RTU Presentation - Sales Meeting June 2014

Leapfrogging into the injectables drug market; The case and pharmacoeconomics of ready-to-use (RTU) drugsJames G. BoudreauKelowna Sales Meeting June 10, 2014

This presentation represents my opinions of how we could leapfrog into the Canadian injectables drug market at this time. I have borrowed liberally from many sources to make my case and they have been referenced. The references are principally US and European based. There is very little Canadian literature, on the Canadian injectables market.

Si vous voulez poser des questions en franais, je ferais de mon mieux pour vous respondre.19/5/2014

FACTSMedication errors kill 7,000 people each year in the United StatesTo err is human, 1999Intravenous medication errors are nearly 3 times as likely to cause harm or death compared with other drugs routes (3% vs. 1.2%)Am J Health-Syst Pharm 2008;65:2367-79The risk is related to the complexity of the process and is froth with potential errors at every step

Risk = probability x consequences

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First, the facts.9/5/20142

Intravenous medication: a complex process


It is a complex process and Ill focus on the 3rd step of a 12 step process.Chances are that some of you may not know the well-known 5 rights of medication administration.1. Right patient2. Right medication3. Right dose4. Right route5. Right time

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Intravenous medication: errors at each stage


The 3rd step accounts for an average of 31% of all the errors in the 12 step process.9/5/20144

Preparation errorsSimulation study5 September 2014Kelowna Sales Meeting5

Mean rate: 6.5% (n=28)

Garnerin Ph, Eur J Clin Pharmacol 2007;63:769

That is not to say that errors dont occur in the other steps. In this simulation study, there was a 20% quantity error rate; 28% selection error and a 52% dilution error rate. 59/5/2014

Preparation errorsReal-life studyUnused syringes in anesthesiology> 10%: 29% > 50%: 8% > 100%: 4%


Stucki C, HUG, 2009

These are actual unused syringes from anesthesiology showing more than 50% of the unused syringes were under or over filled more than 8%9/5/20146

Calculation errors5 September 2014Kelowna Sales Meeting7

Nurses26.7% (n=30)

Anesthesiologists10.4% (n=28)

Garnerin Ph, Eur J Clin Pharmacol 2007;63:769

Calculation errors9/5/20147

Microbial contamination5 September 2014Kelowna Sales Meeting8

Syringes contaminationIntensive care units in 6 hospitals (A-F) Pharmacy aseptic unit (Ph(A)) Care Med 2002;30Van Garfhorst J, Crit :833-6

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Houston, weve got a problem!5 September 2014Kelowna Sales Meeting9

Houston, weve got a problem.9/5/20149

Canadian approach to safety Standardizing injectable drug dilutions and labelling


Ready-to-use (RTU) preparations

From the industry

From the hospital pharmacy

Production Plant (GMP) Outsourcing (Mixing/Compounding)

Aseptic Preparation (Batching/Patient specific)

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Ready-to-use (RTU) preparationsFrom the industryReady-to-useClindamycin 50 mL bag (Sandoz)600mg & 900mg Potassium Chloride (KCl) bag (Baxter)500 & 1000 mLCefazolin 100g bag (PPC)2 litersHeparin bag (B Braun)250 & 500 mL5 September 2014Kelowna Sales Meeting11

OutsourcingPre-filled syringesReconstitute powder vials for:Bags, syringes, intermate, pump cassettes, etc.Prepare batch and/or patient specific intravenous drugs

Hydromorphone 2mg/mL 10x1mL annual volume 4,272,600 vials/ampoules $0.89Dimenhydrinate 50mg/mL 10x1mL annual volume 2,528,770 ampoulesMORPHINE SO4 Inj 2mg/mL 10x1mLA - annual volume 1,069,460 ampoules9/5/201411

Ready-to-use (RTU) preparationsFrom the hospital pharmacyCollection of customer needsinterested clinical areas list of potential drugsRisk assessment priority list(probability of occurrence x consequences)Feasibility studyStability assessmentStarting batch productionResearch industrial partnership


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Ready-to-use (RTU) preparationsWhich is safer?From the industryGood manufacturing practices (GMP)Cleanrooms, laminar flow hoods, operator qualificationDocumentation (standardized production protocols)Working process (validation and informatics)Quality control: standard operating procedures (SOP)Traceability (whole process)From the hospital pharmacyLack of qualified personnel, room, funds, and timeShorter shelf life due to drug stability validation and testingProduction protocols and procedures (chemical)Computer-assisted production management (chemical)Clean environment (microbiological)Specifically trained operators (chemical, microbiological)


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5 September 2014Kelowna Sales Meeting14Operator ID password, facial recognition, fingerprintGravimetric weight selection dosing by weight vs. volumeMaterial ID barcode, photo label identificationTraceability metrics softwareComputer-assisted production

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PharmacoeconomicsHospital start-up costs for ready-to-use syringesInvestment costsCleanroom Class C (ISO 7) (20 m2 x $12,000/m2) $240,000 Filling machine Baxter Intellifill $600,000 i.v.STATION $700,000Total (depending on filling system) $940,0005 year amortization $188,000/year plus5 year amortization w/o cleanroom $140,000/year plus5 September 2014Kelowna Sales Meeting15

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PharmacoeconomicsHospital start-up costs for ready-to-use syringesDevelopment costs (stability study)Development and validation of a quantitative stability-indicating analytical methodStability studies

Total cost$14,800Cost / syringe$0.59 (5,000 syringes/year over 5 years)


14,800/5,000/5 = $0.59Keep in mind the numbers highlighted in blue

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PharmacoeconomicsHospital preparation costs of ready-to-use syringesProduction costs ($) (Phenylephrine 1mg conc./1mL size)Batch size 1,000 2,000 NurseVial unit price (1mL) $1.23 $1.23 $1.23Hood materials $1.18 $1.18Labour $1.48 $1.48 *$5.00Quality control $0.20 $0.10Total $4.09 $3.99 $6.23

5 September 2014Kelowna Sales Meeting17??* 5 minutes/syringe (Hecq JD, Ann Pharm Franaises 2011;69:30-7)

Pharmacy Technicans salary average $30 an hour and they take an average of 3 minutes to compound a liquid.Registered nurses salary average $60 an hour and they take an average of 5 minutes to compound a liquid.9/5/201417

PharmacoeconomicsHospital benefits of ready-to-use syringes5 September 2014Kelowna Sales Meeting18Risk AvoidancePre-filled Phenylephrine syringes produced 400,000/yearError Rate 5% 20,000/yearRatio errors: serious ADE$1,00,000/yearLeape L, JAMA 1999;281:267Cost-savingSyringes discarded in anaesthesiology50%

Weinger MB, J Clin Anesth 2001;13:491-7 $13.50/per syringe

4,685 Euros*1.48= $6,9349/5/201418

PharmacoeconomicsBottom line5 September 2014Cost/syringe ($) (based on 400,000/year) Pharmacy RTUWardInvestment $4.70Development $0.59Preparation $4.09$6.23Risk management (safety) ??Cost-saving (waste) ??Total (first 5 years) $9.38$6.23

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5 years

Slide 15 - $940,000 / 5 years / 400,000 = $4.70Slide 16 - $14,800 / 5,000 / 5 = $0.59Slide 17 - $1.23 + $1.18 + $1.48 + $0.20 = $4.09

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Innovations for safetyOptions5 September 2014Kelowna Sales Meeting20

RTU syringes/bags(CIVA)

Robotized distributionAutomated dispensing

Electronic prescription and patient record

Bedside scanningComputerization Automation Robotisation Industrialisation

Other options are available but expensive and labor intensive9/5/201420

ConclusionThe preparation of drug injectables in hospital units is not reliable

Ready-to-use (RTU) drugs improves patient safety by changing the paradigm

A high quality assurance system (GMP) is essential to ensure patient and worker safety.

Quality is paramount in a hospital setting as it will save time, money and ultimatelylives!


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Documents

RTU Presentation - Sales Meeting June 2014