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Sources of DoD Information. Libby Hearin, PharmD Harsha Mistry, PharmD. Objectives. Describe sources of Uniform Formulary and clinical information that local MTF personnel can use for formulary decision making Focusing on the following tools: TRICARE pharmacy webpages PEC website RxNET
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Sources of DoD Information Libby Hearin, PharmD Harsha Mistry, PharmD
Objectives • Describe sources of Uniform Formulary and clinical information that local MTF personnel can use for formulary decision making • Focusing on the following tools: • TRICARE pharmacy webpages • PEC website • RxNET • Formulary search tool
Knowing Our Audience • Clinical background • Years within the military system • Participated in P&T Committee meetings • Exposure to the Uniform Formulary and related resources • Your favorite resource
Overview • Describe DoD Uniform Formulary (UF) • What is it? • Answer DoD UF specific questions • Where do I find the answers? • Prepare for local MTF formulary decisions • How can I prepare a presentation with pertinent information? • Stay current with new drugs and UF information
DoD Uniform Formulary (UF)Terminology • BCF vs. ECF • www.pec.ha.osd.mil • BCF (basic core formulary) • list of medications required to be on formulary at all full-service Military Treatment Facilities (MTFs) • ECF (extended core formulary) • Therapeutic classes that are used to support more specialized scopes of practice than those on the BCF. • MTFs may choose whether or not to include an ECF therapeutic class on formulary. • If an MTF chooses to have an ECF therapeutic class on formulary, it must have ALL ECF medications in that class on formulary.
DoD UF and P&T CommitteeKey points • The DoD P&T Committee makes recommendations regarding the formulary status of medications on the BCF, ECF, and UF to the Director, TRICARE Management Activity (TMA). • The Director, TMA, makes final decisions after considering comments from the Beneficiary Advisory Panel (BAP). • The minutes are available approximately 2-3 months after the meeting.
DoD P&T Committee Minute Websites • P&T Committee minutes & future meeting information • www.pec.ha.osd.mil • www.tricare.mil/pharmacy • P&T Committee cumulative minutes • www.dodrxnet.org • BAP handouts • www.tricare.mil/pharmacy/BAP/default.htm
Objectives • Part 1: Understand the question • Rumor or Truth? • Part 2: Evaluate the question • Related to UF or local formulary decisions • Part 3: Answer the question • PEC drug class written reviews • Other evidence-based medicine reviews • Other drug literature websites
Part 1: Understand the QuestionScenario 1 • Dr Snow asks the technician at the MTF pharmacy window: Why can’t my patient get her pregabalin? • Understand what the question is asking… • Does the medication have formulary restrictions? • Are there supply or distribution issues ?
Part 2: Evaluate the QuestionDoes this medication have formulary restrictions? Fast facts: • TRICARE formulary search tool: www.tricareformularysearch.org • TRICARE Pharmacy pages www.tricare.mil/pharmacy
Part 2: Evaluate the Questionwww.tricareformularysearch.org pregabalin
Part 2: Evaluate the QuestionDoes this medication have formulary restrictions? Effective date pregabalin
Part 3: Answer the QuestionWhy can’t my patient get pregabalin at the local MTF pharmacy? Short Answer: • MTF pharmacies do not carry non-formulary medications, such as pregabalin. Long Answer: • MTF pharmacies do not carry non-formulary medications, but if the patient meets the medical necessity criteria, the patient may qualify to receive the medication at the MTF.
Follow-Up Questions: What are the formulary alternatives Fast Facts • TRICARE formulary search tool: www.tricareformularysearch.org • RxNET: Formulary Management document • www.dodrxnet.org
Formulary alternativeswww.tricareformularysearch.org pregabalin Formulary alternatives
What are the medical necessity criteria for pregabalin? Medical necessity criteria and forms • RxNET: Word version • www.dodrxnet.org • TRICARE pharmacy pages: PDF version • www.tricare.mil/pharmacy
Medical Necessity Criteria and Formswww.tricare.mil/pharmacy Medical Necessity PDF form Medical Necessity Criteria
Follow-Up: TMOP & Retail Network Information What if my patient wants to use TMOP or a network retail pharmacy? • TRICARE formulary search tool: • Drug availability information • Copay ($3, $9, or $22) • Generic equivalents • Alternatives and their respective copays • Restrictions: Quantity Limits (QL), Prior Authorizations (PAs)
TMOP & Retail Network Informationwww.tricareformularysearch.org Mail Order Retail
Part 1: Understand the QuestionScenario 2 Your P&T Chair asks you: What are we going to do with atorvastatin? • Understand what the question is asking: • What is atorvastatin’s UF status? • Is atorvastatin a BCF agent? • What formulary options do local MTFs have in regarding atorvastatin?
Part 2: Evaluate the Question • What was the final UF decision for the statin drug class? • P&T minutes • TRICARE Pharmacy pages • RxNET • Formulary Management Document • RxNET • Which products are local MTFs required to carry? • BCF/ECF status • Formulary Management Document: RxNET • Complete BCF/ECF listing with changes: PEC website • Do local MTFs have additional guidance? • Formulary Management Document: RxNET
Part 3: Answer the QuestionWhat are we going to do with atorvastatin? • Atorvastatin is Formulary Brand (Tier 2) on the UF • BCF agents • Simvastatin • Pravastatin • Niacin extended release • Atorvastatin is NOT a BCF agent • Local MTFs can make local formulary decisions for atorvastatin • Bottom Line: Our local MTF P&T Committee needs to make this decision
How to prepare for a local MTF P&T meetingPieces of the puzzle • Know your topic • Drug class or a new drug • Cite reputable literature sources • Evidence based medicine (EBM) reviews • Package the right information • Know your audience • Present a recommendation summary • What is the bottom line?
How to prepare for a local MTF P&T meetingKnow your topic • Has the DoD P&T committee reviewed the drug class? • Table of Uniform Formulary decisions: www.pec.ha.osd.mil/MTF/UF_Info.htm • Future drug class evaluations: www.pec.ha.osd.mil/PT_Committee.htm • RXnet: Formulary management documents www.dodrxnet.org • If possible hold off on a decision if the DoD P&T committee will be reviewing the drug class in the near future
How to prepare for a local MTF P&T meeting Cite reputable literature sources • National EBM Resources • Oregon Evidence- based Practice Center Drug Effectiveness Review Project (DERP) • www.ohsu.edu/drugeffectiveness/reports/final.cfm • Written reviews, (caveat: narrow focus) • Veterans Affair PBM (VA-PBM) • www.pbm.va.gov/default.aspx • Written reviews, new drug monographs (caveat: unique patient population & bottom line) • Cochrane Database (OVID) • PEC written reviews @ RxNET • www.dodrxnet.org/
How to prepare for a local MTF P&T meeting Cite reputable literature sources • International EBM resources • UK: National Institute for Clinical Reviews (NICE) • www.nice.org.uk • UK: Trip database • www.tripdatabase.com/index.html • UK: Bandolier • www.jr2.ox.ac.uk/bandolier • Canada: Canadian Agency for Drugs and Technology in Health • www.cadth.ca
How to prepare for a local MTF P&T meeting Know your audience • Health professionals • Pharmacology: therapeutic class, mechanism of action • Efficacy measures: report meta-analyses, DB PC trials, head to head trials if available • Safety: list common adverse events, special populations, potential drug-drug interactions, overall benefit vs risk ratio, and tolerability (drug discontinuation due to ADRs) • Other issues: administration, availability, distribution & packaging, dosage forms, patents, etc. • Conclusion • Efficacy summary • Safety summary • Overall conclusion
How to prepare for a local MTF P&T meeting Know your audience • Health Care Administrators • Utilization of drugs • Possible market shifts to other drugs • Possible shifts to another point of service • Supply mechanism • Cost issues • Current therapies vs. “new drug” (remember cost/day of therapy) • Formulary restriction such as quantity limits, prior authorization, medical necessity issues
How to prepare for a local MTF P&T meeting Recommendation summary • What is the bottom-line? • Very difficult to determine at times • Analyze clinical effectiveness in conjunction with cost effectiveness • The system (MTF personnel) must be able to handle the decision • Summarize ways to help the decision • FAQ sheets • Algorithms • Pre-written order sheets • Formulary management document
How to stay current:FDA websites at www.fda.gov.cder Center for Drug Evaluation and Research • Drugs @ FDA section • Package insert, approval letter • Detailed medical, chemistry, statistical reviews often available • Generic drugs • www.fda.gov/cder/ogd/approvals/ • www.fda.gov/cder/drug/shortages/default.htm • Safety warnings • www.fda.gov/medwatch • Dear Doctor letters; reverse chronological listing of safety alerts; changes in package inserts related to safety issues
How to stay current:Auto-updates Sign up for auto-updates for: • DoD UF specific information: • RxNET www.dodrxnet.org • DoD P&T minutes page www.tricare.mil/pharmacy • Clinical information: • New drug approvals www.fda.gov/cder/cdernew/listserv.html
Where to find already prepared drug monographs • VA PBM (Pharmacy Benefits Management) • www.pbm.va.gov/default.aspx • VA’s equivalent of the PEC • Monographs, criteria for use are on-line • AMCP dossier from individual companies • Pharmacy Journals (AJHP, Pharmacotherapy) • Still must critically analyze!
Newly Approved Drugs –Free Monthly Journals (peer-reviewed) • Formulary Journal - (www.formularyjournal.com) • New drug monographs; class reviews, news alerts, drugs in the pipeline • P&T Journal (www.ptcommunity.com/ptjournal/journalview.cfm) • similar info as the Formulary Journal; health policy • Hospital Pharmacy Journal (www.hospitalpharmacyjournal.com) • Inpatient focused; lots of JCAHO tips • “Current FDA-related drug info”: Column on new drugs, drugs in the pipeline, drugs with new indications • Free journals, but need to fill out card saying you are part of a P&T Committee
Our Bottom Line is the Big Picture • Resources with pre-packaged information are available to help you with your local formulary decision-making process, daily questions, and personal growth • Our goal is to keep you well-informed regarding UF decisions and current clinical information • PEC Website • www.pec.ha.osd.mil