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Closed loop medication up to point-of-care scanning Dennis Even, IT Director, Pfizer Inc, US

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Page 1: Closed loop medication up to point-of-care scanning...35 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Errors per day detected by MedEye, by ability to fix Fixed with scanner Fixed with

Closed loop medication up to point-of-care scanning

Dennis Even, IT Director, Pfizer Inc, US

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© GS1 2019 2

Dennis EvenPfizer Inc., US

Iain Davidson Royal Cornwall

Hospitals NHS Trust

Michiel Duyvendak, St. Antonius Hospital

Sebastien Langlois-Berthelot

F. Hoffmann-La Roche Ltd

Ad DeebenTEVA

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Closed Loop Medication Up to Point-of-Care Scanning

Dennis Even, Director Digital & Technology, Pfizer Inc 26th of March 2019

GS1 Global Healthcare Conference - Noordwijk

Pfizer Global Supply – Manufacturing and Quality Solutions

Copyright @ Pfizer Inc. All rights reserved.

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4

Disclaimer: This presentation outlines a general technology direction. Pfizer Inc has no obligation to pursue any approaches outlined in this presentation or to develop or use any functionality mentioned in this presentation. The technology strategy and possible future developments are subject to change and may be changed at any time for any reason without notice.

The views and opinions expressed in this presentation and any related discussion(s) are solely those of the individual presenter(s) and may not express the views of and opinions of Pfizer Inc.

Copyright @ Pfizer Inc. All rights reserved.

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Agenda

The Basics: Coding & Systems

Inherent Challenges

US Story: Scanning at point of care

5Copyright @ Pfizer Inc. All rights reserved.

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6

The Basics

Increase patient safety /

decrease adverse drug

events (ADE) by introducing technology

Unit Dose Coding / Hospital Unit Dose (HUD)

Barcode Medication Administration (BCMA): Dispense / Bedside Scanning

GTIN

GTIN, Lot, Exp Date(Blister, Bottle, Tube,

Syringe, etc)

Linking / ensuring prescribed medication

is the provided medication

Aligned product drug codes is foundational

to overall success

Copyright @ Pfizer Inc. All rights reserved.

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7

Single Unit POC Scanning Process

Country / Product / presentation

GTINTool

GTIN Product Strength Primary pack

Country

xxxxx xxxxx xxxxx Blister xxxxx

xxxxx xxxxx xxxxx Bottle xxxxx

GTIN : 12345678901234

Artwork development process

Hospital

Approve AW + 2D code

12

Print + Label 35

4

GTIN

Copyright @ Pfizer Inc. All rights reserved.

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8

Inherent Challenges Challenges vary depending on environmental variables and the stages of change

Physical

Space

Container Types / Materials

Readability

People

Process / Requirements

Standardization

Adoption

End-User-Change-

Management

Technology

Master Data Alignment

System Change Management

Copyright @ Pfizer Inc. All rights reserved.

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US Story: Scanning at Point-of-Care• April 2004, FDA mandated barcodes on labels by 2006 1

– Predicted prevention of nearly 500,000 adverse events / transfusion errors over the 20 years (estimated cost savings of $93 billion) 2

• Pfizer started HUD coding in 2003– GTIN, Exp Date, Lot

• Emergency department BCMA implementation reduced medication administration errors by nearly 67%, and wrong dose errors by 90% 3

• Evidence of reliance in 2017 with disruption (GS1 UPC-A replaced by some manufacturers with the GS1 DataMatrix)

Annotations: 1. Food and Drug Administration: FDA issues barcode regulation; fact sheet. Washington, DC: 2004. Available at: http://www.fda.gov/oc/initiatives/barcode-sadr/fs-barcode.html.2. FDA to require bar coding of most pharmaceuticals by mid-2006. Am J Health Syst Pharm 2004;61(7):644–5.3. Research published by the Society for Academic Emergency Medicine (Bonkowski et al., 2013) 9

Copyright @ Pfizer Inc. All rights reserved.

http://www.fda.gov/oc/initiatives/barcode-sadr/fs-barcode.html
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US Story: Evolution

• Target all patient points of care• Electronic health records• Testing services• Payment services• Prescription claims• Reporting• Etc

10

Medicinal barcode scanning has grown to much more…BPOC – Barcode at point of care +++

Copyright @ Pfizer Inc. All rights reserved.

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In Summary

The Basics: Coding, Systems, & Data Alignment

Unit dose coding & scanning has shown value and more

Challenges will be met along the way

11Copyright @ Pfizer Inc. All rights reserved.

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12Copyright @ Pfizer Inc. All rights reserved.

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Medication SafetyCan Technologymake life better?

Dr. Michiel Duyvendak, Hospital Pharmacist, GS1 Congres 26-03-2019Antonius Hospital Sneek & Emmeloord Conflict of Interest: None

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The Essence of Health Care

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Typical Process

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Optical Strenght and Weakness

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Results of BCMA

Bates et al. JAMA 1995 E.Poon et al. NEJM 2010, Hassink et al. PW 2012

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Implementation >95% UDP BCMA is Slow

2003

2011

20132016

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Scanning on the Ward

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Patient Errors

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Recent Errors

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Sound alike

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High Risk

Unusable/Errornous Barcode

Protect from light/moist no unit dose pack

Issues

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Good Manufacturing Practice

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High risk medication (RTA)

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Antonius Sneek

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Workarounds and Errors

29

MAE No MAE Total OR (95% CI)

WA 271 (4.7%) 3362 (58.0%) 3633 (62.7%)

No WA 16 (0.3%) 2144 (37.0%) 2160 (37.3%)

Total 287 (5.0%) 5506 (95.0%) 5793 (100%)3.06 [ 2.49-3.78]

Veen v/d et al., 2017: https://doi.org/10.1093/jamia/ocx077

https://doi.org/10.1093/jamia/ocx077
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Medication Dispensing (Nursing)Home

31

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Questions?

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EU-directive

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Software only solutions to closed loop verification cannot detect or fix several categories of errors

34

Barcodes Medeye SoftwareMedEye Software

+ scanner LegendTabletsBaxtered

Extra pill in bag 0 1 2 Doesn't detect 0Pill missing from bag 0 1 2 Detects but can't fix 1Split pill error 0 1 2 Detects and fixes 2Stopped prescription 1 1 2New prescription 2 2 2Wrong patient 0 2 2

Not Baxtered

Extra pill given 0 0 2Too few pills given 0 0 2Pill needs to be split 1 1 2Stopped prescription 2 2 2New prescription 2 2 2

Non TabletsBarcoded

Wrong medication 1 1 1Stopped prescription 1 1 1Wrong dose 0 0 0

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Nurses can fix 100% of errors only if they use both software and hardware

35

0%10%20%30%40%50%60%70%80%90%

100%Errors per day detected by MedEye, by ability to fix

Fixed with scanner Fixed with SW“Fixed with scanner” counts errors of extra pills in multi-dose bags; “Fixed with SW” counts errors medication already verified, wrong patient,

extra pills in single-dose

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Medication Adherence

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Requests to legislators

On top of counterfeit measures:

Request mandatory • Single cell primary package• GTIN in barcode on all levels => also the primary package.• GTIN, Lot.nr en EXP. date on all levels and labels

•Request voluntarily• Labels in a more uniform lay-out

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Reduction errors and risk of preventable ADE’s

Baseline error rate varied between 5.8% and 25.3% if time errors were includedand between 1.6% and 27.3% when time errors were excluded. Most studies show a 30–50% reduction in medication administration errorsafter implementation of BCMA when time errors are excluded. However, implementation of BCMA does not result in a consistent reduction when time errors are included.

Morris et al found that BCMA reduced the risk of preventable ADEsby 47% and Poon et al showed a 50.8% reduction in potential ADEs.In this latter study the reduction in many of the potential ADEs couldbe attributed to improved medication administration documentation.

Effects of bar code-assisted medication administration (BCMA) on frequency, type and severity of medication administration errors: a review of the literature Jeroen Hassink,1 Mark Jansen,1 Pieter Helmons2 European Journal of Hospital Pharmacy 2012;19: 489–494

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Effects of bar code-assisted medication administration (BCMA) on frequency, type and severity of medication administration errors: a review of the literature Jeroen Hassink,1 Mark Jansen,1 Pieter Helmons2 European Journal of Hospital Pharmacy 2012;19: 489–494

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Effects of bar code-assisted medication administration (BCMA) on frequency, type and severity of medication administration errors: a review of the literature Jeroen Hassink,1 Mark Jansen,1 Pieter Helmons2 European Journal of Hospital Pharmacy 2012;19: 489–494

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Scannable dose.Ad Deeben

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Medisch Contact May 1984

Distribution medicines in nursing homes

Identification on unit level

Costs 3 cents per dose

EAV guarantees clear identification

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Development of the EAV packaging in time1984 EAV introduction, Printed(EAG suitable unit dose)

.

.

.

Not in the RA dossier:

2000 EAV JFK barcode•Scannable JFK code for identification and record in

electronic patient file.

1990 EAV JFK barcode Sticker•Scannable JFK code on stickers for paper patient

file.

2018 EAV GTIN barcode•Scannable 2D matrix code for identification and

record in electronic patient file.

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EAV NL (EAV = Unit Delivery Package)

The first EAV packaging was created in 1983

.

.

.

.

.

.

The first Teva customer: Haagse Ziekenhuizen

2015 EAV portfolio Teva NL >200 SKU

EAV packaging is expensive

Customer does not want to pay for it

Hospitals do not use the JFK code (do not scan JFK)

Conversion JFK to GTIN in 2019

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Solutions providers scannable dose

• Manufacturers– As a registered product EAV– As part of the label

• Repackers– CPO registered EAV– Re-label In assignment under the

responsibility of hospitals• Wholesale

– Re-label Not registered under the responsibility of hospitals

• Hospital automation– Various systems, method to code, re-label– Compounding products– EPD (patients dossier) File 007 GTIN

– Baxter packed per intake moment– UDP– Swisslog (http://www.medicalexpo.com/prod/swisslog/product-70236-666345.html)

– MedEye– Local solutions for compounding– etc.

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Current EAV creation process (+/- 5% market volume)

Ordering Bulk

Receiving bulk at CPO

Bulk entry in Oracle by planner

Inspection & release bulk byQA

Bulk Certificate by ERP / Copy CoA on the network by QA

Splitting bulk if more presentations

Purchase order CPO

Batch creation and bulk allocation

Batch documentation to CPO

Splitting bulk if more presentations CPO 1 batch

FG Receive at pre wholesale

Inspection & release by QA

Ready report by planning

Sampling pre wholesale

Serialization

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Apply a scannable code to the existing blister?Iss

ues t

hat a

rise

The space on the blister is limited

Reflection aluminiumWhite background for

readabilityPerforated blister

Symmetrical blister

Adjustment registration file

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Next steps, the future

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Medication administration, compliance and safety

49

Home situation

4. Informal, care support

3. Packed per intake moment,

Baxter scannable

2. Medication app support

1. Medicinesfrom the pack

Nursing home

5. Medication distribution system

6. Baxter, packed per intake moment

scannable

Hospital

7. Scannable dosebedside scanning

https://www.youtube.com/watch?v=kETBLIiW1bc reconciliatie

https://www.youtube.com/watch?v=kETBLIiW1bc
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Figure 4. Illustration ‘Closed loop Medication Management’. Adapted and acquired with permissionfrom: http://cstproject.ca/news/closed -loop-medication -management-safety-win Copyright 2014 , Clinical & Systems Transformation (CST).

Closed loop medication management system

200 SKU with JFK code available

3 Hospitals scan upon administration

Introduction GTIN in file 007 in 2017

Adjustment hospital systems to use file 007 in 2018

Conversion from JFK to GTIN

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Now there is a standardIs

ther

e co

ord

ina

tion

&

alig

nmen

tHospitals

Pharmaceutical companies

IT systems in Hospitals en Pharmacies

Data source pharma and GS1

EU countries

Willing to pay, can extra costs be charged?

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Disclaimer

This presentation includes certain information that Teva deemed fit to present at this time. This presentation includes a summary of the issues addressed herein, in specific context, and not the full information that Teva has on such matters, and it is not intended to supersede or replace the need to review public reports and statements published by Teva in accordance with applicable law or otherwise. In any event of discrepancy between the figures contained in this presentation and the figures contained in Teva's public reports, figures contained in public reports shall be deemed correct. This presentation and the accompanying remarks contain forward-looking statements, which express the current beliefs and expectations of management. Such statements involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products, including our ability to develop, manufacture, market and sell biopharmaceutical products, competition for our innovative products, especially COPAXONE® (including competition from innovative orally-administered alternatives, as well as from potential purported generic equivalents), competition for our generic products (including from other pharmaceutical companies and as a result of increased governmental pricing pressures), competition for our specialty pharmaceutical businesses, our ability to achieve expected results through our specialty, including innovative, R&D efforts, the effectiveness of our patents and other protections for innovative products, decreasing opportunities to obtain U.S. market exclusivity for significant new generic products, our ability to identify, consummate and successfully integrate acquisitions, the effects of increased leverage as a result of recent acquisitions, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our potential exposure to product liability claims to the extent not covered by insurance, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement, any failures to comply with complex Medicare and Medicaid reporting and payment obligations, governmental investigations into sales and marketing practices (particularly for our specialty pharmaceutical products), uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology-based products, adverse effects of political or economical instability, corruption, major hostilities or acts of terrorism on our significant worldwide operations, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, any failure to retain key personnel or to attract additional executive and managerial talent, the impact of continuing consolidation of our distributors and customers, variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities, the termination or expiration of governmental programs or tax benefits, environmental risks and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2013 and in our other filings with the U.S. Securities and Exchange Commission (“SEC”). Forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to update any forward-looking statements or other information contained in this presentation, whether as a result of new information, future events or otherwise. You are advised, however, to consult any additional disclosures we make in our reports to the SEC on Form 6-K.Teva owns or has the proprietary rights in the information contained in this presentation.

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GS1 Global Healthcare Conference 2019 Iain Davidson-Chief Pharmacist

BPharm. MRPharmS. MSc. FFCI.Royal Cornwall Hospitals NHS Trust

Advanced Medicines ManagementMedication Errors & the Role of

Bar-Code Scanning

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Mr White said the two boxes were “side by side on the shelf and have similar branding”.

Mr White claimed to have carried out the required checks under the pharmacy standard operation procedures.

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RESEARCH & EVALUATION

The Adoption of Barcode Scanning Technology in an

Acute NHS Hospital Pharmacy

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‘GSRN’ ‘GTIN’

‘GLN’

Barcode Enabled Dispensing

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RESULTS

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Safer Dispensing (P<0.001)Prevented Error Rates Reduction

Error type

Dispensing Error MonitoringPeriod 1

(barcode non mandatory)

Dispensing Error MonitoringPeriod 2

(barcode mandatory)Prevented Incidents Rate (%)

Prevented Incidents Rate (%)

Bar-code Insensitive Errors

Administrative 4 0.11 2 0.04Label directions 13 0.35 7 0.15

Total Bar-code Insensitive Errors 17 0.46 9 0.19

Barcode Sensitive Errors

Wrong patient 1 0.03 0Drug strength 5 0.13 0

Drug form 3 0.08 0Drug name 2 0.05 0Cost centre 1 0.03 0

Total Bar-code Sensitive Errors 12 0.32 0

Total Number of prevented Errors 29 9Number of non-stock items dispensed 3730 4667Prevented Error Rate (%) 0.78 0.19 (P <0.001)

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Next Steps

Integration of GS1 into other Steps in the Dispensing Process

& Barcode Medicines Administration

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Co-Codamol Tablets

ONE tablet to be taken FOUR times a day, when required for pain

Mr. Alex Krasnov 16-FEB-2018Lviv Hospital Pharmacy, Lviv Hospital, LVIV, LV Oblast

KEEP OUT OF REACH OF CHILDREN

60 tablets1

2

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Wider Application

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Barcode Medicines Administration

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Manufacturers Take Note!

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Scan4Safety

Improve Efficiency Improve Patient Safety Release Time to Care

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Thank You For Listening

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Closed loop of medication up to point-of-care scanningGlobal GS1 Healthcare Conference, 26 March 2019Sébastien Langlois-Berthelot

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Barcode Implementation on Roche Pharmaceutical ProductsSecondary vs. Primary Packaging

Percentage of marketed Stock Keeping Units worldwide (March 2019)

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Closing the loop of medication = Barcoding below unit of saleChallenges and Opportunities for pharmaceuticalmanufacturers

Challenges Opportunities

• Diversity of primary packaging (blisters, bottles, syringes, ampoules…)

• Small containers and labels

• Diversity of printing technology andpackaging equipment

• Adding Batch and Expiry Date requiressubstantial time and investment

• Manufacturers and Healthcare Providers are familiar with DataMatrix due tosecondary packaging implementation

• Identification of the product with a barcode will allow more safety at point ofcare scanning

• GTIN in the barcode already supportsright medication identification, e-prescription, bedside scanning and link to master data

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Roche’s Journey to Single Unit BarcodesFirst Attempts to Meet Hospitals Needs (2011-2016)

AMGROS Requirement in Denmark(except for blisters)

Voluntary implementation for all injectables in Switzerland

Voluntary implementation for infusionsolution vials for all EU countries (centrally registered products)

GS1 DataMatrix with GTIN only

Pictures for illustrative purposes only. Do not reflect the actual layout for the specific market.

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Roche’s Journey to Single Unit Barcodes Moving to the next level (since 2017)

• Voluntary implementation of single unitcoding (GTIN + Expiry Date + Batch Number) for vials for selected productsand markets

• Exploring technical possibilities toimplement on other types of containers(syringes, blisters)

• Full implementation will take time!

GS1 Position Paper on theidentification of the primary package

level of drugs (2017)Endorsed by

In parallel to technical preparation forinclusion of expiry date and batch, wewant to increase the number of primarypackaging with at least static GS1 DataMatrix (GTIN only) to support firstimmediate benefits for HealthcareProviders and Patients

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Benefits of including the GTIN in a DataMatrix on the primarypackaging

Beyond making product identification at point ofcare safer and more reliable, GTIN on primarypackaging allows a number of new opportunities:

• Link with IDMP (Identification of medicinalproducts): a set of ISO norms which support a harmonized nomenclature of pharmaceuticalproducts at different levels

• Ability to use GDSN (Global Data Synchronization Network) to share Primary Pack GTINs and product data attributes withHealthcare Providers

• Sharing of digital content (electronic leaflets, patient educational material) with the future GS1 Digital Link standard, currently in preparation

GS1 DataMatrix with at least a GTIN

GTIN Product DataIDMP NomenclatureDigital Content (e-leaflet, patient supporting material)

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Doing now what patients need next


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