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Formulary AUGUST 2013 PP. 243–276August 2013VOL. 48, NO. 8PAGES 243–276A peer-reviewed drug management journalfor managed care and hospital decision-makersPEER-REVIEWEDNEWS CAPSULESCover ArticleORAL ONCOLYTICS MEDICATION RECONCILIATION FROM A SAFETY PERSPECTIVE AMERICAN DIABETES ASSOCIATION MEETING COVERAGEOral oncolytics: Assessing value ofnewer agents versus current standardsof care as part of P&T processSalome Bwayo Weaver, PharmD; Clarence Moore, PharmD; Vicky Shah,PharmD candidate; Maritsa Serlemitsos-Day, PharmD, BCPS258Oral oncolytics are relatively new to the field of cancer therapy. Theycurrently make up about 25% of the oncology market and their useis continually expanding. The current insurance system is not efficiently equippedto handle the rapid expansion of oral oncolytics into the market, and the currentinsurance benefit design contributes significantly to access issues for patients. Thisarticle offers formulary decision makers information needed to evaluate newer oraloncolytic therapies compared with existing standards of care using guidelines fromthe National Comprehensive Cancer Network . The oral agents discussed are limitedto those introduced into the market since 2007.243Aromatase inhibitor added tobreast cancer prevention guideline How to save 200B annually indrug costs Concomitant control ofBP Canagliflozin economic analysis Adherence varies across marketsegments Triptans contraindicatedin patients with CV conditions Episodic migraine progresses to chronicmigraine without optimal treatment Unauthorized prescribers Estrogentherapy in hysterectomized women Flu season preparednessFDA DRUG APPROVALS256 New molecular entity:Medication Safety and Reliabilitydimethyl fumarate Pipeline previewgeneric approvals FDAactions in briefExamining medication reconciliationfrom a perspective of safetyMEETING COVERAGEPEER-REVIEWED First-time271Michael Daly, PharmD, MSCI, BCPSBrian Lee, PharmD266The impact of medication reconciliation efforts on patient safetyremains largely unknown. Recently published, systematically reviewedevidence suggests that there are certain characteristics of medication reconciliationprocesses that correlate favorably with clinically important patient safety outcomes.These include utilizing a pharmacist-driven process and possibly focusing efforts ontargeted, high-risk patient populations. Structured medication reconciliation acrosstransitions in care that has support from administration has not only been linked tohigh-performing hospitals, but also has been identified as one area in which healthinformation technology experts expect the most financial andclinical value in the future. Hospitals and managed care providers tasked with allocating resources aimed at optimizing patientsafety while containing costs should carefully consider investingin this type of pharmacist-driven, medication reconciliationprocess.The latest diabetes clinicalnews from the American Diabetes Association 73rd Scientific Sessions275 POLICY WATCHBreakthrough therapy:FDA’s new designationVOL. 48, NO. 8FORMULARYJOURNAL.com FACEBOOK.com/FORMULARY TWITTER.com/FORMULARY NEWS

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News CapsulesWHAT’S NEW IN DRUG RESEARCHAND MANAGED CARE PHARMACYGuideline adds aromatase inhibitor for breastcancer preventionfrom Staff ReportsTake awayExemestane is not for everypatient, but is an option for primaryprevention of breast cancer in postmenopausal women with increasedrisk of invasive breast cancer.The new update to the 2009 American Society of Clinical Oncology(ASCO) guideline on the pharmacologic interventions for breast cancerrisk reduction now lists aromataseinhibitor exemestane (Aromasin,Pfizer) as an option for postmenopausal women for primary risk reduction who are at an increased risk ofdeveloping invasive breast cancer.The updated guideline, Use ofPharmacologic Interventions forBreast Cancer Risk Reduction:American Society of Clinical Oncology Clinical Practice Guideline, waspublished in the Journal of ClinicalOncology. The original guideline waspublished in 1999 and was previouslyupdated in 2002 and 2009.Previous guidelines had suggesteddiscussing prophylactic use of raloxifene (Evista, Lilly) in postmenopausalwomen at risk for breast cancer andtamoxifen in both pre- and postmenopausal women at risk. Earlierguidelines stressed that use of aromatase inhibitors as prevention was notrecommended outside of clinical trials.The key recommendations of theguideline are: Tamoxifen (20 mg per day orallyfor 5 years) should be discussed as anoption to reduce the risk of invasive,estrogen receptor (ER)-positive breastcancer in premenopausal or postmenopausal women. Tamoxifen targets theestrogen receptor in breast tissue, andis therefore only effective for prevention of ER-positive breast cancer. Raloxifene (60 mg per day orallyfor 5 years) should also be discussedas an option to reduce the risk ofinvasive, ER-positive breast cancer. Italso targets the estrogen receptorin breast tissue. Its use is limited topostmenopausal women. Exemestane (25 mg per dayorally for 5 years) should be discussedas an alternative to reduce the risk ofinvasive, ER-positive breast cancerin postmenopausal women. It is anfacebook.com/Formularytwitter.com/Formulary NewsAugust 2013 VOL. 48, NO. 8FormularyJournal.com Editorial MissionTo provide timely, accurate,and practical drug-relatedinformation to assist our readersin their drug managementresponsibilities—evaluating drugsfor the formulary and developingpolicies and procedures to guidethe appropriate, rational, safe,and cost-effective use of drugs.Formulary is abstractedor indexed in the followingreference sources:CINAHLCurrent ContentsEMBASE/Excerpta Medica (online)HEALTH (online)Hospital Literature IndexInpharmaInternational PharmaceuticalAbstractsaromatase inhibitor, a class of drugsthat lower the amount of estrogenin postmenopausal women and aregiven to women with ER-positivebreast cancer after surgery to lowerthe risk of the cancer coming back.While exemestane is approved for thetreatment of breast cancer, the FDAhas not yet approved its use in breastcancer prevention. This recommendation is based on encouraging datafrom a single clinical trial that showedup to a 70% reduction in overall andER-positive invasive breast cancerincidence with exemestane comparedto placebo over a 3-year period. All 3 agents should be discussed(including risks and benefits) withwomen aged 35 years of older withouta personal history of breast cancerwho are at increased risk of developing invasive breast cancer, based onrisk factors such as the woman’s age,race, and medical and reproductivehistory.Exemestane is not approved by FDAfor breast cancer prevention, howeverthe ASCO guideline panel made thenew recommendation based on theNews Capsules continued on page 247FORMULARY ISSN 1082-801X(print), ISSN 1938-1166 (digital) is published monthly, by AdvanstarCommunications, Inc, 131 W. First St., Duluth, MN 55802-2065. 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If you do not want AdvanstarCommunications Inc. to make your contact information available to third parties for marketing purposes,simply call toll-free 866-529-2922 between the hours of 7:30 a.m. and 5 p.m. CST and a customerservice representative will assist you in removing your name from Advanstar’s lists. Outside the U.S.,please phone 218-740-6477.FORMULARY does not verify any claims or other information appearing in any of the advertisementscontained in the publication, and cannot take responsibility for any losses or other damages incurred byreaders in reliance of such content. FORMULARY welcomes unsolicited articles, manuscripts, photographs, illustrations and other materials but cannot be held responsible for their safekeeping or return.Library Access Libraries offer online access to current and back issues of FORMULARY through theEBSCO host databases. To subscribe, call toll-free 888-527-7008. 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Your Editorial BoardClinical EditorDavid Calabrese, RPh, MHPVP & Chief Pharmacy OfficerCatamaranWorcester, MassachusettsClinical Assistant ProfessorNortheastern University Bouvé Collegeof Health Sciences School of PharmacyBoston, [email protected] S.S. Chow,PharmDProfessor of Pharmacy Practice Director,Center for Advancement of Drug Researchand Evaluation College of PharmacyWestern University of Health SciencesPomona, CaliforniaCraig I. Coleman,PharmDAssociate Professor of Pharmacy PracticeUniversity of ConnecticutSchool of PharmacyStorrs, ConnecticutDirectorPharmacoeconomics and OutcomesStudies Group Hartford HospitalHartford, ConnecticutVicki S. Crane,MBA, FASHP, RPhVice PresidentClinical Support Services ParklandHealth and Hospital SystemDallas, TexasAbimbola Farinde,PharmD, MS,FASCP, FACAClinical Staff PharmacistClear Lake Regional Medical CenterWebster, TexasAdjunct FacultyColumbia Southern UniversityOrange Beach, AlabamaGeorge E. MacKinnon III, Domenic A. Sica, MDProfessor of Medicine andPhD, RPh, FASHPPharmacology ChairmanFounding Dean and ProfessorCollege of PharmacyRoosevelt UniversitySchaumburg, IllinoisRobert A. Quercia,MS, RPhRusty Hailey, PharmD,DPh, MBA, FAMPMedical EditorUniversity of Connecticut/HartfordHospital Evidence-based Practice CenterHartford, ConnecticutAdjunct Associate ProfessorUniversity of ConnecticutSchool of PharmacyStorrs, ConnecticutSVP and Presidentof Pharmaceutical OperationsHealthSpring, Inc.Nashville, TennesseeMichele B. Kaufman,PharmDPresidentPRN Communications, IncNew York, New YorkClinical PharmacistNew York Downtown HospitalNew York, New YorkAdjunct Assistant Professor (Pharmacy)Touro College of PharmacyNew York, New YorkContentPublishing & Sales(800) 225-456924950 Country Club BlvdSuite 200,North Olmsted, OH ECUTIVE VICE PRESIDENTGeorgiann DeCenzo(440) [email protected], GROUP PUBLISHERKen SylviaCONTENT CHANNEL DIRECTORJulie Miller(732) [email protected](440) [email protected] PUBLISHERMike WeissBUSINESS DIRECTOR, EMEDIADon Berman(212) [email protected], SALES DATAGail Kaye(732) [email protected] SUPPORTHannah Curis(732) [email protected](732) [email protected] SERVICESNATIONAL ACCOUNT MANAGERSharon AmesDIGITAL & INTERACTIVE CONTENTMANAGERBrandon Glenn(732) [email protected], ext. 121/[email protected] US, UK, direct dial:281-419-5725. Ext. 121NATIONAL ACCOUNT MANAGERPhil MolinaroLIST ACCOUNT EXECUTIVETamara Phillips(732) [email protected](440) [email protected](440) [email protected] MANAGER,CLASSIFIED/DISPLAY ADVERTISINGDarlene BalzanoPERMISSIONSMaureen CannonCONTENT COORDINATORMiranda Hester(440) [email protected] ART DIRECTORRob McGarrACCOUNT MANAGER,RECRUITMENT ADVERTISINGJacqueline Moran(440) [email protected](440) [email protected] PRODUCTION MANAGERKaren Lenzen(218) [email protected] 2013 Vol. 48 FormularyJournal.comAssociate ProfessorDepartment of Medicine,Section of Clinical PharmacologyUniversity of Missouri—Kansas City (UMKC)Kansas City, MissouriAssistant DirectorPharmacy Warm Springs Health andWellness CenterWarm Springs, Oregon(440) [email protected] SPECIALISTJulia BrownJames M. Wooten,PharmDLinda Schr