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Buprenorphine: A Guide for NursesStates that allow them to prescribeSchedule III, IV, or V drugs.Physicians may be consideredqualified to prescribe buprenorphineproducts if they: Meet at least one of the followingtraining requirements:– Hold a subspecialty boardcertification in addictionpsychiatry from the AmericanBoard of Medical Specialties;– Hold a certification from theAmerican Society of AddictionMedicine (ASAM);– Hold a subspecialty boardcertification in addiction medicinefrom the American OsteopathicAssociation;– Have completed not less than8 hours of authorized training onthe treatment or management ofopioid-dependent patients. Thistraining may include classroomsituations, seminars atprofessional society meetings,electronic communications, orother media; AND meet both of the followingcriteria:– Have the capacity to provide or torefer patients for necessaryancillary services, such aspsychosocial therapy; and– Agree to treat the applicablenumbers of patients (30 or 100) intheir individual or group practice(DATA 2000; Office of NationalDrug Control PolicyReauthorization Act of 2006(ONDCPRA—Public Law109-469)).Originally, waivered physicians werelimited to treating no more than30 patients with approved4buprenorphine products at any onetime under DATA 2000, and physiciangroup practices were also limited to30 patients. The physician grouppractice limit was eliminated byPublic Law 109-56, effective August 2,2005, so that each physician in agroup practice, like a physician in solopractice, was permitted to treat up to30 patients at any given time.Under the ONDCPRA, effectiveDecember 29, 2006, physicians whomeet the following criteria may notifythe Secretary of HHS of their needand intent to treat up to 100 patientsat any one time. To meet therequirements, (1) the physician mustcurrently be qualified under DATA2000, (2) at least 1 year must haveelapsed since the physician submittedthe initial notification forauthorization, (3) the physician mustcertify his or her capacity to referpatients for appropriate counselingand other appropriate ancillaryservices, and (4) the physician mustcertify that the total number ofpatients at any one time will notexceed the applicable number.The SAMHSA BuprenorphineInformation Center has informationspecialists available to answerquestions about buprenorphine andDATA 2000 on weekdays from8:30 a.m. to 5:00 p.m., Eastern time.The Information Center may bereached by telephone at 866–287–2728or by e-mail atinfo@buprenorphine.samhsa.gov.SAMHSA will communicate with theDrug Enforcement Administration(DEA) in the Department of Justice,review the notification, and inform theDEA whether or not the physician isqualified as required by DATA 2000.The DEA will issue a unique

Backgroundidentification number that indicatesthat the physician is qualified underDATA 2000. The physician then willbe authorized to dispense and/orprescribe under the authority of his orher DEA practitioner registration.CSAT will send the physician a letterwith the newly assigned DEAidentification number. A new DEAregistration certificate will be issuedto the physician that documents thenew DEA number that must bewritten on buprenorphineprescriptions as well as the originalDEA registration number assigned tothe physician.DATA 2000 only permits physicians toprescribe and dispense approvedopioid medications for the treatmentof addiction. At this time, onlySubutex (buprenorphine) andSuboxone (buprenorphine/naloxone)have been approved for office-basedtreatment. Physicians are specificallyprohibited from delegating prescribingopioids for detoxification and/ormaintenance purposes tononphysicians (i.e., Advanced PracticeNurses (APNs), Nurse Practitioners(NPs), and Physician Assistants(PAs)).Since 2001, SAMHSA has beenresponsible for monitoring andregulating the use of opioidmedications in treatment withmethadone and buprenorphine. Sincethe implementation of DATA 2000,SAMHSA can provide office-basedphysicians a waiver to prescribeSchedule III, IV, and V medicationssuch as Subutex (buprenorphine) andSuboxone (buprenorphine andnaloxone) in their office settings(CSAT, 2004).5

Buprenorphine and the Role of theNurseCurrently, advanced practice nurses andNPs may not prescribe or dispensebuprenorphine products for the treatmentof addiction even in States that allow themto prescribe scheduled medications undercertain controls, supervisions, and otherrestrictions. This guide will highlight theaddictions management skills of nurses andpromote a mutually respectful teamenvironment in which nurses andphysicians collaboratively work to improvethe care provided to individuals who areaddicted to opioids. This care may includeassessment, induction, stabilization,maintenance, monitoring, addictioncounseling, and relapse prevention.The nurse’s roles with patientsreceiving buprenorphine for thetreatment of addiction (1) may besubject to State practice regulations and(2) may include, but not be limited to: Conducting screening, assessment,treatment monitoring, counseling,and supportive services; Educating patients, their familymembers, or other supportiveindividuals about buprenorphinetherapy as well as risks, benefits,potential side effects, interactions,program requirements, consents,and treatment contracts; Involving patients in thedevelopment of the treatment plan,and working with the patient andthe interdisciplinary team toindividualize the plan for meetingthe patients’ needs; Enhancing treatment readiness,supporting treatment completion,ensuring safety, and promotingsustained recovery outcomes forindividuals undergoing buprenorphinetreatment for opioid addiction; Improving access, identifyingcommunity resources, and providinginformation about them; andexplaining reimbursement options foroffice-based buprenorphine treatment; Assisting patients in accessing careelsewhere when the present practiceis not a suitable option for them; and Assisting patients in accessing othertreatment options as needed (e.g.,day treatment, residential,outpatient, methadone detoxificationor maintenance, etc.).More detailed information is availablein Clinical Guidelines for the Use ofBuprenorphine in the Treatment ofOpioid Addiction, SAMHSA’sTreatment Improvement Protocol(TIP) #40 (CSAT, 2004). Theguidelines cover screening,assessment, and diagnosis of opioiddependence and its associatedproblems. The guidelines also containdetailed protocols for the use ofbuprenorphine under a variety ofclinical scenarios, including the use ofbuprenorphine with patients who areexperiencing co-occurring pain orpsychiatric disorders, or chemicaldependency involving more than onesubstance.7

Buprenorphine PharmacologyGeneral Opioid PharmacologyOpioid ReceptorsOpioid receptors are molecules on thesurface of cells to which opioidcompounds attach and through whichthey exert their effects. Three differenttypes of opioid receptors are present inthe brain: mu, kappa, and delta. Two ofthese opioid receptors (mu and kappa)are also found in the spinal cord andmediate pain transmission at this levelof the nervous system, i.e., from theperiphery to the brain. The receptormost relevant to opioid abuse andtreatment is the mu receptor. It isthrough activation of the mu receptorthat opioids exert the majority of theiranalgesic (pain-relieving property),euphorigenic (euphoria or “high”), andaddictive effects (CSAT, 2004).Although the mu receptor is, as noted,the most relevant to opioid abuse andtreatment, the kappa and deltareceptors are also responsible for opioidaddiction.The Functions of Opioids at ReceptorsOpioids can interact with receptors indifferent ways. Three types ofdrug/receptor interactions are agonists(or full agonists), antagonists, andpartial agonists (CSAT, 2004).Full AgonistsDrugs that activate receptors in thebrain are termed agonists. Agonistsbind to receptors and turn them on,thereby producing an effect in theorganism. Full mu opioid agonistsactivate mu receptors. Opioids withthe greatest abuse potential are fullagonists (e.g., morphine, heroin,methadone, oxycodone,hydromorphone) (CSAT, 2004).AntagonistsAntagonists also bind to opioidreceptors, but instead of activatingreceptors, they effectively block them.An antagonist is like a key that fits ina lock but does not open it andprevents another key from beinginserted to open the lock. Examples ofopioid antagonists are naltrexone andnaloxone (CSAT, 2004).Partial AgonistsPartial agonists possess some of theproperties of both antagonists and fullagonists. Partial agonists bind toreceptors and activate them, but not tothe same degree as do full agonists. Atlower doses and in individuals who arenot dependent on opioids, full agonistsand partial agonists produce effects thatare indistinguishable. As doses areincreased, both full and partial agonistsproduce increasing effects. At a certainpoint, however, the increasing effects ofpartial agonists reach maximum levelsand do not increase further, even ifdoses continue to rise—”the ceilingeffect.” As higher doses are reached,partial agonists can act like9

Buprenorphine: A Guide for Nursesantagonists—occupying receptors butnot activating them (or only partiallyactivating them), while at the sametime displacing or blocking full agonistsfrom receptors. Buprenorphine is anexample of a mu opioid partial agonist(CSAT, 2004).Consequences of RepeatedAdministration and Withdrawal ofOpioid DrugsThe repeated administration of a muopioid agonist results in tolerance anddose-dependent physical dependence.Tolerance is characterized by adecreased subjective and objectiveresponse to the same amount ofopioids used over time or by the needto keep increasing the amount used toachieve the desired effect. In the caseof abuse or addiction, the desiredeffect typically is euphoria. Physicaldependence is manifested as a set ofwithdrawal signs and symptoms inresponse to reduction, cessation, orloss of the active compound atreceptors (withdrawal syndromes).Typical signs and symptoms of theopioid withdrawal syndrome includelacrimation (tears), diarrhea,rhinorrhea, piloerection (goose flesh),yawning, cramps and aches, pupillarydilation, and sweating. In anindividual who otherwise is in goodgeneral health (e.g., with no history ofsignificant cardiovascular disease),opioid withdrawal is not lifethreatening. Patients withcardiovascular disease or other severeconditions will need comanagementinvolving the appropriate specialist, aswell as consultation with an addictionspecialist (CSAT, 2004). The primarydistinguishing characteristic thatdifferentiates dependence fromaddiction, as outlined in theDiagnostic and Statistical Manual IV(Text Revision) (DSM-IV-TR) (APA,102000) criteria, is the behavioralcomponent of continued use despitenegative consequences.Two types of withdrawal areassociated with mu opioid agonists:spontaneous withdrawal andprecipitated withdrawal.Spontaneous WithdrawalSpontaneous withdrawal can occurwhen an individual who is physicallydependent on mu agonist opioids (e.g.,has been using opioids on a dailybasis) suddenly discontinues thatopioid use. It also can occur if anindividual who is physicallydependent markedly decreases his orher daily opioid use. In an individualwho is physically dependent on heroin,spontaneous withdrawal usuallybegins 6–12 hours after the last doseand peaks in intensity 36–72 hoursafter the last use. The spontaneouswithdrawal syndrome from heroinlasts approximately 5 days, although amilder, protracted withdrawal maylast longer. Other short-acting opioids,such as oxycodone and hydrocodone,have kinetic profiles that are similarto heroin, and the time course ofspontaneous withdrawal for theseagents should be similar to thatdocumented for heroin. Opioids withlonger half-lives have a longer periodbefore the onset of spontaneouswithdrawal (e.g., 24–72 hours formethadone) and a longer period beforepeak withdrawal is experienced(CSAT, 2004).Precipitated WithdrawalPrecipitated withdrawal usuallyoccurs when an individual who isphysically dependent on opioids isadministrated an opioid antagonist. In

Buprenorphine Pharmacologyan individual who is not physicallydependent on opioids, the acuteadministration of an antagonisttypically produces no effects. In anindividual who is physicallydependent on opioids, however, anantagonist produces a syndrome ofwithdrawal that is qualitativelysimilar to that seen with spontaneouswithdrawal (although the onset isfaster and the syndrome is shorter,depending on the half-life of theantagonist). One way to conceptualizeprecipitated withdrawal is that theantagonist displaces agonists fromreceptors, but because the antagonistdoes not activate the receptor, there isa net decrease in agonist effect,resulting in withdrawal. It is alsopossible for partial agonists toprecipitate withdrawal. If anindividual who is physicallydependent on opioids receives an acutedose of a partial agonist, the partialagonist can displace the full agonistfrom the receptors, yet not activate thereceptors as much as the full agonisthad. The net effect would be adecrease in agonist effect and aprecipitated withdrawal syndrome.Precipitated withdrawal with a partialagonist is more likely to occur in anindividual who has a high level ofphysical dependence (e.g., high use ofopioids each day), who takes thepartial agonist soon after a dose of fullagonist, and/or who takes a high doseof the partial agonist (CSAT, 2004).Affinity, Intrinsic Activity, andDissociationThe strength with which a drug bindsto its receptor is termed its “affinity.”The degree to which a drug activatesits receptors is termed its “intrinsicactivity.” Affinity for a receptor andactivation of the receptor are twodifferent qualities of a drug. A drugcan have high affinity for a receptorbut not activate the receptor (e.g., anantagonist). Mu opioid agonists,partial agonists, and antagonists canvary in their affinity. In addition tovariation in affinity and intrinsicactivity, drugs also vary in their rateof dissociation from receptors.“Dissociation” is a measure of thedisengagement or uncoupling of thedrug from the receptor. Dissociation isnot the same as affinity—a drug canhave high affinity for a receptor (it isdifficult to displace it from thereceptor with another drug once thefirst drug is present), but it stilldissociates or uncouples from thereceptor with some regularity.Buprenorphine’s slow dissociationcontributes to its long duration ofaction (CSAT, 2004).Characteristics of Abused DrugsThe rate of onset of thepharmacological effects of a drug, andthereby its abuse potential, isdetermined by a number of factors.Important among these are the drug’sroute of administration, its half-life,and its lipophilic property (whichdetermines how fast the drug reachesthe brain). A faster route of drugadministration (e.g., injection,smoking), a shorter half-life, and afaster onset of action are associatedwith a higher abuse potential of adrug. With all classes of drug

Purpose of This Guide . This guide is intended to provide nurses (including Registered Nurses (RNs), Licensed Practical Nurses (LPNs), and Nurse Practitioners (NPs)) with general information about buprenorphine products—Suboxone (buprenorphine and naloxone) and Subutex (buprenorphin