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priate patients (i.e., only opioid-tolerant patients).• Preventing inappropriate conversion between fentanyl products.• Preventing accidental exposure to children and others for whomthe medication was not prescribed.• Educating prescribers, pharmacists, and patients about thepotential for misuse, abuse, addiction, and overdose.The REMS integrates available technology to help ensure appropriatepatient selection and education, checks and balances withinthe distribution channel, and dispensing of the medication for theappropriate, intended use. The ACTIQ and FENTORA REMS:• Ensures that appropriate patients have access to their medicineswhile preserving availability at retail pharmacies.• Enrolls prescribers and pharmacies through education aboutappropriate patient selection and additional key safety informationin order for patients to receive medications they need.• Enhances the dialogue about patient safety at the point of prescribingthrough required patient education about safe andappropriate use.• Uses existing and familiar technology within the normal pharmacystakeholder workow to minimize disruption.Elements of the approved ACTIQ and FENTORA REMS that willbe most relevant to healthcare professionals are the “MedicationGuide” and “Elements to Assure Safe Use.” The “Medication Guide”is an education tool for patients that contains specic, productrelatedinformation such as administration guidelines, warningsand contraindications, adverse events, and proper dosing writtenin easy-to-understand language for non-healthcare professionals.Healthcare professionals who prescribe these products will beresponsible for reviewing the “Medication Guide” with, and providinga copy of it to, each patient at the time FENTORA or ACTIQ isprescribed, and pharmacists dispensing these products will be requiredto provide the guide to each patient with each prescription.The “Elements to Ensure Safe Use” will require that FENTORA andACTIQ are accessed through a single, closed system that requiresstakeholders to complete specic education, assessment, andenrollment requirements (Figure 2).Healthcare professionals who want to prescribe FENTORA orACTIQ for outpatient use must enroll in the ACTIQ and FENTORAREMS program. Although prescriber enrollment is not required forinpatient use, it is required when healthcare professionals wishto prescribe FENTORA or ACTIQ upon patients’ discharge. Healthcareprofessionals may enroll online by accepting the program’srequirements and completing an education program and knowledgeassessment and an enrollment form. In addition, healthcare professionalsmust complete and sign a patient-prescriber agreementform for each new patient before the rst prescription is written.This form conrms that the patient is opioid tolerant and has beenreceiving around-the-clock treatment with an opioid medication formore than 1 week. It also acknowledges that the healthcare professionalhas provided and reviewed the “Medication Guide” with thepatient and that the patient has been informed about the risks,benets, and appropriate use of FENTORA or ACTIQ. The patientprescriberagreement form also must be signed by the patient.Pharmacies must assign a designated pharmacist to completea pharmacy-specic education program to train other pharmacystaff, a knowledge assessment, and an enrollment form. To ensurea controlled distribution model, the pharmacy will be eligible topurchase FENTORA and ACTIQ from enrolled distributors and dispensethese medications to eligible patients only upon completionof these steps. Furthermore, the existing pharmacy managementsystem (PMS) of enrolled pharmacies will be used to communicatewith the REMS database. Through this communication channel,prescriber enrollment and completion of the patient-prescriberagreement form can be veried instantly. Prescription labels willbe printed only once these conditions have been met. Enrollmentin the ACTIQ and FENTORA REMS program may be completedonline at www.ACTIQandFENTORArems.com. Enrollment mustbe renewed every 2 years or sooner in the event of major safetyupdates to the product labeling or major program changes.The ACTIQ and FENTORA REMS program is a controlled, integratedsystem that is designed to ensure the safe and appropriatedistribution, prescribing, and dispensing of these medications.Furthermore, the ACTIQ and FENTORA REMS program requireskey stakeholders to work collaboratively (Figure 3). Doing so willhelp to enhance the dialogue between healthcare professionalsand patients, preserve the local prescriber-pharmacy relationship,and coordinate patient counseling to support the safe useof FENTORA and ACTIQ.According to provisions of the ACTIQ and FENTORA REMS,beginning March 2012, all stakeholders will need to be enrolledin order for a prescription to be lled. Cephalon, Inc., is also participatingin the development of a class-wide REMS for all transmucosalimmediate-release fentanyl products. 36 Although the specicdetails of this REMS are under negotiation with the FDA, the systemis likely to be similar to that of the recently approved ACTIQ andFENTORA REMS. Once it is approved, Cephalon, Inc., will work toensure a smooth transition to the shared system while maintainingaccess to appropriate treatments for breakthrough pain in opioidtolerantpatients with cancer.ACKNOWLEDGMENTSThe clinical studies of fentanyl buccal tablet or OTFC mentioned inthis supplement were sponsored by Cephalon, Inc. (Frazer, Pennsylvania).Writing support was provided by Peloton Advantage, Parsippany,New Jersey, funded by Cephalon, Inc.SPONSORED BY CEPHALON, INC.,FRAZER, PENNSYLVANIACephalon | ADVANCE for NPs & PAs | 7ADVANCE for NPs & PAsG