gs1 healthcare reference book 2010-2011
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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
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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
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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.
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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
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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.
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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
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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.
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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
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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.
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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.
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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
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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
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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.
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ETCO,GlaxoSmithkline.
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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
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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.
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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.
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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.
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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.
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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
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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
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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.
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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.
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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