergency medical care. Periodically visually inspect the naloxone solution through theviewing window. If the solution is discolored, cloudy, or containssolid particles, replace it with a new EVZIO. Replace EVZIO before its expiration date.Evzio package insert. 4/2014.
NALOXONE: BILLING
NALOXONE: BILLING Most major public and private insurers cover naloxoneformulations Prior authorization may be required Pharmacists perform real -time claim submission to determinecoverage Patients without insurance can buy prescribed naloxone 2 X 0.4 mg/ml single-use vials: 60 (May 2014) 2 X 2 mg/2ml single-use Luer-lock syringes 80 (May 2014) State vary in regard to over -the-counter IM syringe availabilityand quantity for purchase Mucosal atomizer devices Cost 5 each Billed as DME only Mechanism not usual practice
CPAN OVERVIEW
COLLABORATIVE PRACTICE AGREEMENTSDefinition: “A formal agreement in which a licensedprovider makes a diagnosis, supervises patient care,and refers patients to a pharmacist under a protocolthat allows the pharmacist to perform specific patientcare functions.” Also called Collaborative Drug Therapy Management (CDTM) Not associated with reimbursement Some agreements permit “initiation,” most permit “modify”
Patient care servicesprovided bypharmacists canreduce fragmentationof care, lower healthcare costs, andimprove healthoutcomes A 2010 study foundthat patient healthimproves significantlywhen pharmacistswork with doctors andother providers tomanage patient care
Centers for Disease Control and Prevention. Collaborative Practice Agreements and Pharmacists’ Patient Care Services: A Resource forPharmacists. Atlanta, GA: US Dept. of Health and Human Services, Centers for Disease Control and Prevention; 2013.
RI CPAN STEPS
CPAN IMPLEMENTATION STEPSMAY 2012 “EpidemiologicTrends in Rx OpioidAbuse andUnintentional OpioidPoisoning:Pharmacy - BasedInterventions forPatient Safety”Traci Green, Msc, PhD 70 pharmacistsattended
CPAN IMPLEMENTATION STEPSAUGUST 2012 “Rhode IslandOverdose DeathPrevention:Naloxone Accessand DistributionStrategy Day” JennyArnold, PharmD,BCPS Washington StateNaloxoneCollaborativePractice Agreement
CPAN IMPLEMENTATION STEPSSEPT 2012 University of Rhode Island College of Pharmacy Student TaraThomas ’13 develops 1-hour online Continuing ProfessionalEducation (CPE) Program with URI CPE Of fice“Opioids: Addiction, Overdose Prevention (Naloxone) andPatient Education.” Corporate pharmacy managers are approached, Walgreensagrees to participate Four locations are selected as CPA pilot sites located nearclusters of opioid overdose death reports RI Pharmacy Foundation funds ten pharmacists at thosestores to complete online CE for Naloxone CPA participationafter “initiation” waiver approved by Board of Pharmacy
CPAN IMPLEMENTATION STEPSOCT 2012 Rhode Island Board of Pharmacy unanimously approveswaiver to permit “initiation” of naloxone by pharmaciststrained using URI CE program, recognizing the epidemic ofoverdose deaths as a public health emergency.
CPAN IMPLEMENTATION STEPSNOV-FEB 2013 Walgreen’s corporate legaldepartment approves CPA Nov 2013: Naloxoneshortage Ten pharmacists completeonline training IM and IN naloxoneformulations and mucosalatomizer devices stockedat pharmacies CPA is signed by Jody Rich,MD and all pharmacists
CPAN IMPLEMENTATION STEPSJUNE 2013Michael Botticelli, Deputy Directorof the White House Of fice ofNational Drug Control andPrevention(ONDCP), holdsoverdose prevention roundtable inWoonsocket, RI in response to 14acetyl fentanyl heroin overdosedeaths between Feb-May (MMWR2013;62:703-4.)CPA extended to fifth Walgreen’sstore in Woonsocket and then toall 26 RI locations after Board ofPharmacy approval.
CPAN IMPLEMENTATION STEPSAUGUST-NOV 2013 Aug 2013 SAMSHA OpioidOverdose Prevention Toolkitreleased, RI CPA solutioncited 79 Walgreens pharmacistsfrom 26 stores completeonline CE training Nov 2013 100 Connecticutpharmacists trained in OpioidOverdose certificationprogram
IMPLEMENTATIONJAN-FEB 2014 Rhode Island Opioid overdosedeath rate doubled Media attention magnified State health departmentrecommends patient andcaregivers go to Walgreens toreceive naloxone and overdoseeducation February 2014 - Healthdepartment emergencyregulations released requiringbehavioral health staf f andpatients to be trained on anddispensed naloxone
CPAN IMPLEMENTATIONMARCH 2014 More emergency regulationsreleased with Boardconsultation giving allpharmacists the ability toprescribe naloxone andprescribers to dispensenaloxone Front-page Sunday ProvidenceJournal story on naloxone andpharmacy access Insurers, pharmacists,prescribers meet to discussnaloxone reimbursement CT stakeholder meeting
2014 AMERICAN PHARMACISTSASSOCIATION HOUSE OF DELEGATESControlled Substances and Other Medications with the Potentialfor Abuse and Use of Opioid Reversal A gents1 . APhA supports education for pharmacists and studentpharmacists to address issues of pain management, palliativecare, appropriate use of opioid reversal agents in overdose,drug diversion, and substance ‐related and addictive disorders .2. APhA supports recognition of pharmacists as the healthcare providers who must exercise professional judgment in theassessment of a patient’s conditions to fulfill correspondingresponsibility for the use of controlled substances and othermedications with the potential for misuse, abuse, fault/files/files/2014 Report of the APhA House of Delegates--Public—Final.pdf
2014 AMERICAN PHARMACISTSASSOCIATION HOUSE OF DELEGATESControlled Substances and Other Medications with the Potentialfor Abuse and Use of Opioid Reversal A gents3. APhA supports pharmacists’ access to and use ofprescription monitoring programs to identify and prevent drugmisuse, abuse, and/or diversion.4. APhA supports the development and implementation ofstate and federal laws and regulations that permitpharmacists to furnish opioid reversal agents to preventopioid‐related deaths due to overdose.5. APhA supports the pharmacist's role in selectingappropriate therapy and dosing and initiating and providingeducation about the proper use of opioid reversal agents toprevent opioid‐related deaths due to iles/files/2014 Report of the APhA House of Delegates--Public—Final.pdf
CPAN IMPLEMENTATION STEPSAPRIL 2014 Health Department recommends all pharmaciesstock naloxone and atomizers Board of Pharmacy approves CVS/Caremark CPAwaiver Naloxone initiation Participation of pharmacists with 2 years of workexperience One credit of CPE/year required to maintain CPAinstead of five Walgreens renews CPA with same terms
*projected for 2014 based on data as of May 2014.Graph courtesy Traci Green, PhD/RI Medical Examiners office.
KEY ELEMENTS OF CPAN
ELIGIBLE PATIENTS TO PARTICIPATE: Voluntarily requesting Does not have to be someone at risk of overdose- can be afriend, family member, etc. Recipient of emergency medical care for acuteopioid poisoning Suspected illicit or nonmedical opioid user High dose opioid prescription ( 100 morphine mgequivalents daily) Methadone prescription to opioid naïve patient
ELIGIBLE PATIENTS TO PARTICIPATE: Opioid prescription and: history of smoking COPD Respiratory illness or obstruction renal dysfunction or hepatic disease Known or suspected concurrent alcohol abuse Concurrent benzodiazepine prescription Concurrent SSRI or TCA anti-depressantprescription
ELIGIBLE PATIENTS TO PARTICIPATE: Recently released prisoners from a correctionalfacility Released from opioid detoxification ormandatory abstinence pr
EVZIO is user actuated and may be administered through clothing [e.g., pants, jeans, etc.] if necessary. . However, the trainer is designed for re-use and its red safety guard can be removed and replaced. It is r
