Hot Topics in Pharmacy Hot Topics in Pharmacy Purchasing:Purchasing:

Regulatory Requirements, Regulatory Requirements, New Drugs, and GS1 New Drugs, and GS1

InitiativeInitiative

Lyle Matthews, Pharm.D, MAMLyle Matthews, Pharm.D, MAM

Director, Pharmacy ServicesDirector, Pharmacy Services

Eisenhower Medical CenterEisenhower Medical Center

GoalsGoals

Describe the three most Describe the three most challenging regulatory challenging regulatory requirements of regulatory requirements of regulatory agencies and State Boards of agencies and State Boards of Pharmacy involving Pharmacy Pharmacy involving Pharmacy Purchasing Professionals today.Purchasing Professionals today.

Goals (cont.)Goals (cont.)

List the three most interesting new List the three most interesting new medications coming in late 2011 and medications coming in late 2011 and 2012.2012.

Describe what the GS1 or Serial Describe what the GS1 or Serial NDC number initiative is and what it NDC number initiative is and what it means to Pharmacy Purchasing means to Pharmacy Purchasing ProfessionalsProfessionals

DisclaimersDisclaimers

One Director’s Thoughts (Mine)One Director’s Thoughts (Mine)

Each Organization is DifferentEach Organization is Different

GeneralGeneral Ideas And Philosophies Ideas And Philosophies

Goal is to present concepts that Goal is to present concepts that can be related to your individual can be related to your individual health systemshealth systems

Regulatory Challenges Facing Regulatory Challenges Facing Pharmacy Purchasing Pharmacy Purchasing

ProfessionalsProfessionals

What are the Issues?What are the Issues?Who is responsible for them?Who is responsible for them?How do we comply?How do we comply?

Without losing our mindsWithout losing our mindsWithout losing our friendsWithout losing our friends

Regulatory AgenciesRegulatory Agencies

Joint Commission on Accreditation of Joint Commission on Accreditation of Healthcare OrganizationsHealthcare Organizations

Centers for Medicare & Medicaid Centers for Medicare & Medicaid ServicesServices

State Boards of PharmacyState Boards of Pharmacy

State Departments of Public HealthState Departments of Public Health

Drug Enforcement AdministrationDrug Enforcement Administration

Food and Drug AdministrationFood and Drug Administration

What are the Regulatory Issues What are the Regulatory Issues Involving Medications?Involving Medications?

OrderingOrdering

ReceivingReceiving

DeliveryDelivery

StorageStorage

SecuritySecurity

AccessAccess

ControlControl

MonitoringMonitoring

Record Record RetentionRetention

Ordering and ReceivingOrdering and Receiving

Who can Order?Who can Order?

Do you Reconcile Receipt?Do you Reconcile Receipt?Controlled SubstancesControlled Substances

Are There Any Openings in Are There Any Openings in System?System?

DeliveryDelivery

Licensed Personnel?Licensed Personnel?

Volunteers or Transport Staff?Volunteers or Transport Staff?

OnsiteOnsite

OffsiteOffsiteAny process for security and control?Any process for security and control?

ReconciliationReconciliation

StorageStorage

Refrigerate or not?Refrigerate or not?Monitoring of Temps.Monitoring of Temps.Vaccines, Vaccines, VaccinesVaccines, Vaccines, VaccinesSound Alike - Look Alike (SALA)Sound Alike - Look Alike (SALA)

Functional SeparationFunctional Separation

Floor StockFloor StockCrash Carts & Emergency BoxesCrash Carts & Emergency Boxes

SecuritySecurity

Medication RoomsMedication Rooms

Automated Dispensing Cabinets Automated Dispensing Cabinets (ADC’s)(ADC’s)

Lockable CabinetsLockable Cabinets

Lockable RefrigeratorsLockable Refrigerators

Controlled SubstancesControlled Substances

AccessAccess

Who has access to our Meds?Who has access to our Meds? Seemingly EveryoneSeemingly Everyone

Who controls who has Access to:Who controls who has Access to: Medication Rooms?Medication Rooms?

ADC’s?ADC’s?

Controlled Substance Room?Controlled Substance Room?

ControlControl

Who can change things without Who can change things without you knowing?you knowing?

Hospital FormularyHospital Formulary

Automated Dispensing CabinetsAutomated Dispensing Cabinets–PAR levelsPAR levels

–LocationsLocations

Answer to Question: Answer to Question: Who Can Change Things? Who Can Change Things?

Seemingly EveryoneSeemingly Everyone

Seemingly ConstantlySeemingly Constantly

Seemingly ForeverSeemingly Forever

MonitoringMonitoring

Who is watching?Who is watching?

Is anything Missing?Is anything Missing?

Has Anything Changed?Has Anything Changed?

Controlled Substance Ordering Controlled Substance Ordering PatternsPatterns

Record RetentionRecord Retention

RecallsRecallsTrailer TheftTrailer TheftInvoices (3 years on site?)Invoices (3 years on site?)Controlled SubstancesControlled Substances

InvoicesInvoices222 Forms222 FormsCSOSCSOS

Who is Responsible For Helping Who is Responsible For Helping Control Things?Control Things?

Director of Pharmacy?Director of Pharmacy?Operations Manager?Operations Manager?Technician Supervisor?Technician Supervisor?Nursing Staff?Nursing Staff?O.R. and E.D. Staff?O.R. and E.D. Staff?EveryoneEveryone

Sound Familiar?Sound Familiar?

““I don’t know how the vaccines I don’t know how the vaccines are stored, ask the Buyer.”are stored, ask the Buyer.”

““I don’t know what temperature I don’t know what temperature the refrigerators are supposed to the refrigerators are supposed to be kept, ask the Buyer.”be kept, ask the Buyer.”

““I don’t know who has access to I don’t know who has access to the Automated Dispensing the Automated Dispensing Cabinets, ask the Buyer.”Cabinets, ask the Buyer.”

How Do We Control These How Do We Control These ChallengesChallenges

Communicate With The Communicate With The Pharmacy Management TeamPharmacy Management TeamEnsure They Realize Ensure They Realize YouYou Have to Have to Know What is HappeningKnow What is HappeningEnsure You are Included In all Ensure You are Included In all DiscussionsDiscussions

P&T Committee Membership?P&T Committee Membership?

Regulatory SummaryRegulatory Summary

Everyone is responsible for Everyone is responsible for Regulatory ComplianceRegulatory Compliance

Everyone Has Their hands in Our Everyone Has Their hands in Our Meds – Try to control them.Meds – Try to control them.

Communicate and Solve Communicate and Solve Problems Together As a TeamProblems Together As a Team

Joint Commission Survey Joint Commission Survey Aug. 9-12, 2011 Aug. 9-12, 2011

Magnesium SulfateMagnesium SulfateRecallsRecalls– Notification of Nursing/Medical StaffsNotification of Nursing/Medical Staffs

Expired and Recalled Medication Expired and Recalled Medication Storage – SegregationStorage – SegregationAre you a County/State Cache Are you a County/State Cache Site?Site?

New Medications forNew Medications for2011 and 20122011 and 2012

Some have Financial ImpactSome have Financial Impact

Some have Clinical ImpactSome have Clinical Impact

Some will just have Psychological Some will just have Psychological Impact on Us and Make Our Lives Impact on Us and Make Our Lives DifficultDifficult

PradaxaPradaxa(dabigatran etexilate mesylate)(dabigatran etexilate mesylate)

Highly ControversialHighly Controversial

Expensive compared to CoumadinExpensive compared to Coumadin

BID dosing (vs. daily Coumadin)BID dosing (vs. daily Coumadin)

Leap of faith for patients who are Leap of faith for patients who are used to having INR’s drawnused to having INR’s drawn

Reports of BleedingReports of Bleeding

EffientEffient(prasugrel)(prasugrel)

Oral Antiplatelet Medication for Oral Antiplatelet Medication for patients following angioplastypatients following angioplasty

No proven reversal agentNo proven reversal agent

Cardiac Surgeons are largely Cardiac Surgeons are largely opposed and/or skepticalopposed and/or skeptical

ProvengeProvenge(Sipuleucel-T)(Sipuleucel-T)

For Advanced Prostate CancerFor Advanced Prostate Cancer

FDA Approved April 2010FDA Approved April 2010

Very complicated administrationVery complicated administration

$93,000 for course of Treatment$93,000 for course of Treatment

Controversial – extends life by Controversial – extends life by approximately 4.5 monthsapproximately 4.5 months

All sorts of problems for DendreonAll sorts of problems for Dendreon

XareltoXarelto(rivaroxaban)(rivaroxaban)

DVT prophylaxis in knee and hip DVT prophylaxis in knee and hip replacement patientsreplacement patientsFDA Approved July 1, 2011FDA Approved July 1, 2011Marketed against Lovenox/CoumadinMarketed against Lovenox/CoumadinTaken orally (10mg daily)Taken orally (10mg daily)Applying for indication for A-fib pts.Applying for indication for A-fib pts.Available in Europe since 2008Available in Europe since 2008

Arcapta NeohalerArcapta Neohaler(indacaterol)(indacaterol)

Long acting beta-2 adrenergic Long acting beta-2 adrenergic agonist for COPD patientsagonist for COPD patients

75 mcg capsule daily using the 75 mcg capsule daily using the NeohalerNeohaler

Not for asthma patientsNot for asthma patients

Will be available in 1Will be available in 1stst quarter of quarter of 20122012

BrilintaBrilinta(ticagrelor)(ticagrelor)

FDA Approved July 2011FDA Approved July 2011

$7.24 per day (20% more than $7.24 per day (20% more than Plavix (clopidogrel)Plavix (clopidogrel)

Shown superior to Plavix when Shown superior to Plavix when combined with low dose aspirin to combined with low dose aspirin to prevent heart attacks and strokesprevent heart attacks and strokes

clopidogrel generic in May 2012.clopidogrel generic in May 2012.

YervoyYervoy(ipilimumab)(ipilimumab)

Unresectable or Metastatic Unresectable or Metastatic MelanomaMelanoma

Dose is 3mg/kg IV over 90 min. Dose is 3mg/kg IV over 90 min. every 3 weeks x 4 dosesevery 3 weeks x 4 doses

50 mg and 200 mg vials50 mg and 200 mg vials

Extends life avg. of 4 monthsExtends life avg. of 4 months

$120,000 for 4 dose course$120,000 for 4 dose course

VictozaVictoza(liraglutide)(liraglutide)

For Type 2 DiabetesFor Type 2 Diabetes

GLP-1 analog Targeting Pancreatic GLP-1 analog Targeting Pancreatic beta cellsbeta cells

Increases Insulin Secretion and Increases Insulin Secretion and move sugar into cellsmove sugar into cells

Watch for hints of weight loss help Watch for hints of weight loss help

DificidDificid(fidaxomicin)(fidaxomicin)

Already ReleasedAlready ReleasedFor Clostridium dificile associated For Clostridium dificile associated diarrheadiarrheaOne 200mg tablet BID x 10 daysOne 200mg tablet BID x 10 days$140 per tablet$140 per tabletMore expensive that oral VancoMore expensive that oral Vanco–(less that IV Vanco given orally)(less that IV Vanco given orally)

AvastinAvastin(bevacizumab)(bevacizumab)

Not newNot new

Very Expensive and Very PopularVery Expensive and Very Popular

Controversial indication for Breast Controversial indication for Breast CancerCancer

Keep watching – Changes are Keep watching – Changes are ComingComing

Expiring Patents in 2011Expiring Patents in 2011

LipitorLipitor

ZyprexaZyprexa

LevaquinLevaquin

ConcertaConcerta

ProtonixProtonix

Total sales of $10 Billion in 2010Total sales of $10 Billion in 2010

LipitorLipitor(atorvastatin)(atorvastatin)

Patent expired June 2011Patent expired June 2011Ranbaxy Generic Atorvastatin Ranbaxy Generic Atorvastatin available Nov. 2011available Nov. 2011Significant potential cost savings, Significant potential cost savings, but probably further down the but probably further down the roadroadGuess what Pfizer has proposed?Guess what Pfizer has proposed?

GS1 InitiativeGS1 Initiative

GS1 or Serial NDC Number GS1 or Serial NDC Number ProjectProject

Guidance for Securing the Drug Guidance for Securing the Drug Supply Chain – Standardized Supply Chain – Standardized Numerical Identification for Numerical Identification for Prescription Drug PackagesPrescription Drug Packages

Who are GS1?Who are GS1?

““GS1 is a global organization GS1 is a global organization dedicated to the design and dedicated to the design and implementation of global implementation of global standards and solutions to standards and solutions to improve efficiency and visibility in improve efficiency and visibility in supply and demand chains.”supply and demand chains.”

–From GS1 letter to the FDA April, 2009From GS1 letter to the FDA April, 2009

What does it mean to us?What does it mean to us?

Their goal is to standardize NDC Their goal is to standardize NDC standards globallystandards globally

This would potentially enhance This would potentially enhance supply chain tracking and tracingsupply chain tracking and tracing

Could embed product specific Could embed product specific informationinformation

Thank you for having me again.Thank you for having me again.

Best wishes to the NPPA and all Best wishes to the NPPA and all of the Pharmacy Purchasing of the Pharmacy Purchasing

ProfessionalsProfessionals

Questions?Questions?