MARKET TRENDS Serialization and Track & Trace back-on again - January 2013
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
MARKET TRENDS Serialization and Track & Trace back-on again January 2013
of counterfeit drug products in cifically states that “The adop-
South East Asia. tion and common use of relia-
ble track and trace technology
is feasible in 2007, and would
help secure the integrity of the
In February 2004, the FDA is- drug supply chain by providing
cost the industry approxima- sued a report on ‘Combating an accurate drug ‘pedigree’,
Preface - tely $ 2 billion in the U.S. alo- Counterfeit Drugs’, which which is a secure record docu-
The FDA Guidelines ne and an additional $ 7 billion has triggered significant inte- menting the drug was manu-
has been lost to drug re-impor- rest and activity in the mass factured and distributed under
According to the US Food tation in 2003. The number of serialization of pharmaceuti- safe and secure conditions.”
and Drug Administration FDA counterfeit investigations cal products and, in particu-
(FDA) and the different re- has quadrupled since 2000. lar, Radio-Frequency Identi- Authentication is the ability
ports and consultants to WHO, fication Technology (RFID). to ensure a particular product
in 2010 counterfeit drugs were PSI (Pharmaceutical Security is not counterfeit or adulte-
estimated to generate about Institute) data, show that the In that report the FDA re- rated as well as to determine
$ 75 billion. As a worldwide total number of pharmaceuti- commended a combination of the current status of that pro-
average, more than 10% of cal crime incidents in 2002 was track and trace and product duct, including whether it has
the drug supply is counterfeit 196, rising to 2003 in 2009. In authentication technology expired, been recalled or pre-
and in some countries more 2010, Aline Plancon, Interpol’s to secure the pharmaceutical viously discarded at any pri-
than half the drug supply is Head of the Medical Product supply chain. The report spe- or point in the supply chain.
suspect. Moreover, 50% of Counterfeiting and Pharma-
the drugs sold on the internet ceutical Crimes (MPCPC) of
are believed to be falsified. WHO’s International Medical
Products Anticounterfeiting Ta-
Industry analysts have estima- skforce (IMPACT), confirmed
ted that counterfeit drugs have the seizure of 20 million units
ASEPTIC PROCESSING & FREEZE DRYING SOLUTIONS p. 1For a track, trace and The serialization of phar- recommend the use of Global The GTIN can be used on all layers
authentication program to maceuticals is indeed a topi- Trade Item Number (GTIN) for of the packaging from the prima-
be truly successful the solution cal and pressing theme on the the identification of pharmaceu- ry pack, e.g. blister through to the
pallet.
must offer visibility and protec- pharmaceutical market. Phar- tical products and Serial Ship-
tion from the point of manufac- maceutical manufacturers are ping Container Code (SSCC) Pharmacies and hospitals are in-
ture to sale to the consumer. seeking simpler, more effective, for logistic cases identification. creasingly wanting barcodes on
The ideal solution will not only and affordable ways to combat the unit dose and this will become
ensure the identity, strength counterfeit drugs, protect pa- GS1 is a neutral, not-for-profit more common.
and purity of the drug but also tient safety, and comply with organisation dedicated to the
the quality and efficacy. the new and emerging regula- design and implementation Global manufacturers want to use
the same method of identification
tions. Increasing security me- of global standards, techno-
(GTIN) across all packaging layers
Comprehensive track, trace and asures helps protect patients, logies and solutions to im- and it will be less confusing for he-
authentication solutions will ul- intellectual property, company prove the efficiency of supply alth care providers.
timately reduce patient risk by reputation and revenues. by adding useful information.
giving manufacturers, wholesa- The GS1 Traceability Standard
lers, carriers, pharmacies and defines business rules and minu-
regulators a systematic method mum requirements to be follo-
to detect and control counter- wed when designing and imple-
feiting, drug diversions and menting a traceability system.
product mishandling.
Preface – GS1
The solutions will ultimately
ensure the right product, in
the right place, at the right Appropriate international com-
time, in the right condition. mission (GS1) has defined stan-
dard codifications common for
Mass Serialization; standards
ASEPTIC PROCESSING & FREEZE DRYING SOLUTIONS p. 2According to EFPIA, after the
Preface – positive results of the pilot in Directive
The EFPIA Guidelines Sweden (Sept. 2009 – Feb.
2010), a 2D matrix barco- According to the latest EU Di-
European Federation of Phar- de (called «data matrix ECC rectives (2001/83/CE, 2010/84/
maceutical Industries and As- 200»), can be implemented in EU and 2011/62/EU), Track & Hospital
sociations (EFPIA) welcomes a step-by-step approach (from Trace is to be adopted throu-
the European Commission pro- a batch level to a product le- ghout the whole supply chain
posal on falsified medicinal pro- vel), without requiring a radical of pharmaceutical products.
ducts as an important starting change in European coding sy-
point for measures to tackle the stem, harmonizing it instead. Retailer
problem of counterfeit medicins Wholesale
EFPIA’s recommendations for
in the legitimate supply chain. Production
coding of pharmaceutical pro-
ducts in Europe:
EFPIA strongly recommends a Pharmacy
Data matrix – Coding
common coding system across Raw &
proposal packaging
Europe, with RFID as a possi- material
derived from GS1 standards to be implemented within 36
ble long term solution, but its
Manufacturer Product Code months after Delegated Act. A
technology together with its
(GTIN or NTIN): 14 digits linear bar code is currently used
high costs make it difficult for it 2 January 2013 is the deadline
Unique Serial Number in Belgium, Greece and Italy as
to be implemented. for member States to bring into
(randomized): up to 20 a carrier for the serialization
force the laws, regulations and number of medicinal products:
alpha-numeric characters
administrative provisions ne- here the Directive foresees a 3
Expiry date: 6 digits
cessary to comply with these years more for the implemen-
Batch Number: up to 20
Directives. Safety Features are tation of the safety features.
alpha-numeric character
The UE
ASEPTIC PROCESSING & FREEZE DRYING SOLUTIONS p. 3stem accessed by all relevant The code is printed on the
The technology parties in the supply to ve- product and subsequently
rify the integrated serial num- read by vision and control sy-
TYPE ADVANTAGES DISADVANTAGES ber. Data Matrix Code is a 2D stems, which are produced
LINEAR BARCODES
barcode symbology provi- by numerous worldwide spe-
• Low cost • Large
ding high data density with cialists, such as Sea Vision,
• Readable by most codes to apply to packa ging
scanners in the supply • Not robust to partial error correction (ECC200). Systech, PCE and so forth.
chain today damage
• Must be read with line of
sight
Barcode 2D Code
2D BARCODES
• Low cost • Must be read with line of sight
Information capacity About 20 characters About 4,000 characters
• Small • More complex and costly rea
ders than Linear Barcodes Kind of information Barcode
• Robust to partial damage
Error correction function X
RFID TAGS Readability Fixed position 360°
• Can be read without a • High unit cost
line of sight
• Complex technology Cycle time to apply (by laser) Seconds Miliseconds
• Requires complex and costly
reader technology
Currently, two distinct techno- Most of Pharmaceutical com-
logies have been developed panies identify Mass Seria-
to face this problem: Mass lization with Data Matrix
Serialization and ePedigree, ECC200 codes (2D) on unit
which recall a simpler formu- pack level as the best, chea-
la called “Track and Trace”. pest and easiest method, to-
gether with a database sy- Contains Data Contains Data
ASEPTIC PROCESSING & FREEZE DRYING SOLUTIONS p. 4According to the FDA Prescrip The ePedigree is a record in Generally speaking, measures -Installation of a centrali-
tion Drug Marketing Act (2004) electronic form containing in- have already been taken to zed system to manage the
and the Florida Drug and Co- formation regarding each tran- activate traceability solutions, 2D codes, capable of collec-
smetic Act (2005), any given saction resulting in a change of called Track & Trace, to com- ting and managing data from
prescription drug requires an ownership of the given prescrip- plete and check the process of all the production lines and
electronic pedigree to accom- tion drug, including returns, the pharmaceutical production making them usable for who-
pany/validate drug distribu- thus to show the lineage of the chain, and specifically: lesalers and/or pharmaceutical
tions. drug from the manufacturer labs.
through the current point in the -Installation of a 2D code
drug distribution channel (who- marking system (DataMatri- -Installation of a 2D code
lesaler, re-packager, pharmacy). xECC200) in every packaging verification system for all
line. This system must be ca- packages that certifies the au-
pable of operating in real time. thenticity of the package. This
DRUG MANUFACTURER WHOLESALE DISTRIBUTION RETAIL DISTRIBUTION RETAIL system will be installed at the
CENTER CENTER (PHARMACY, HOSPITAL)
-Installation of a Vision Sy- wholesalers’ facility and/or at
ePEDIGREE DRUG ePEDIGREE DRUG ePEDIGREE DRUG ePEDIGREE DRUG stem in all packaging lines to the pharmaceutical labs.
MANUFACTURER MANUFACTURER MANUFACTURER MANUFACTURER
verify, in real time, whether the
+ WHOLESALE
DISTRIBUTION CENTER
+ WHOLESALE
DISTRIBUTION CENTER
+ WHOLESALE
DISTRIBUTION CENTER
2D code is correct or not.
+ RETAIL
DISTRIBUTION CENTER
+ RETAIL
DISTRIBUTION CENTER -Installation of a softwa-
re operating system, in all
+ RETAIL
packaging lines, capable of pro-
curing, managing and storing
the 2D codes that identify the
packages (cartons).
ASEPTIC PROCESSING & FREEZE DRYING SOLUTIONS p. 5As matter of fact, the ongoing - a harmonized coding and seria-
World market: EFPIA’s initiative to set up an effec-
tive safeguard system against the
lization system across Europe for
greater patient safety;
status quo & future entry of counterfeit medicines in the - a stakeholder governed point-of-
legal supply chain, clearly demon- dispense system for cost-effective-
scenario strate that the European industry is ness;
calling for: a 2D Matrix code on international
standard as unique identifier for
In many countries around the interoperability.
world, governments are working
to approve specific local laws on
this aspect. Despite a unique so-
lution effective world-wide is not
feasable yet, pharmaceutical indu-
stries, effected by huge economic
losses caused by the counterfeit SWEDEN
drugs’ market, keep looking for
measures easy to be implemented,
with a low economic impact. The CHINA
most critical topics are the disagre- CALIFORNIA FRANCE ITALY
ement on the system to be adop- (US)
ted and who is going to pay for it. SOUTH
TURKEY KOREA
For instance, the coding solu-
tion provides an efficient and
INDIA
cost effective method which me-
ets also the EC’s requirements BRAZIL
for pack identification put forth
in the recently adopted Falsified
Medicines Directive (July 2011).
ARGENTINA
ASEPTIC PROCESSING & FREEZE DRYING SOLUTIONS p. 6On March 26, 2010 FDA pro- • October 2010: details on
Focus on: vided the final guidance for Focus on: how model will work; serializa-
California (USA) product serialization, in Brazil tion scheduled to begin in May
which implementation timeli- 2011, with all serialized by the
nes together with data carriers end of 2011.
where not defined and varia- • March 2011: Legislation on
ble data (batch number, expiry hold pending task force review.
date) were not officially reque- • December 2011: Health
sted. authorities (ANVISA) confirms
track & trace model with ANVI-
In June 2012, US lawmakers SA run central database + Bra-
failed to agree on a national zilian Mint labels removal in fa-
plan for tracking medication. vor of 2D data matrix applied to
California has passed its own • January 2009: Brazilian law
FDA is still working on defining pack (incl. product code, batch
law and its ePedigree, set- calls for serialization with 2D
the final system architecture identifier, expiry date and serial
ting the standard for the Uni- Matrix code on security labels
before setting a date for com- number).
ted States. Implementation will (“Drug production and con-
pliance.
be staggered, with completion sumption traceability through
mandated by the end of 2015. electronic capture, storage and
Back
Requirements: transmission of data”).
Back
• For prescription drug only • November 2009: Resolu-
• SGTIN (Serialized Global Tra- tion RDC No 59 gave further
de Item Number) at item level guidance on the requirements.
for prescription products • January 2010: Brazilian Mint
• Aggregated serialization data issued serialized self-adhesive
(unique code from single item labels to be used in tamper evi-
through pallet) dent mode + track and trace
• Transaction ePedigree database to be set up.
ASEPTIC PROCESSING & FREEZE DRYING SOLUTIONS p. 7cancer drugs, anti-HIV medici- Drug Code) + serial number on
Focus on: nes, etc) according to Provision Focus on: primary and secondary packa-
Argentina 3683/2011, Annex 1. China ges up to the pallet with hie-
• Implementation schedule rarchy information. For the mo-
(Provision 3683/2011) ment, applies for drugs listed
Stage 1: from laboratory to in the National Essential Drug
drugstore and from drugstore List (NEDL). Other products ex-
to pharmacy: within December, pected for 2013.
2011
Stage 2: validation system (MA
holder > distributor > drugsto- Back
re > pharmacy/welfare establi-
• April 2011: Resolution shment > patient): within June, • 2008: China’s SFDA (State
435/2011 designed to tackle 2011 Food and Drug Administration)
the issues of counterfeit, sto- calls for serialization on indivi-
len, unlicensed and otherwise dual saleable pharmaceutical
illegal medicines by using 2D Back products by December 2011
datamatrix code on secondary (for drugs sold in the Chinese
medicine packaging, including market as well as the ones ma-
GTIN. Recommendation: indi- nufactured in China).
cation of expiration date and
lot number; application of the • 2010: “Data electronic su-
code also to pallets, bundles pervision code“ to be printed
and cases.Interim measure: on the smallest sales package
linear (GS1-128) barcode or by March 2011.
RFID carrier.Introductory pha-
se for critical products (e.g. • 2011: China NDC (National
ASEPTIC PROCESSING & FREEZE DRYING SOLUTIONS p. 8January 2010: starts to be date and serial number.
Focus on: mandatory the use of phar- Focus on:
South Korea maceuticals bar code labels India July 2012: 1D or 2D barcodes
(“Pharmaceutical Affairs Act for secondary packaging.
Enforcement Rule”).
2012: expiration date and lot January 2013 for primary
number mandatory in bar co- packaging: 2D (GS 1 Data ma-
des for traceability of specified trix) barcodes on medicines at
drugs. strip/vial/bottle level.
2013: expiration date and lot
number mandatory in bar co-
des for traceability prescription Back
July 2000: introduction of bar drugs. • January 2011: India’s Di-
code label regulation. RFID: The Korean Pharmaceu- rectorate General of Foreign
Following, the GTIN in the stan- tical Information Service (KPIS) Trade (DGFT) issued Public
dard KDC (Korea Drug Code) monitors pharma corporations Notice No. 21, mandating uni-
was changed to symbol formats applying RFID (pilot stage of que numbers and barcodes for
such as EAN-13, GS1-128 and few companies). The Kore- tertiary, secondary and primary
GS1 DataMatrix by the Ministry an government plans to push packaging for all pharmaceuti-
of Health. RFID usage to 50% levels in cals exported from the country.
January 2008: according to the pharmaceutical industry by
the drug standardisation 2015. • Three-phase implementation:
policy, the standard code is to October 2011: 1D bar codes re-
be assigned to every pharma- quired for all tertiary packaging
ceutical product and barcode Back (shipper/carton), encoding uni-
labelling preparation is required que product identification code
at manufacturer/importer level. (GTIN), batch number, expiry
ASEPTIC PROCESSING & FREEZE DRYING SOLUTIONS p. 9• Serial or random codifica-
Focus on: tion on single carton which re- Focus on:
Turkey call a certain group of codes France
matching with the single pro-
duction batch.
2013: web-based program
that allows patients to scan a
drug package’s data matrix to
ensure its validity.
Back
Regulatory implementation AFSSAPS regulation (2011):
January 2010:
• All pharmaceutical products
• with the ITS Project (the Tur- distributed in France must have
kish «Pharmaceuticals Track a 2D Data matrix barcode, in-
and Trace System»), every drug corporating the CIP13 code
unit in Turkey is being tracked (product number), batch num-
and recorded with the Track ber and expiration date at item
and Trace method. Using a level.
2D Data matrix code instead of
formerly used barcode, all the
drugs in the market are tracked Back
on the basis of packages using
keys of GS1 standards.
ASEPTIC PROCESSING & FREEZE DRYING SOLUTIONS p. 10verified before being dispen- • 2007 IMPACT ITALIA:
Focus on: sed, supplied by 14 leading Focus on: Italian task-force that involves
Sweden pharmaceutical companies. Italy the main institutions working to
combat counterfeit medicines.
The pilot demostrated how a
cost-effective serialization and • 2012: UDI (Unique Device
coding system can prevent Identification) regulation under
counterfeit medicines from rea- development.
ching patients.
Back
Back
2010: EFPIA successfully pi- • 2001: application of the Ita-
loted its product verification lian bollino (AIC code – 9 di-
system, started in September gits), supplied by an authorized
2009, in cooperation with the printer designated by the
Swedish pharmaceutical manu- Italian government.
facturers’ association. Unique sequential code.
Product name, ID #, Holder
Project’s features: name.
- application of a 2D Data
matrix code; • 2005: Italian MoH established
- to be run for approximately 4 a central database to track
months; pharmaceutical products.
- 25 pharmacies involved;
95.000 packs scanned and
ASEPTIC PROCESSING & FREEZE DRYING SOLUTIONS p. 11You can also read
