gs1 healthcare reference book 2010-2011

Upload: naeem-ahmed

Post on 10-Apr-2018

213 views

Category:

Documents


0 download

TRANSCRIPT

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    1/56

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    2/56

    2 2010/2011 GS1 Healthcare Reerence Book

    Table o Contents

    GS1 Standards in Healthcare: Making a diference in the Healthcare supply chain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

    USA: U.S. FDA to establish unique identication system or medical devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

    Brazil: Pharmaceutical products traceability system pilot project in Brazil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

    UK: Coding or success Automatic Identity and Data Capture programme within the National Health Service . . . . . . . . . . . . . . . . .13

    Canada: Automating the medication use process: North York General Hospital Pharmacy Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

    USA: Keeping an eye on the big picture: Mayo Clinics integrated supply chain management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

    Hong Kong: Hospital Authority improves procurement process and asset management through EDI and RFID . . . . . . . . . . . . . . . . .25

    Chile: Improving quality o care and patient saety in Chile: Servicio de Salud Metropolitano Occidente . . . . . . . . . . . . . . . . . . . . . . . .28Japan: Medical inormation support system using Personal Digital Assistants (PDAs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

    Netherlands: Project Prometheus: Electronic administration within the blood transusion chain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

    Spain: Stock management o implants through RFID technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37

    Colombia: Supporting the implementation o a traceability system or the healthcare sector in Colombia . . . . . . . . . . . . . . . . . . . . . .39

    Germany: Bar codes and Co. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43

    Switzerland: Cytostatic treatment and bedside scanning: Improving patient healthcare at Geneva University Hospitals . . . . . . . . .45

    Australia: Health procurement leader turns to Australias National Product Catalogue to improve tendering . . . . . . . . . . . . . . . . . . . .48

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    3/56

    12010/2011 GS1 Healthcare Reerence Book

    GS1 Healthcare would like to thank the ollowing or contributing to this edition o the GS1 Healthcare Reerence Book:

    Patrcia Blanco, ETCO Brazilian Institute o Ethical Competition

    Pro. Pascal Bonnabry, Geneva university hospitals

    Jay Crowley, U.S. Food and Drug Administration

    Joe Dudas, Mayo Clinic

    Luiz Emlio Ferreira, ETCO Brazilian Institute o Ethical Competition

    Luis Gonzalo Giraldo Marin, Caja de Compensacin Familiar Caam

    Christian Hay, GS1 Switzerland and GS1 Global O ce

    Neil Lawrence, NHS

    Andr Franco Montoro Filho, ETCO Brazilian Institute o Ethical Competition

    Doris Nessim, North York General Hospital Dr. Carolina Cern Reyes, Servicio de Salud Metropolitano Occidente

    Benjamn Rodriguez Nespereira, Ourense Hospital Complex and the Galician Health Service Logistics

    Dr. Thomas Rothe, University Hospital Carl Gustav Carus, Dresden

    Dr. Kiyohito Tanaka, Kyoto Second Red Cross Hospital (K2RC)

    Tom Truman, Health Purchasing Victoria

    Erik Zwarter, Erasmus Medisch Centrum

    In addition, we would like to thank the ollowing GS1 Member Organisations or acilitating this process:

    GS1 Australia (contact: Tania Snioch [email protected])

    GS1 Brazil (contact: Ana Paula Vendramini Maniero [email protected])

    GS1 Canada (contact: Alicia Duval [email protected]) GS1 Chile (contact: Marcos Squella [email protected])

    GS1 Colombia (contact: Leonel Pava [email protected])

    GS1 Germany (contact: Bettina Bartz [email protected])

    GS1 Hong Kong (contact : Eric Chow [email protected])

    GS1 Japan (contacts : Michio Hamano [email protected] and Yasuo Kurosawa [email protected])

    GS1 Netherlands (contact: Hans Lunenborg [email protected])

    GS1 Spain (contact: Mnica Soler [email protected])

    GS1 Switzerland (contact: Christian Hay [email protected])

    GS1 UK (contact: Roger Lamb [email protected])

    GS1 US (contacts: Dennis Harrison [email protected] and Annette Pomponio [email protected])

    Welcome to the second edition of the GS1 Healthcare Reference Book (Edition 2010/2011)! After itssuccessful premiere in 2009, we are proud to present another compendium of information on theadoption and implementation of GS1 global Standards in the Healthcare supply chain. Experts from

    different countries and different backgrounds share their insights on important regulatory and industrydevelopments, adoption initiatives, lessons learnt from implementation projects and more. We hopethat you gain valuable information from this publication and we extend our appreciation to all thecontributors that have made this possible.

    Acknowledgements

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    4/56

    2 2010/2011 GS1 Healthcare Reerence Book

    Five years o advancing GS1 global standards in the Healthcare supply chain

    GS1 Healthcare would like to extend its thanks to the hundreds of people worldwide who have contributed to the voluntary global and

    local Healthcare user group activities, especially in the development and implementation of global standards. With your engagement

    and commitment, improvements to patient safety and supply chain effi ciency continues to advance worldwide, with the ever increasing

    recognition and adoption of GS1 global standards in Healthcare.

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    5/56

    32010/2011 GS1 Healthcare Reerence Book

    GS1 Standards in Healthcare:

    Making a diference in the Healthcare

    supply chain

    In light o a variety o concerns about patient saety and rapidly

    escalating Healthcare costs, governments worldwide are taking

    action and important policy changes are on the way. Some

    o them will have a direct impact on the Healthcare supply

    chain. Various authorities worldwide have developed, or are

    developing, regulations requiring automatic identication,

    serialisation and traceability systems in Healthcare to improve

    patient saety, including the European Commission, the US Foodand Drug Administration (FDA), the National Health Surveillance

    Agency in Brazil (ANVISA), the Ministry o Health o Turkey and

    the India Ministry o Health and Family Welare (MoHFW).

    GS1 Standards provide a global ramework that takes into

    account all these types o specic requirements or medical

    products (pharmaceutical and medical devices).

    In light o the same requirements, Healthcare providers, group

    purchasing organisations and associations worldwide have

    also announced that they will take action to drive adoption

    and implementation o GS1 global Standards in the Healthcare

    supply chain, including; Australia, Brazil, Canada, Chile, Columbia,France, Germany, Hong Kong, India, Japan, the Netherlands,

    Spain, Switzerland, Turkey, UK and USA.

    GS1 in Healthcare global reach

    GS1 has been working with the global Healthcare community or

    more than 5 years via its voluntary, global Healthcare user group:

    ABSTRACTGS1 Healthcare envisions a uture where the Healthcare

    sector utilises GS1 global Standards or all items, locations,

    people and processes, to drive patient saety and supply

    chain e ciency improvements starting with the

    manuacturer and ending with procedures or treatments

    or a specic patient.

    GS1 Healthcare. This group is leading the Healthcare sector to

    the successul development and deployment o GS1 global

    Standards by bringing together experts in Healthcare to enhance

    patient saety and supply chain e ciencies.

    Countless hours o vetting, o ine discussions, brainstorming and

    more than 10,000 contact hours (conerence calls and physical

    meetings) have now resulted in some important milestoneswith the publication o a set o ratied global standards or the

    Healthcare sector including; GTIN Allocation Rules or Healthcare,

    AIDC Application Standards or Healthcare and the Global

    Traceability Standard or Healthcare.

    GS1 in Healthcare local reach

    The main ocus o GS1 Healthcare is now on standards

    adoption and implementation. Standards development work

    will continue, but now we have reached a point where local

    Healthcare user groups and GS1 Member Organisations are

    driving adoption in their local communities and support the

    implementation o these standards throughout Healthcare.The global and local Healthcare user groups provide a neutral

    platorm or Healthcare supply chain stakeholders to exchange

    experiences and best practices, to enhance uture standards

    development and adoption.

    For more inormation about GS1 Healthcare, visit

    www.gs1.org/healthcare.

    Article by Ulrike Kreysa and Jan Denecker

    3010/2011 GS1 Healthcare Reerence Book

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    6/56

    4 2010/2011 GS1 Healthcare Reerence Book

    U.S. FDA to establish unique

    identication system or medical devices

    ABSTRACTOn September 27, 2007, the president signed into law the Food and Drug Administration

    (FDA) Amendments Act o 2007. This act includes language related to the establishment

    o a Unique Device Identication (UDI) System (section 226). This new system when

    implemented will require:

    The label o a device to bear a unique identier, unless an alternative location is specied by

    FDA or unless an exception is made or a particular device or group o devices. The unique identier to be able to identiy the device through distribution and use.

    The unique identier to include the lot or serial number i specied by FDA.

    I used by all healthcare stakeholders, UDI can improve visibility o device movement, recalls,

    post-market surveillance, adverse-event reporting, and anti-countereiting, among other

    benets. A properly implemented UDI will also acilitate the integration o medical device

    data across disparate IT systems, including those that support the supply chain, clinical and

    reimbursement unctions.

    ByJay Crowley

    Introduction

    Over the last ew years, the U.S. healthcare industry has rallied

    around establishing a unique device identication (UDI) system

    that will provide a platorm or communicating accurate, reliable

    inormation about medical devices to stakeholders who need

    inormation about the device. A UDI system will enable many

    benets, including aster and easier recalls, improved traceability,

    more efective countereit detection and abatement, increased

    accuracy in electronic transactions and inormation sharing,

    reduced costs and, most importantly in the healthcare industry,

    improved patient saety. For patient saety reasons, the U.S.

    Food and Drug Administration (FDA) is not only interested indeveloping a UDI system in the U.S., but would like to see the

    adoption o such a system globally or the healthcare industry.

    Challenges in medical device identifcation

    The U.S. medical device industry is diverse, and devices vary

    dramatically in size, complexity, packaging and use. Medical

    devices cover a wide range o products everything rom complex

    imaging systems, implants, hospital equipment and supplies,

    clinical lab products, dental care, home care and over the counter

    devices. Some items are packaged individually, others in boxes,

    and some are not packaged at all. They may be implanted inpatients, used once and thrown away, used and reprocessed, or

    used or many years until next generation models are launched.

    Sharing inormation about a device is inherently complex. From

    the time a device is manuactured to the time it is used in patient

    care, inormation about the device is passed up and down the

    healthcare supply chain many times with all o the distributors,

    group purchasing organizations, hospitals and users in between.

    The lack o data standardization adds urther complexities to these

    interactions, as the inormation shared is otentimes inaccurate,

    duplicative, out o date or conusing.

    Today, hospitals and their suppliers use thousands o diferent

    numbers to electronically track devices. The U.S. Healthcare

    inormation systems are lled with inaccurate and manually created

    item and company names, and sel-created numbering systemsthat difer rom user-to-user and vendor-to-vendor, creating an

    environment or data exchange that is raught with errors and

    inconsistencies which creates both ine ciencies throughout the

    supply chain and potential impact on patient saety.

    Lack o consistent device identiers in healthcare has been

    a long-standing problem, yet is one that can be solved with

    the industry-wide adoption o consistent global identication

    standards across the industry and the implementation o systems

    to provide accurate data throughout the healthcare system. Ater

    many years o research and industry input, hospitals, distributors,

    manuacturers and other key stakeholders are now comingtogether to collaborate on the use o data standards to improve

    patient saety.

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    7/56

    52010/2011 GS1 Healthcare Reerence Book

    The solution: Critical visibility through UDI

    The FDAs Sentinel Initiative is intended to strengthen FDAs

    ability to query data systems or relevant device inormation

    ater a device is on the market. In todays environment, with

    no UDI system in place, there are many challenges in doing so.

    UDI will vastly improve our understanding o medical device

    use, post-market surveillance, and adverse event reporting. UDI

    will acilitate the ability to identiy and locate medical devices,

    whether physically in route to a hospital or recorded in a patients

    EHR, or in hospital inormation systems.

    Inaccurate and inconsistent data about medical devices

    plague the healthcare system today, with potential serious

    consequences. For example, in 2007, the FDA received more

    than 100,000 reports o adverse events associated with medical/

    surgical devices: 15% o the reports lacked model or catalognumbers, 50% o the reports lacked lot numbers or other

    production identiers, and more than 10% lacked needed

    inormation in both categories. Because there is no consistent,

    systematic way to gather inormation about these devices,

    the FDA receives inormation that varies widely rom one

    reporter to the next. With a UDI system in place, the reporting o

    adverse events would be more seamless, with more complete

    inormation, so that the FDA can strengthen its ability to monitor

    the saety and efectiveness o device use and adverse events

    and take action when needed.

    Also in 2007, manuacturers issued more than 1,000 recalls. A

    single recall can represent thousands to hundreds-o-thousands

    o individual items, ranging rom disposable devices to testing

    strips to implantable devices. In a recall situation, limited

    inormation causes delays in identiying and removing recalled

    items rom the shel. The problem is urther compounded i

    the device is an implantable, as tracing it to the patient can be

    extremely di cult and time-consuming. As shown in Figure 1

    Future Inormation Cycle with UDI in place, the use o UDI will

    allow improvements in the ability to identiy medical devices.

    Once a device is on the market, the FDA uses post-market

    surveillance tools to monitor patient saety and quality related

    to the use o the medical device. The UDI will also help improve

    the ability to nd medical devices, wherever that item may be

    an important ability when considering recalls, or example.

    Consistent, accurate inormation about medical devicescommunicated in a language all players can understand has

    an important role in improving patient saety. In addition, it is

    important that the implemented UDI system will address needs

    beyond the U.S., serving as a basis or accurate and sharable

    inormation globally.

    U.S. FDA to establish unique identication

    system or medical devices

    Expiration date?

    Reimbursement

    Clinical Use

    EHR

    AE reporting

    Surveillance

    Closed System

    Hospital

    Distributor

    Manuacturer

    Recall

    Countereit

    UDI

    Device XLot/Serial YExp Date Z

    Population database

    Registries

    Sae?

    Recalled?

    Efectiveness

    Figure1: Future Inormation Liecycle

    Re/Order

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    8/56

    6 2010/2011 GS1 Healthcare Reerence Book

    In 2008, the Global Harmonization Task Force (GHTF), an

    international partnership between regulatory authorities and

    industry, established an ad-hoc unique device identication

    working group to acilitate a global approach to UDI.

    Creating an implementable UDI system

    Only a ew people will actually physically touch a medical device,

    but many more constituents will need to know inormation

    about that item, including patients, clinicians and researchers.

    The FDA would like to create a UDI system that is:

    Consistent

    Unambiguous (diferentiates among all dimensions)

    Standardized

    Unique at all levels o packaging Harmonized internationally

    The FDA sees the establishment o a UDI system taking place in

    our distinct steps:

    Create a standardized UDI, it must use globally accepted

    standards or device identication.

    Require the UDI to be placed in human readable and/or

    AutoID ormat, directly on the device, its label, or both. It is

    important to remain technology neutral in this area and will

    not establish a rule dening which data carrier (i.e. linear bar

    code, 2D data matrix bar code) to use. Create and maintain a UDI Database that acilitates the

    storage, exchange, and integration o data and systems.

    Drive adoption and implementation. The entire industry must

    work together to make UDI work.

    U.S. FDA to establish unique identication

    system or medical devices

    The UDI System: Making useul inormation available

    Establishing a UDI System

    Combination o 4 distinct steps:

    1 Develop a standardized system to develop the unique

    identiers (UDI)2 Place the UDI in human redable and/or Auto ID on a

    device, its label, or both

    3 Create and maintain the UDI Database

    4 Adoption and Implementation

    Advantages o UDI

    UDI Can Improve... Visibility

    Medical device recalls

    Adverse event reporting and postmarket surveillance

    Tracking and tracing, supply chain security; and

    anticountereiting/diversion

    Comparative efectiveness (e.g. registries)

    Disaster/terror preparation and shortages/substitutions

    Reduce medical errors

    Documenting medical device use in patients EHR/PHR,

    hospital inormation systems, claims data

    Sentinel Initiative strengthening FDAs ability to query

    data systems or relevant device inormation

    The long road to UDI

    In 1999, the Institute o Medicine published a study that revealed

    as many as 98,000 people die each year as a result o medical

    errors1. Automation o many o the key processes involved in

    patient care delivery could help prevent many o the mistakes

    that happen in the hospital setting. As such, the FDA issued its

    Pharmaceutical Bar Code Rule in 2004, which applies to certain

    human drugs and biological products and requires that a linear

    bar code containing the National Drug Code (NDC) number be

    placed on these product labels. The Bar Code Rule helps acilitatesystems to ensure the ve rights o medication delivery by

    enabling healthcare proessionals to check whether they are

    giving the right drug via the right dose and right route o

    administration to the right patient at the right time.

    Realizing that the same potential or error exists when

    using medical devices, in 2005 the FDA began to look at the

    possibilities or bar code standards or medical devices. The FDA

    issued calls or comments, held workshops and public meetings.

    The FDA Amendments Act o 2007 includes language requiring

    the FDA to establish a UDI system (section 226). This new system

    requires:

    The label o a device to bear a unique identier, unless an

    alternative location is specied by FDA or unless an exception

    is made or a particular device or group o devices.

    The unique identier to be able to identiy the device through

    distribution and use.

    The unique identier to include the lot or serial number i

    specied by FDA.

    The FDA is interested in adopting global standards in an

    unambiguous way, with an understanding that the promised

    benets o UDI can only be realized i used by all stakeholders.

    1 To Err Is Human: Building a Saer Health System. Institute o Medicine (1999).The National Academies Press.

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    9/56

    72010/2011 GS1 Healthcare Reerence Book

    U.S. FDA to establish unique identication

    system or medical devices

    Figure 2: GHTFs recommendations

    or core identifcation attributes are3:

    Unique Device Identication Code

    This is the static part (device identier) o UDI code.

    Manuacturer Name

    Manuacturer Contact Inormation

    Address, including Country Name and Contact Point

    inormation.

    Nomenclature

    Global Nomenclature code (e.g. GMDN). Device Name (generic name)

    Trade Name (brand name)

    Device model number (or reerence number)

    Controlled by serial and/or lot/batch number and/or

    manuacturing and/or expiration date - check box [ ]

    Quantity and Packaging level

    E.g. Box o ten items, kit o 100 tests

    Size including units o measures (volume / )

    Device size when it is needed clinically, (e.g. 8F catheter).

    Storage conditions (as labeled on the product and/or the

    IFU) (e.g. needs to be rerigerated)

    Labeled as single use check box [ ]

    Sterility

    Package Sterile Yes/No

    I Yes: Sustainability o the sterile package ()

    Need to be sterilized beore use Yes/No

    Restricted number o use (number)

    Only i the devices label indicates a limited number o use.

    Labeled and /or IFU (Instructions or Use) as containing

    allergens/materials o concern Yes/No

    I YES

    Indicate the name o the allergens/materials o concern

    (e.g. Latex) (limited list to be dened and managed by theGHTF)

    Regional authorised representatives as labelled (list o

    countries)

    Inormation about the regional representatives

    inormation such as the address or telephone number,

    when applicable.

    URL or additional inormation Web address

    Special Instruction or use I it is necessary to inorm to

    the user about special indication or the device, such as:

    Contraindications, Intended Use or Part o Use, etc.

    3 Drat attributes as o March 31, 2010.

    In order to implement a UDI system, we need to be able to make

    inormation about medical devices available to people who

    need it. The UDI code will include product static inormation

    (device identier) and may also include dynamic inormation

    (production identiers). The static part o the UDI code identies

    the specic device. A signicant change to any o the device

    characteristics would require that a new UDI code be allocated

    to the device. The dynamic part o the UDI code identies

    production inormation about a particular device (i.e. the lot

    number, serial number or expiration date).

    The UDI code is developed and maintained by the manuacturer.

    It should be both human readable and encoded in a orm o

    automatic identication technology (such as a bar code). Some

    devices may have direct part marking (DPM), such as implants

    and those that require reprocessing, cleaning, or sterilization

    between patients use.

    A UDI Database (UDID) will contain certain identiying attributes

    or each device. It will not include dynamic inormation, pricing

    or other manuacturer-proprietary inormation. Recently,

    the GHTF released a call or comments or guidelines or the

    development o a global UDI system including attributes that

    might be included in a global UDI database2 (See Figure 2).

    2 GHTF Discussion Paper (in view o preparation o a drat guidance on) UDI orMedical Devices: Unique Device Identication (UDI) System, GHTF, 2009

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    10/56

    8 2010/2011 GS1 Healthcare Reerence Book

    The FDA recently completed a pilot test o a prototype UDID. The

    goal o the pilot was to assess the easibility o collecting, storing

    and retrieving UDI data rom device creation (manuacturer)

    to point o use (hospital). Hospitals viewed the concepts or

    the UDID avorably, as the UDID prototype provided the data

    hospitals regularly need. Some manuacturers experienceddi culties during the pilot and are currently working through

    challenges they experienced in the pilot with data denitions,

    the ability to obtain data rom various sources and working with

    the data ormats or the UDI upload.

    Looking to the uture: The time is right now!

    Looking down the road, a ully actualized UDI system will provide

    the oundation or improved patient saety, as it will enable

    more e cient and efective device recalls, improved post-

    market surveillance, better adverse event reporting, and better

    device identication in registries. UDI will give us the ability to

    document specic device use in patients and to track devicesin patients electronic health records. The FDA will be able to

    conduct better population-based results rom device usage. The

    saety benets o a UDI system however can only be realized i

    the UDI is captured, stored, integrated and exchanged by ALL

    stakeholders.

    In addition, UDI will acilitate better inormation sharing, as data

    will be integrated across disparate systems. With this integration

    comes insight and visibility to assess the efectiveness o devices

    in certain patient populations or in particular environments.

    This is especially important when investigating ways to reduce

    medical errors.

    ABOUT THE AUTHORJay Crowley, Senior Advisor or Patient Saety, U.S. Food

    and Drug Administration

    Jay Crowley is Senior Advisor or Patient Saety in

    FDAs Center or Devices and Radiological Health. Jay is

    interested in developing new methods and techniques

    to identiy, analyze, and understand problems occurring

    rom medical device use within the healthcare

    environment. He has been working at FDA or nearly 20

    years in a variety o positions. Jay holds degrees in RiskAnalysis and Engineering.

    The Global HarmonizationTask Force (GHTF)

    The Global Harmonization Task Force was conceived in

    1992 in an efort to achieve greater uniormity between

    national medical device regulatory systems. This is being

    done with two aims in mind: enhancing patient saety and

    increasing access to sae, efective and clinically benecial

    medical technologies around the world.

    A partnership between regulatory authorities andregulated industry, the GHTF is comprised o ve

    Founding Members: European Union, United States,

    Canada, Australia and Japan. The chairmanship is rotated

    among the Founding Members and presently resides with

    Canada. For more inormation, go to www.ght.org

    U.S. FDA to establish unique identication

    system or medical devices

    Exposure to the allergen latex is a signicant concern in the

    healthcare setting. The UDI database will help to identiy which

    devices contain latex and, as such, will help prevent exposure

    to latex in the uture. UDI will help the healthcare community

    understand and determine the role medical devices play in

    medical errors across patient populations.

    Ater many years o industry mobilization around establishing

    a UDI in the U.S., the time is right or a UDI system. An increased

    ocus on the benets o inormation technology in healthcare

    (the U.S. governments investing more than $19 billion to

    improve IT inrastructure in the U.S. healthcare system) and

    greater attention to reducing medical errors are adding to the

    urgency. The FDAs vision is a UDI system that is integrated and

    harmonized with global eforts to ensure patient saety benets

    are realized worldwide.

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    11/56

    92010/2011 GS1 Healthcare Reerence Book

    Pharmaceutical products

    traceability system pilot project in Brazil

    ABSTRACTIn order to break the vicious circle in the pharmaceutical

    market in which illegalities imply serious risks to public

    health, ETCO (Instituto Brasileiro de tico Concorrencial,

    the Brazilian Institute o Ethical Competition) and the

    companies linked to the Pharmaceutical Chamber have

    entered in a partnership with the government. And,

    in a combined efort, we tested a simple and e cient

    mechanism, which can electronically track the course o anyand every drug sold in Brazil. This article describes the new

    legislation establishing the obligation o such traceability

    system, and the lessons learned o the pilot organised by

    ETCO in collaboration with ANVISA (National Agency o

    Sanitary Surveillance).

    By Andr Franco Montoro Filho, Patrcia Blanco,

    and Luiz Emlio Ferreira, ETCO

    The pharmaceutical market in Brazil

    A study o the pharmaceutical market in Brazil conducted in 2005by the McKinsey consultancy o ce and the Pinheiro Neto law rm,

    by ETCOs request, showed that the high degree o the existing

    inormality severely damages the industry and society as a whole.

    The study conclusion was that inormality must be ought with

    a set o specic actions, including the implementation o a

    traceability and authentication system, which aims at allowing a

    ollow-up o each step o the pharmaceutical products, rom the

    plant to the nal consumer.

    In accordance with inormation provided by IMS Health

    (December 2008), the Brazilian pharmaceutical market

    accounts or more than one billion units o Ethical productsand 600 million OTC drugs. According to companies estimates,

    500 million drugs are directly sold to hospitals. The whole

    pharmaceutical chain comprises approximately 450 companies,

    over 2,000 wholesalers and a huge chain o 56,000 retail

    pharmacies and drugstores.

    Fighting countereiting in Brazil: legislativedevelopments

    The risks to the Public Health and the losses resulting rom

    drugs manuactured in non-compliance with the norms

    and procedures adopted present incalculable dimensions.Brazilian authorities and companies have been long seeking or

    mechanisms to restrain illegality.

    In July 2nd, 1998, the National Congress qualied the

    countereiting o pharmaceutical products and raw materials as

    hideous crimes against public health, as dened in the Law no.

    9,677/98. In this same year, the Secretary o Sanitary Surveillance

    o the Ministry o Health enacted the Administrative Rule no.

    802/98, which instituted the Control and Inspection System or the

    whole chain o pharmaceutical products. The popular raspadinha

    (a scratch-of label with a reactive ink that helps in the verication

    o the authenticity o the drugs), the inviolability o the packagesand the identication o the batch number in commercial

    transactions are some o the innovations established by that norm.

    In 2002, the Administrative Act RDC no. 320 established that the

    wholesalers o pharmaceutical products should start to execute

    the commercial transactions and circulation operations with sale

    bills that presented, mandatorily, the products batch number.

    In spite o those measures, the level o inormality in the Brazilian

    pharmaceutical industry is still alarming. Along the whole year

    o 2008, ANVISA seized approximately 45 tons o unregistered,

    smuggled and countereited products. According to ANVISA,

    in the rst semester o 2009, 316 tons o ake medicines wereseized. Another important issue is the cargoes thets in the

    Brazilian cities and highways. In 2007, approximately 11,700

    cargoes were stolen across the whole country, according to

    inormation provided by NTC & Logstica (National Association

    o Cargo Transportation and Logistics). The estimated gure or

    2008 is even higher: 12,400.

    In March 4th, 2008, ANVISA published the Public Consultation

    no. 8. aiming at receiving reviews and suggestions associated

    to the minimum requirements or the denition o mechanisms

    to track the pharmaceutical products chain and to guarantee

    their authenticity. The purpose was to identiy solutions thatcould allow the implementation o systems o drug tracking and

    authentication in the whole chain o pharmaceutical products.

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    12/56

    10 2010/2011 GS1 Healthcare Reerence Book

    Industry

    The manuacturer will be

    responsible or printingthe Unique Drug Identier(UDI) both on thesecondary packages o itsmedicines and on logisticunits (cases or pallets) inerence labels.1 The codewill contain the ollowinginormation, initially sentto a private database andthen to a central database: Product identication

    (GTIN); Batch number;

    1 The working denition o inerence as it applies here is that it reers to the ability to iner, based on tracking and validation o a unique identier

    attached to an aggregate package (e.g., pallet, case, tote) which has a hierarchicak relationship with unique

    Warehouse

    In case the manuacturer

    possesses its ownwarehouse, a productmovement will occurprevious to the billing,whose registration shouldbe present in the database.A similar situation occurswhen the company countson an outsourced logisticsoperator. In this case,the ollowing additionalinormation should be sentto the central database:

    Wholesalers

    As o receipt o the

    goods, the wholesalerwill be accountableor transmitting otherinormation, associatedto the commercialtransactions, to the centraldatabase: Date o the drugs arrival; Name o the retail

    pharmacy or drugstore.

    Retail Pharmacy

    The retailers will have to

    orward the ollowinginormation to the centraldatabase: Data associated to the

    purchase o the goods; Data o sale to the nal

    In January 14, 2009, the Law no. 11,903 was issued, which

    created the National System o Drug Control. The Bill was initially

    submitted by the Congresswoman Vanessa Grazziotin and

    carried out in the House o Representatives during two years.

    The Law establishes the tracking o all kinds o drugs existing

    in the country, rom their manuacture to their sale to the nal

    consumer. The control will be perormed by means o technologies

    or electronic capture, storage and transmission o data. Each

    product will have to display an exclusive identication code.

    The law establishes that the system will have to be totally

    implemented within a period o three years. At the end o

    this period, the drug control in Brazil should reach levels o

    excellence, ensuring, in addition to the traceability, an efective

    monitoring about the drugs use and prescription.

    Enabling pharma traceability in Brazil:the pilot project

    With the purpose o collaborating with ANVISA in the

    implementation o a tracking and authentication system, the

    ETCOs Pharmaceutical Chamber has submitted to the regulatory

    agency the proposition o developing a pilot project. The

    consolidation o eforts was discussed and the nal agreement

    was signed in December 18, 2008.

    From January to July 2009, ETCO conducted the pilot test o the

    Traceability System Pilot Project, supported by technicians rom

    ANVISA. According to the Technical Cooperation Protocol, the

    Institutes work aimed at helping the regulating agency to dene

    the best technological solution to efectively ght inormality in

    the pharmaceutical industry.

    Pharmaceutical products traceability

    system pilot project in Brazil

    Surveillance

    The Traceability Systemwill ensure that inspectionagents have access totraceability data or alldrugs, rom the point omanuacturing to thepoint o sales or point odispense.

    System design

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    13/56

    112010/2011 GS1 Healthcare Reerence Book

    Pilot planning

    The pilot test was established in diferent stages, in order to

    evaluate a signicant representation o the industrys reality.

    In the rst stage o the project ETCOs group detected and

    mapped needs and expectations o its partners: companies,

    wholesalers and retailers. In the second stage, the practical

    section o the pilot test, which was put into operation in June

    2nd, 2009, was executed. In the course o approximately 40 days,

    the processes o printing and scanning the identication codeson the secondary packages were assessed, and the collection

    and transmission o all inormation generated by the companies

    participating in the initiative was equally evaluated.

    Pilot participants and operational ow

    For the test an adequate volume o drugs was adopted

    (approximately 75 thousand) in order to support improvements

    and changes o route in the processes.

    COMPANY PRODUCT AMOUNT

    Ach(Biosinttica) BROMOPRIDE 1 mg/ml bottle w/ 120 ml 3,333

    Bayer ADALAT RETARD 10 mg w/ 30 tablets 29,800

    Euroarma ASTRO 500 mg display w/ 60 tablets 1,650

    Mantecorp CELESTAMINE syrup 120 ml 9,600

    Nycomed RIOPAN suspension 240 ml 14,350

    Pzer PONSTAN 500 mg w/ 24 tablets 14,000

    Sano-Aventis DORFLEX box w/ 30 tablets 3,000

    TOTAL 75,733

    GS1 Brazil was responsible or the denition o international

    standards o coding, the entity acted as a certier o the quality

    o the codes printed on the packages.

    Open technological solutions o public domain were adopted to

    allow the required technical exibility to meet the specicities o

    each companys processes.

    Adoption o several technologies or item marking:

    continuous ink-jet, laser and thermal ink-jet printers.

    Availability and exibility so that the pharmaceutical chains

    agents could select the equipment or the electronic capture

    o data (DataMatrix scanners) that was more compatible with

    their industrial and commercial processes. Equipment with low, medium and high speed and

    complexity, usually utilised by the whole pharmaceutical

    chain, was tested.

    Adaptation o the inormation technology systems o the

    pharmaceutical chain companies, so that the whole tracking

    process was put into operation in a validated orm.

    Adoption o an identication system, so that all essential

    inormation required or the tracking can be captured rom each

    medicine package.

    The two-dimensional barcode, internationally accepted -

    GS1 DataMatrix (ECC 200), was adopted and printed on thesecondary packages. The barcode included the ollowing

    inormation about the product: GTIN, batch number, expiry

    date, and serial number.

    Usage o GS1-128 bar code with SSCC key on the logistic unit

    (case) to ensure the link with the content (secondary packs).

    The data obtained during the test, rom the manuacture to the

    point o purchase, were stored in a central database, allocated in a

    data center, in order to reect what should occur in the real model.

    Every change o establishment was inormed to the system in all

    o the tested stages: reception, incorporation to the inventory

    and sorting or the dispatch. The UDI liecycle begins with thegeneration o a serial number and its storage in a database.

    Pharmaceutical products traceability

    system pilot project in Brazil

    Pilot participants and operational ow

    ACHE BAYER EUROFARMA MANTECORP NYCOMED PFIZER SANOFI

    Each company produced one batchShipping boxes scanning

    Manuacturers

    Wholesalers

    and Retail chains

    11 pharmacies and

    drugstores, in the cities

    o Belo Horizonte,

    Fortaleza, Rio de Janeiro

    and So Paolo

    Individual package scanning

    Return to the Wholesaler

    PROFARMA PANARELLO SANTA CRUZ

    Pharmacy 1 Pharmacy 2

    DROGASIL DROGA RAIA PAGUE MENOS DROGARIA ARAUJO

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    14/56

    12 2010/2011 GS1 Healthcare Reerence Book

    ABOUT THE AUTHORSAndr Franco Montoro Filho is Chairman o the Brazilian

    Institute o Ethical Competition ETCO, a non-prot

    organisation that congregates non-government and

    entrepreneurial that aims to establish ethical parameters

    or competition. Mr. Montoro is Ph.D. in Economics rom

    Yale University (USA), is ull proessor o the Economics

    and Administration College o the University o So Paulo

    (Brazil). He was Secretary o Economy and Planning o the

    State o So Paulo and President o the Brazilian Economicand Social Development Bank (BNDES) rom 1985 to 1988.

    Patrcia Blanco was Executive Director o ETCO Brazilian

    Institute o Ethical Competition. Patricia was responsible

    or the management o the ETCOs project pilot o the

    pharmaceutical products traceability system.

    Luiz Emlio Ferreira is Coordinator o the Pharmaceutical

    Chamber o ETCO Brazilian Institute o Ethical

    Competition, which has worked with associated

    companies on the traceability system. Prior to joining

    ETCO, Luiz Emilio worked or more than 16 years inGlaxoSmithkline.

    Pharmaceutical products traceability

    system pilot project in Brazil

    Lessons learned

    During the tests, no insoluble technical di culty was

    detected in the implementation o the unitary coding

    technology in the manuacturers packing lines.

    The choice o the adequate technology was based on the type

    o the manuactured products, the boxes layout, the packing

    lines speed, and the packing process, among other aspects.

    The available packing materials were used and some

    parameters o printing quality o the DataMatrix codes did

    not integrally comply with the GS1s recommendations.

    The tests showed, however, that occasional problems in the

    processes o code application and scanning are solvable.

    Regarding to the required equipment and sotware solutions,

    there are several companies in the market that can provide

    technologies complying with the specic demands o each

    link o the pharmaceutical chain. Investments on equipment, training courses and

    inrastructure should also be taken into consideration. Every

    proessional directly involved in the production, storage and

    dispatching process should be trained in the traceability

    concept. They should understand that each box will be dealt

    with as a single package by the whole pharmaceutical chain.

    Important aspects were identied, which should be taken

    into consideration by the agents o the pharmaceutical chain

    and the regulatory authorities in order to ensure a greater

    e ciency in the implementation o the system.

    The mobilisation and gathering o orces o all o the key

    stakeholders, besides the support and availability ordiscussion rom the ederal government, are crucial or the

    denition o the best possible system, to be executed within

    the period established by law.

    The DataMatrix printing process was also tested in a logistics

    operator, where ink-jet printers and scanners were installed

    in a conveyor belt, out o the packing line, in which over

    10 thousand boxes were printed and scanned. The test

    evidenced that, in a controlled environment, it is possible

    to obtain a printing level in the same standard ound in the

    manuacturers packing lines, taking into consideration the

    Good Manuacturing Practices.

    Conclusion

    The purpose o ETCOs Pharmaceutical Chamber was to test

    a traceability system as close as possible to the reality o the

    pharmaceutical chain and to demonstrate its easibility. The pilot

    project totally ullled its purpose o providing guidelines to all

    agents in the pharmaceutical chain or the implementation o the

    National System o Drug Control. The system can be implemented

    with the adoption o open technological solutions, o public

    domain, with characteristics and exibility to be used by the

    companies regardless o their size. The pilot test showed the

    advantages o the direct printing model with open technologies.

    The major paradigm change is the introduction o the unitary

    codication, which is crucial or the achievement o the required

    tracking level or compliance with the Law.

    About ETCO

    Created in 2003 as a public interest entity o the civil society,

    ETCOs basic mission is to oster an ethics-based competition,

    ghting the competition unbalances generated by countereiting,

    tax evasion, smuggling and other business conduct deviations.

    Such practices result in illicit advantages or the transgressors,

    harming the companies that comply with the laws. Thus, the

    ethical companies nd themselves discouraged to invest, to

    innovate and to grow, opening more room or illegalities.

    12 010/2011 GS1 Healthcare Reerence Book

    ETCO,GlaxoSmithkline.

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    15/56

    132010/2011 GS1 Healthcare Reerence Book

    Coding or success Automatic Identity

    and Data Capture programme within the

    National Health Service

    Introduction

    The Department o Health (DH) conducted a review o patient

    saety within the NHS in 2006 and some o the ndings were

    o great concern to parliament, the NHS and the permanent

    secretary o the Department. The main nding o the reportwas that 1 in 10 patient admissions into the NHS results in some

    kind o error, thus costing the NHS an estimated 2billion per

    year in additional, avoidable hospital days. (C. Vincent, G Neale,

    M Woloshynowych (2001) Adverse events in British hospitals.)

    The report also ound that at least hal o these errors were

    preventable. These ndings led to the development o the vision

    within the DH that the patient should have 5 saety rights

    The 5 Patient Rights

    Ensuring that the right patient

    Is given the right treatment

    In the right dose

    Through the right route At the right time

    This was reinorced by the Darzi report which reviewed the saety

    o the NHS, and stated that

    Our vision should be an NHS that is sae, as sae as it possibly

    can be, giving patients and public the confdence they need

    in the care they receive.

    Lord Darzi

    In 2007, the Department o Health published the guidance

    document Coding or Success. The document had been writtenin partnership with The Department o Health, The National

    Patient Saety Agency, The Medicines and Healthcare Regulatory

    ABSTRACTIn February 2007, the Department o Health published a best practice guidance document

    titled Coding or success (Simple technology or saer patient care) which advised that, in order

    to address patient saety issues, the National Health Service (NHS) should adopt GS1 coding

    standards provided to help eradicate patient saety issues in the NHS. This work has been

    adopted and driven by NHS Connecting or Health (CFH), the Department o Healths agency

    which is responsible or delivery o the NHSs National Programme or IT. The Automatic

    Identity and Data Capture (AIDC) programme has since driven adoption o GS1 UK standards

    by over 250 English Trusts operating in many diferent acets o healthcare.Article by Neil Lawrence,

    Programme Leader or

    AIDC technologies, NHS

    Authority (MHRA), NHS Connecting or

    Health and The Purchasing and Supplies

    Agency. It strongly recommended that

    both industry and the NHS should adopt

    the GS1 System o Standards and set out

    an action plan to support both the NHSand healthcare industry sector.

    Shortly ater the publication o the

    document, NHS Connecting or Health

    entered into an agreement with GS1 UK, to lead a programme

    o work or the NHS to drive adoption and use o the coding

    standards to reduce patient saety risk.

    Ater the announcement that NHS CFH were entering into an

    agreement with GS1 UK, Lord Hunt (the then Minister or Health)

    issued a statement to parliament advocating the programme

    and the adoption o GS1 coding standards in healthcare.

    By ocusing on key areas o healthcare, and working with

    other healthcare agencies and liaising with the industry and

    manuacturing side o healthcare, CFH has been able to make a

    huge success o the programme and to inuence healthcare end

    to end, rom manuacturer to patient to ater care.

    Connecting or Health and GS1 UK

    The contractual agreement that is in place between CFH and

    GS1 UK provides the NHS with proessional standards services

    allowing or the easiest and best led implementation o AIDC.

    NHS CFH provides vital governmental liaison expertise while

    working with manuacturers, solution providers, suppliers

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    16/56

    14 2010/2011 GS1 Healthcare Reerence Book

    and - most importantly - the NHS to drive adoption o the GS1

    Standards. NHS CFH also provides NHS organisations with

    membership to GS1 UK at no cost to the NHS.

    GS1 UK provides support, expertise, acilitation, project and stan-

    dards documentation and a dedicated service desk to the NHS.

    This joint approach has reaped great rewards over the past 3

    years and should ensure continued success into 2010.

    Key Focus areas

    To make the programme manageable and achievable, the

    adoption was broken down into ocus areas allowing the

    expertise o GS1 UK to be more Genre specic. Below are some

    examples o these areas.

    Sterile services

    Errors in the decontamination cycle have been well publicised.

    NHS CFH, GS1 UK and the DH national decontamination

    programme are all working to solve lost instruments, lack

    o track and trace, loss o revenue due to poor availability,

    postponed procedures and other issues .

    The ability to track and trace instrumentation across the NHS is

    invaluable and coding solutions have been progressing well over

    the last ew years. Tray level tracking is now available, through

    loan sets and in-house equipment. Direct part marking is alsoprogressing and that would bring a ull track and traceability

    across the NHS. The development o the super centres or the

    decontamination cycle has presented an ideal opportunity to

    The National Health Service

    The National Health Service was ormed in 1948 as a public

    health service in Britain.

    The NHS is the 2nd largest employer in the world and has

    some 1.3million staf, o which 77% are emale.

    Nursing staf make up over 30% o the workorce

    The NHS serves more than 1.5million patients everyday

    and 23 million people visit their general practitioner each

    month

    1.4million people receive care in their homes every week.

    Community pharmacies process more than 745 millionprescriptions every year

    Since the NHS was established in 1948, men and women in

    England live an average o 10 years longer.

    The main benet o the programme is the improvement o

    patient saety in the NHS. There are also other benets that

    have been realised:

    Cost reduction

    Time and efort saving Removal o paper processes

    Greater data usage

    Reduction o human intervention

    Service is more patient-centered

    Opportunity to inline NHS with Industry

    Anti-countereiting benet

    Great increase in track and trace

    Single data set leads to greater e ciency in processing

    Coding or success Automatic Identity and Data Capture

    programme within the National Health Service

    introduce coding standards to surgical devices o all kinds. With

    NHS CFH, the NHS supply chain, the DH, GS1 UK and the solutionprovider community involved, coding in sterile services and

    theatre management will continue to improve.

    Pharmacy and medicines manuacturing

    Coding in the pharmaceutical world is being adopted to reduce

    errors in prescription, and to assist with administering, validation,

    dispensary issues, packaging issues and waste management.

    Coding solutions are being adopted throughout the pharmacy

    sector rom manuacturers, to suppliers to repackaging and

    over labelling units, manuacturing units in trusts and hospitaldispensaries. Robotic dispensing which is being used in some

    trusts also works with GS1 UK standards.

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    17/56

    152010/2011 GS1 Healthcare Reerence Book

    Legislation stating that all outer packaging o pharmaceuticals

    must carry unique identication codes may come into efect in

    the next 6 months. The MHRA is currently working with the other

    regulatory bodies across Europe to take this orward. This move is

    a counter measure to the countereiting o drugs which is a huge

    problem in the medicines world, but one that can be addressed

    through unique coding.

    Patient Identifcation

    A study carried out at Charing Cross hospital, as part o

    Coding or Success ound that patient ID checks were only

    being undertaken 17% o the time. When bar-coded wrist

    bands were implemented they were checked 81% o the time

    Through simply issuing a unique NHS Number, bar-coded

    wristband to every in-patient in a hospital, we can greatly

    increase the positive identication o patients beore, during

    and ater care. The unique nature o this NHS CFH identier also

    enables cross reerencing to treatment and ensures direct access

    to patient records.

    NHS CFH has been working with the National Patient Saety

    Agency (NPSA) and GS1 UK to have Saer Practice Notice (SPN)

    No. 24 published to try to ensure that the benets associated

    with bar-coded wristbands. This stated that, by September 18th

    2009, all Trusts should have taken action towards using the NHS

    number bar code on patient wristbands.

    The NPSA Saer Practice Notice No. 24 (3 July 07) Standardizing

    wristbands improves patient saety can be ound at www.npsa.

    nhs.uk/nrls/alerts-and-directives/notices/wristbands.

    The standard or encoding the NHS number is ratied by

    the Inormation Standards Board and backed by NPSA Chie

    Executive O cer, Martin Fletcher.

    Through working with the NPSA, DH and ISB agencies and the

    NHS Number programme, holding workshops and collaborating

    with the procurement hubs and the OGC, we have enabled

    widespread adoption o wristband technologies.

    Coding or success Automatic Identity and Data Capture

    programme within the National Health Service

    Each ag represents a

    Trust that has adopted theprogramme and had a GS1

    UK pre-x assigned.

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    18/56

    16 2010/2011 GS1 Healthcare Reerence Book

    ABOUT THE AUTHORNeil Lawrence is the programme leader or AIDC

    technologies in the NHS. Beore working or Connecting

    or Health, he worked or many years in the nancial sector

    or companies Capital One and GE Money. Neil is greatly

    involved with GS1 UK, and sits on the global regulatorsbody as well as the UK HUG and UK Technical Committees.

    Coding or success Automatic Identity and Data Capture

    programme within the National Health Service

    The Coding or Success programme has been driving

    adoption with the NHS or 3 years with great success. Some

    examples o this are:

    Over 260 trusts signed up to the programme

    National backing o the programme rom government

    agencies

    Parliamentary backing o the programme

    Positive media coverage o all aspects o the programme

    E-learning and internet tools delivered by NHS CFH to help

    Trusts adopt the standards

    AIDC documentation written and available to the NHS to

    assist adoption

    5 key ocus areas established and piloted

    Use cases published to European audience

    UK Healthcare user group established Positive coverage o the programme worldwide

    Joint approach to wristband programme with the National

    Patient Saety Agency has led to mandated standards in

    the NHS

    Lord Hunts statement to parliament:

    Auto identifcation is not a new technology weve all been used

    to bar codes in supermarkets or years. But to reap the benefts

    in healthcare everyone needs to work to agreed standards. Weare recommending that both industry and the NHS should use

    the GS1 UK System or coding, and I am delighted to be able to

    announce that GS1 UK will be providing membership and support

    to NHS organisations who want to move orward on this.

    REFERENCES

    Coding or success:

    http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/

    PublicationsPolicyAndGuidance/DH_066082

    NHS Connecting or health E-learning

    http://www.connectingorhealth.nhs.uk/systemsandservices/etd/

    elearning

    The Darzi Report

    http://www.dh.gov.uk/en/publicationsandstatistics/publications/

    publicationspolicyandguidance/DH_085825

    Nurses waste an hour a shit

    http://www.nursingtimes.net/nurses-waste-an-hour-a-shit-nding-

    equipment/1987381.article

    Case studies can be ound at

    http://www.gs1uk.org/solutions/health/Further_inormation.asp

    Since the publication o SPN 24, the Inormation Standards Board

    or the NHS has also published guidance that all Trusts must be

    compliant with the SPN24 guidelines by June 2011, this has led

    to an increase in adoption by trusts.

    Document tracking

    Many clinical appointments in the NHS have to be re-scheduled,

    as patients notes cannot be located. This causes a signicant loss

    in terms o cost and wasted efort as many staf hours are lost by

    records staf, nurses and clinicians looking or notes and records.

    Through the adoption o GS1 coding, either in bar code or Radio

    Frequency Identication (RFID) ormat, these problems can be

    vastly reduced. The ability to locate a set o patients records

    almost instantly within the library or to know exactly which o

    a hospitals various department the notes have gone to, greatlyincreases e ciency and improves organisation. There is consid-

    erable evidence that implementation o the system has led to

    switer response times, improved staf morale and reduced cost.

    Pilots are being run currently to test two diferent RFID systems

    in the document tracking environment, and there are early

    indications that one o has already generated antastic benets.

    While these key ocus areas are the large ocus areas within the

    project we have many, many instantiations which are also being

    developed such as Healthcare GLNs, Real time tracking, Newborn

    baby screening, Blood tracking and supplies and materialsmanagement projects.

    Current status

    The signicant extent to which the programme has been

    adopted across England can be seen rom the map below.

    In summary the programme has been one o great success

    and under the guidance o NHS CFH will continue to drive

    adoption and encourage new ways o adopting the standards

    across the NHS. Through the selection o the key ocus areas

    and the development o them, a great number o health care

    proessionals have become advocates o the programmeand many more can see the direct benets it brings. Through

    workshops, seminars, conerences and hospital site visits along

    with the issuing o policy and guidance documents the adoption

    o AIDC in the NHS will continue to grow.

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    19/56

    172010/2011 GS1 Healthcare Reerence Book

    Automating the medication

    use process: North York General Hospital

    Pharmacy Services

    Background

    In Canada, the ederal governments healthcare arm Health

    Canada does not mandate bar coding o pharmaceutical (Rx)

    drugs. However, manuacturers are required to mark the product

    packaging with the drugs unique Drug Identication Number(DIN). DINs are assigned by Health Canada to a pharmaceutical

    product prior to it being marketed. The DIN is a computer-

    generated eight-digit number that uniquely identies all

    prescriptions and over-the-counter (OTC) drug products sold in

    Canada.

    However, the attributes associated with the DIN are limited; the

    DIN is not unique to the drug package hierarchy and does not

    enable globally unique identication o a product. This poses

    challenges in the implementation supply chain improvements.

    As well, the DIN does not support automatic identication

    technologies, which inhibits implementation o improved

    patient saety measures that would enable a healthcare providerto more efectively conrm that a particular medication is being

    administered to the right patient, at the right time, and in the

    right dosage.

    With these circumstances in mind, North York General Hospital,

    Pharmacy Services set about on a journey to identiy patients

    and drugs efectively and correctly, seeking a method to track

    and trace medications rom the point they enter the hospital,

    to when they are administered to patients. The goal was to do

    so by augmenting the capabilities provided by Health Canadas

    DIN and by meeting the hospitals Pharmacy Services bar coding

    criteria o unique and static inormation.

    By Doris Nessim,

    Director o Pharmacy

    Services, North York

    General Hospital

    ABSTRACTNorth York General Hospital in Toronto, Ontario, Canada is a 434-bed healthcare acility with

    approximately 2200 medications listed on its hospital ormulary. In the later part o 2005, the

    hospital began research to develop a bar coding strategy to reduce potential medication

    errors at the point o care, and to streamline their pharmacy operation processes. The outcome

    o research perormed by North York General Hospital, Pharmacy Services has resulted in its

    endorsement o GS1 standards or its bar coding strategy and leveraging their established

    criteria o using unique, static data that denes the Global Trade Item Number (GTIN)

    helping to move the healthcare sector to an increasingly e-driven global supply chain.

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    20/56

    18 2010/2011 GS1 Healthcare Reerence Book

    First steps

    Medication error literature consistently documents that

    approximately 39% o potentially serious medication errors occur

    at the point o administration. This is due to the act that, ater a

    medicine is administered to a patient, it cannot retracted. Types

    o medication errors that may occur include:

    Wrong patient

    Wrong drug

    Wrong dose

    Wrong dosage orm

    Wrong strength

    Wrong time

    Most signicantly, literature reports that only 2% o

    administration errors are actually caught prior to administration.

    The hospitals Pharmacy Services was determined in its goal

    to nd alternatives to the processes and solutions already in

    place in order to improve saety at the point o care, thereby

    preventing the types o errors reported in the literature. North

    York General Hospital has a culture o saety and believes that

    errors reect ailures in processes. No healthcare provider comes

    to work wanting to make a mistake. And while some errors

    simply cannot be identied by bar coding, the majority will be.

    The hospitals rst step was to take a systematic look at what it

    needed to do to improve its own medication error rates. Thiswas completed by methodically assessing the touch points o

    the hospitals medication-use process as a whole, which led to

    the identication o approximately three dozen touch points

    in all. As with any hospital, the medication-use process begins

    with procurement and inventory management, ollowed by

    dispensing the medication enabling the drug to be available at

    the point o administration or nursing units.

    As a result o its research o point o administration errors and its

    medication-use process, North York General Hospital, Pharmacy

    Services determined that their bar coding strategy had to be able

    to identiy preventable errors by triggering the healthcare provider

    at the point o care to re-evaluate the patient, the medication,the dose and the dosage prior to administration. Following this

    determination, the pharmacy was set to identiy the ollowing:

    Its preerred bar code;

    How bar codes could be a xed to each o its medications as a

    unit dose entity;

    How medications are provided to the nurse; and

    How the bar coded medication is administered to the patient.

    In the absence o a national standard or a bar code strategy in

    healthcare, Pharmacy Services developed its own criteria or a

    bar coding solution. The criteria included ensuring that the barcode would be unique, specic and static, enabling Pharmacy

    Services to identiy the pharmaceutical product at every level

    o packaging. This endeavor included strong collaboration with

    internal and external stakeholders in order to arrive at the right

    bar code strategy.

    The only solution that met all o the criteria was the GS1

    standard GTIN.

    The GTIN

    North York General Hospital, Pharmacy Services rst approached

    GS1 Canada or additional inormation on the Universal Product

    Code (UPC) in the later part o 2005. There were just a handul

    o GS1 Canada members at this time in the hospital sector,

    meaning the GTIN was not leveraged beyond the point o the

    manuacturer and thereore placing a lot o responsibility on

    hospital pharmacies to efectively track and trace their products.

    Pharmacies, specically hospital pharmacies, ace the challenge o

    managing the organization o medications received in bulk. For

    example, hospital pharmacies will obtain medication packages

    containing 100 doses and the only bar code that appears is placed

    on the secondary packaging (e.g. the container). The hospital

    pharmacy is thereore obligated to repackage each unit dose

    within that larger package, repackaging each dose with a hospital-

    generated, bar code identier.

    Following the determination that the GTIN was the hospitals

    preerred standard, North York General Hospital, Pharmacy

    Services prepared a spreadsheet that contained all o thediferent pharmaceutical manuacturers rom whom they

    purchased medications. From there, the pharmacy determined

    which manuacturers were already using the GTIN and which

    were not.

    With 2200 medication types on the hospitals ormulary, and

    only a small percentage o those containing a unit dose GTIN bar

    code at the time, the pharmacy along with every other hospital

    pharmacy in Canada aced a lot o work in regards to tracking

    and tracing its medications saely and efectively.

    The bar coding strategy: The process

    In order to meet the needs o the hospital and ensure that each

    medication unit dose could be tracked and traced to support

    the hospitals commitment to a culture o patient saety, the

    North York General Hospital, Pharmacy Services developed the

    ollowing processes as part o its strategy in order to identiy

    each unit dose with a bar code.

    Point o procurement

    When a ormulary medication comes into Pharmacy Services

    locale, it is recorded on the previously mentioned spreadsheet

    whereby each pharmaceutical manuacturer is noted as beingGS1 GTIN-compliant or not.

    Automating the medication use process:

    North York General Hospital Pharmacy Services

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    21/56

    192010/2011 GS1 Healthcare Reerence Book

    Virtually all pharmaceutical (Rx) and OTC products are marked

    with a GTIN at the bulk level, as well as those medications that

    come into Pharmacy Services already packaged as unit doses or

    patients. Products at patient-level that are administered in the

    manuacturers original packaging or that are stocked at nursing

    stations are also identied with GTINs.

    However, or those products a part o bulk medication shipments

    requiring repackaging as unit doses, a proprietary bar code is

    a xed as an identier until all hospital suppliers become GS1

    GTIN compliant.

    A xing bar codes to unit doses

    It is crucial or the inrastructure o a hospital pharmacy matches

    its medication-use process which means that a hospitals

    already stringent budget needs to be stretched to meet thenecessary requirements that come with implementing a bar

    coding strategy.

    North York General Hospital thereore purchased an automated

    repackaging machine to provide unit dose dispensing

    removing manual processes to help Pharmacy Services realise

    operational e ciencies with unit dose packaging, as well as

    prevent potential errors that occur by prepackaging medications.

    The capital or this system is extensive priced at approximately

    $300,000CAD.

    In order to a x proprietary bar codes to those unit dosepackages that the hospital creates via its automated repackager,

    a bar coding station was established by purchasing a machine

    that would create and generate bar codes this system is

    approximately $30,000CAD. With the bar coding station, North

    York General Hospital Pharmacy is enabled to input bar code

    numbers and print of bar code labels to be a xed to unit doses.

    Bar coding station, including test scanner

    As an added layer o saety, medications identied with either

    a GTIN or proprietary bar code are validated at the bar codingstation beore being added to the pharmacys inventory. The

    pharmacy retains a hand-held device that tests unit dose bar

    codes to ensure they are identiable and readable, thereby

    preventing them rom being rejected when they are scanned at

    the point o administration.

    Testing bar codes

    Only ater a unit dose is bar coded and tested can it make its way

    into inventory or eventual administration to a patient.

    Cost savings

    Despite the costs, North York General Hospitals executive

    committee supported the hospital pharmacys proposal to

    purchase the above systems and implement the bar codingprocesses proposed a direct reection o the hospitals

    dedication to patient saety. This encouraging decision was

    largely due to Pharmacy Services awareness presentation, given

    to the hospital executive committee in 2005 to identiy areas

    o breakdown leading to medication errors and highlighting

    errors occurring at the point o administration. Through

    this presentation, the hospital pharmacy enhanced overall

    knowledge internally and leveraged executive support to

    proactively prevent errors.

    As a result, the bar coding station and automated repackager

    have already enabled North York General Hospital to realize

    a cost savings o 7-8% each year in terms o its medicationpurchasing and packaging activities.

    Mandating the GTIN

    With the hospitals executive support, a logical next step would

    be to attain support rom the supplier community to assist all

    Canadian hospitals to wholly implement the GS1 standard GTIN,

    which would enable interoperability on a national scale and

    remove the need to a x proprietar y bar codes to medication

    unit doses.

    North York General Hospital, Pharmacy Services has unarguablyidentied the need to include GS1 bar code adoption as a

    actor when procurement groups are evaluating drug products

    Automating the medication use process:

    North York General Hospital Pharmacy Services

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    22/56

    20 2010/2011 GS1 Healthcare Reerence Book

    during the contract process. However, individual hospitals are

    not in a position to mandate bar coding standards; this is a

    government decision.

    To this end, GS1 Canada is collaborating with leading

    Canadianpharmacy supply chain stakeholders, the Institute

    or Sae Medication Practices (ISMP Canada) and the Canadian

    Patient Saety Institute (CPSI), having launched a national projectto promote automated drug identication in Canada using global

    GS1 bar coding standards. The goal o both ISMP Canada and

    CPSI, along with all healthcare partners, is to reduce preventable

    medication errors afecting patients in both institutional and

    community settings. The collaborative eforts o ISMP Canada,

    CPSI, GS1 Canada and healthcare industry stakeholders resulted

    in a national consensus in 2010 to use GS1 bar codes as the

    standard ormat or labeling medication packaging in Canada.

    Next steps

    Approximately our years have passed since the North York

    General Hospital, Pharmacy Services began taking steps toaugment its medication-use processes and improve patient

    saety at the point o care. The hospital pharmacys bar coding

    strategy will o cially roll-out to all hospital departments in early

    November o 2010, when anticipated additional benets and

    cost savings will be realized.

    Due to the anticipated success o this initial undertaking, the

    hospital pharmacy is moving orward with implementing bar

    coding strategies or all medication dosage orms, including oral,

    injectibles, topical, and other dosage orms dispensed through

    North York General Hospital, Pharmacy Services. In addition,

    Pharmacy Services has also engaged in discussions with GS1Canada to leverage additional GS1 standards in the uture, namely

    the GS1 Company Prex Licence. A Prex will enable the pharmacy

    ABOUT THE AUTHORDoris Nessim has over 15 years o experience in

    healthcare and pharmacy leadership positions, including

    project management in implementing healthcare

    technologies, as well as pharmacy practice, education and

    research experience.

    Currently, Ms. Nessim is the Director o Pharmacy Servicesat North York General Hospital, a large community

    teaching hospital located in Toronto, Ontario, Canada. In

    addition to providing overall strategic leadership, scal

    planning, and managing acute and ambulatory care

    pharmacy services, Ms. Nessims visionary leadership is

    advancing sae medication practices at each stage o the

    medication use process.

    Ms. Nessim received her MA in Higher Education rom

    the Ontario Institute or Studies in Education, University

    o Toronto, and is a graduate o the Faculty o Pharmacy,

    University o Toronto. She completed her residency inHospital Pharmacy Practice at Toronto General Hospital.

    Automating the medication use process:

    North York General Hospital Pharmacy Services

    to create GS1-compliant bar codes, streamlining their bar coding

    process by removing the need or proprietary identiers.

    Today, there is increasing momentum in the Canadian healthcare

    sector to reach consensus on business processes that support GS1

    standards. With collaborative eforts and community management

    initiatives, such as North York General Hospitals representation

    on the GS1 Canada Healthcare Pharmacy Sector Board multipleindustry sectors across Canada are working together to make

    enhanced patient saety a reality with critical mass adoption o a

    standardized and automated medication use process.

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    23/56

    212010/2011 GS1 Healthcare Reerence Book

    Keeping an eye on the big picture:

    Mayo Clinics integrated supply chain

    management

    Here a system, there a system:piecing it all together

    Mayo Clinic has in place many systems and processes that help

    its healthcare proessionals understand, manage and track the

    movement o medical products throughout its acilities. Mayohas an Electronic Medical Record system and to support our

    business unctions, such as human resources, accounting and

    supply chain management, we use an Enterprise Resource

    Planning (ERP) system. Mayo has also developed its own

    sotware to manage supplies at the point o patient care that we

    call SIMS (Surgery Inormation Management System, although

    use is beyond surgeries).

    The ERP system contains the source data or suppliers, products

    and pricing or the entire enterprise. SIMS contains an item

    master le or point-o-care sites within our hospitals, including

    the operating room (OR), Catheter Lab, Interventional Radiology

    (IR) and Gastroenterology (GI). These SIMS les are synchronizedwith our ERP system, mainly using the product item number

    stored in the materials management module. Integration

    between SIMS and the ERP has been built (both process and

    automation) over the past 10 years. Our integration with the

    revenue cycle (billing) has evolved similarly and it, too, utilizes

    the ERP Item number in the Charge Master.

    As we work diligently to cut costs while delivering high quality

    patient care, a ocus area or us has been the OR. We use an

    automated physician preerence card system, which helps to

    automate the unctions o the OR. Preerence cards make it easier

    or nurses to provide the correct supplies and equipment or eachsurgery, reducing the number o supplies opened unnecessarily.

    Preerence cards also help in streamlining the billing process,

    limiting mistakes and making the entire process more e cient.

    With our SIMS system, we scan and document exceptions that are

    not on the preerence card or items that require serial tracking.

    The goal is to make everything as simple as possible or those

    doing the scanning, in most cases our nurses. All items arrive in

    the OR (rom our centralized OR Inventory Core) with a barcode orscanning. For supplies, approximately 30% o barcodes need to be

    created in house and 70% can be scanned exactly as they arrive

    rom the vendor. We also use grocery style bar-coded catalogues

    or items that are not practical to barcode.

    For implants, all items must have an internally generated

    barcode, because the vendors currently lack standardized

    barcodes which can be used or this purpose. The barcode or

    ByJoe Dudas,

    Director o Accounting

    and Supply Chain

    Inormatics, Mayo Clinic

    ABSTRACTThe U.S. supply chain has advanced in other industries (retail, grocery, general merchandise),

    but the healthcare industry as a whole is just now learning the benets o electronic commerce,

    vendor-managed inventory (consignment), evaluated receipts settlement, and just-in-time

    replenishment. Some suggest the primary reason we struggle in healthcare is due to the lack o a

    solid, underlying inrastructure, one that acilitates the integration o the supply chain with clinical

    systems through interaces and data standards. For one Integrated Delivery Network (IDN), Mayo

    Clinic, integration is beginning to show the promised benets and allowing the industry to nally

    see the big picture the role data standards play in improving supply chain perormance.

  • 8/8/2019 GS1 Healthcare Reference Book 2010-2011

    24/56

    22 2010/2011 GS1 Healthcare Reerence Book

    Keeping an eye on the big picture:

    Mayo Clinics integrated supply chain management

    implants is generated internally by entering the serial number,

    lot number and expiration date. Consigned items and tissue are

    also stored in SIMS. The system has an indicator or consigned

    verses owned items which is reconciled monthly with the

    o cial consignment contracts.

    Using our current system and processes, Mayo has been able

    to obtain accurate data on implant and supply use in the

    OR and other points o care. The data is then used to drive

    standardization and areas o possible expense reduction which

    ultimately leads to higher value or our patients.

    Inormation drives value

    By integrating our supply chain management systems and

    processes with other critical business and clinical unctions

    within the hospital, we have come a long way in terms o drivinge ciencies and gaining insight into our supply use. We are

    employing best practices to accomplish these goals, including:

    Using very ew non-contract items

    Frequently used items, inventory and serially tracked items

    (implants) are all kept on the ERP Item Master le. Non-contract

    supplies can be procured by either adding the item to the le or

    ordering as a special/non-le item. Special/non-le items are

    managed very closely as are any non-contracted purchase. Data

    regarding the use o non-contract items is collated and reviewed

    by a centralized Value Analysis Team or Mayos hospitals.

    When this centralized team sees a particular non-contract itemordered multiple times, they move orward in discussions with

    the hospital(s) that is ordering the non-contract item to better

    understand the item, and to evaluate whether the item should

    be placed on contract. The committee may also research whether

    there are already acceptable substitute products already under

    contract and used in other Mayo acilities. Mayo works very

    collaboratively as a team and we are data driven in our decision

    making (oten using Six Sigma DMAIC (Dene, Measure,

    Analyze, Improve, Control)/Lean as our quality/e ciency

    ramework). We also have been discussing alternative strategies

    pertaining to our Item Master Strategy that would urther close

    gaps and enhance our processes (Called Category Management,

    used in the Retail Industry today) but are only at the beginningstages o scoping and designing.

    Ensuring the accuracy o preerence cards

    With accurate preerence cards, the correct items are pulled

    rom inventory up-ront, items are not wasted, and there is little

    rework on the part o those doing the stocking in returning items

    to the stock room. This level o preerence card accuracy has

    been achieved through multiple avenues.

    There is a team leader or each services preerence cards at

    each hospital. OR nurses maintain electronic communication

    with the team leader, so that items which are incorrectly onor not on the preerence card are easily communicated to

    the Team Leader or updating.

    As supplies are pulled or a given case, they are put into a

    pending mode electronically. The case cart goes into OR. As

    OR staf opens supplies they increment inventory i they are

    not going to use something and decrement inventory i they

    add something. All supplies decremented and incremented

    are done via barcode scanning. Both these tasks are

    completed beore the items used during a surgical procedure

    are nalized and sent to the ERP central back o ce system.

    Once the supplies/implants used are nalized, the implant

    inormation is entered into the patients electronic medical

    record as well.

    As the patient records are being nalized a small subgroup

    that reads surgeon dictations and checks dictations against

    supplies/implants entered into the electronic medical record

    as used. For example, i the dictation shows that hernia with

    mesh procedure was done, mesh shows up in the used

    supply/implant area.

    Managing point-o-care restocking processes to allow

    or right item, timely availability

    Restocking management is a process that eliminates

    overstocking and potential expiration o supplies. It requires

    buy-in on the part o the nurses or rigorous documentation

    o supplies, because i nurses do not scan added supplies, the

    computer system does not know the item needs to be re-

    ordered. The point o use SIMS system is a real-time system that

    eeds the central ERP system. The central ERP system is a batch

    system, which then replenishes supplies when items are noted

    to have dropped below a PAR level (the previously determinedorder point). Cycle counts are done regularly and back-orders are

    monitored and managed daily.

    Collaborating with physicians to reduce one-shot, non-

    contract item ordering

    With input rom key Mayo physician groups, Mayos Supply Chain

    Management and Clinical workgroups gather and collate data

    about contract/non-contract use o implants and supplies and

    report the ndings back to physicians. This process allows the

    physicians to drive toward consolidation o use or both implants

    and supplies. Physicians are interested in providing high quality

    care or the best price or the patients and so engage in this work

    readily. Our Finance department also collates cost per case dataand presents this to the physician groups as well.

    Ensuring that rebates are captured

    Mayos contract management staf enters supply contracts

    into a centrally housed and managed database. Any contracts

    with rebate eatures are set up with a receivable based on the

    payment schedule and assumed amount (based on projections).

    The receivable is then managed closely like any other signicant

    receivable. Disputes are handled through the contracting team i

    there are issues or delinquent payments.

    Ensuring billing is accurate and complete.Cost changes are electronically updated as received and

    authorized into the ERP central les at Mayo. We