Track & trace in the pharmaceutical industry. Sébastien Mauel Head of Product Security

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1 Track & trace in the pharmaceutical industry Sébastien Mauel Head of Product Security

2 Table of contents Track and trace in the pharmaceutical industry 1. The Merck Serono solution 2. The EFPIA pilot project current status 2

3 The 3 protection principles today INCREASED PROTECTION IDENTIFICATION using standard and harmonized coding systems for secondary packs of pharmaceuticals AUTHENTICATION of the product using overt and covert features INTEGRITY of the original packaging through the entire supply chain using tamper-evidence on each pack 3

4 Track and trace, pedigree INCREASED PROTECTION IDENTIFICATION using standard and harmonized coding systems for secondary packs of pharmaceuticals AUTHENTICATION of the product using overt and covert features INTEGRITY of the original packaging through the entire supply chain using tamper-evidence on each pack 4

5 Table of contents Track & Trace in the pharmaceutical industry 1. The Merck Serono solution 2. The EFPIA pilot project current status 5

6 The Merck Serono track and trace solution History and principles Problems encountered with distribution of Serostim (growth hormone) in the USA: Reimbursement fraud Black market Serostim Secured Distribution Program Introduced in 2003 Individual identification of boxes with serial number Batch KF352 Box nr Batch KF352 Box nr Batch KF352 Box nr Product distribution in selected pharmacies only Verification of the product authenticity prior to dispensing 6

7 The Merck Serono track and trace solution Serostim Secured Distribution Program Pharmacy Manufacturing sites Verification ? Dispensing EMD Serono HQ US Distributor Clearance center

8 The Merck Serono track and trace solution Upgrade to 2D matrix for e-pedigree A project was launched in 2007 to upgrade the system to comply with the expected 2009 Californian requirements: development of a new packaging solution to accommodate the serial number and 2D DataMatrix bar code development of an event tracking system identification of a pedigree vendor development of the pedigree solution including license verification/ validation and integration with 3PLs Current limitations Limited to small volumes, very heavy for large volume products Serial nr is has 7 digits only - not sufficient for future expansion Serial nrs generation history is not in-house 8

9 The Merck Serono track and trace solution 2D matrix / e-pedigree Serial numbers generation Datamatrixes printing Serial numbers recording Upload in a central database E-pedigree generation 9

10 The Merck Serono track and trace solution 1 The packaging material supplier provides boxes bearing a unique and randomized serial number 10

11 The Merck Serono track and trace solution 2 All packaging lines are equipped with fix and mobile readers 11

12 The Merck Serono track and trace solution 3 The operator downloads batch information (item code, variable data, etc.) from the ERP to the local system 12

13 The Merck Serono track and trace solution 4 Serial numbers are recorded at the end of the packaging operations 13

14 The Merck Serono track and trace solution 5 Software checks uniqueness of serial numbers and builds hierarchy from items to shipper cases

15 The Merck Serono track and trace solution 6 Full shipper cases are identified 15

16 The Merck Serono track and trace solution 7 Finally, the data is uploaded in the central repository and made available for the secured distribution program. 16

17 Benefits of the solution Protects patients through improved product security Improves customer confidence: physician, pharmacist, and patient Helps law enforcement combat drug counterfeiting Prepares company to meet regulatory compliance requirements Helps company gain greater insight into demand patterns and inventory management. 17

18 Table of contents Track & Trace in the pharmaceutical industry 1. The Merck Serono solution 2. The EFPIA pilot project current status 18

19 Project goal Patient safety is the primary objective Reduce the risk of counterfeited products being dispensed Automatically detect expired products Achieve more efficient product recalls Reduce dispensing errors with e-prescription Enhance reimbursement processes 19

20 Proposed EU Directive on counterfeit medicines - EFPIA interpretation Prescription medicines will require: a) Tamper-evident closures on each pack b) Authentication features c) Individually identified packs Risk assessment LOWER RISK a HIGH RISK a + b + c Mass serialization in Europe will be a reality over the next 5 years Needs a unique standard to ensure the system is efficient and cost effective 20

21 EFPIA Recommendation for Coding of Pharmaceutical Products in Europe Data Matrix Coding proposal derived from GS1 standards Manufacturer Product Code (GTIN/EAN14 or pseudo-gtin] 14 digits Expiry Date 6 digits (YYMMDD) Batch Number up to 20 alpha-numeric characters Unique Randomized Serial Number up to 20 alpha-numeric characters Example: GTIN: (01) Batch: (10) TEST5632 Expiry: (17) S/N: (21) Specifications provided in EFPIA s European Pack Coding Guidelines 21

22 EFPIA Concept: Product and data flow Pharma Manufacturer Distributor Wholesaler Pharmacist/ Hospital Patient Product Flow Unique Serialization Verification at point of Dispensing 2D Data Matrix on 2 pack Data Transfer Product Serialization Database 22

23 How does the EFPIA product verification solution work? The system compares the information printed on the pack with the information uploaded in the central database by the manufacturer, and confirms that: a) Product record exists and matches with data printed on pack b) Product record has not been previously marked as dispensed c) Product record does not contain any warnings or advisory notices (such as recalled, expired, etc). 23

24 The pilot experiment EFPIA is conducting a pilot project in cooperation with pharmacists in Sweden, with the objective to demonstrate that the proposal is in line with the EC directive on counterfeit medicines is a practical and effective solution for manufacturers, pharmacists, and wholesalers can be fully integrated into the existing operations is based on common standards and a mature technology results in high performance and state-of-the art systems security is a credible alternative to national systems 24

25 Pilot project overview Key figures started months duration 25 pharmacies in the greater Stockholm area, with a total of 180 dispensing points 25 SKUs from 14 different manufacturers 110,000 packs to be verified 25

26 Screen example 26

27 Conclusion Product verification at the point of dispense is an ambitious and long term project which will improve supply chain security and patient safety requires strong governance structure to define e.g. cost split between key stakeholders, data ownership EFPIA proposes an approach that is based on cooperation with key stakeholders based on open standards realistic, interoperable, efficient, and cost effective flexible for future extension 27

28 Thank you for your attention 28

29 Back-up slides 29

30 The Merck Serono track and trace solution System architecture Client application Central repository e-pedigree system Client application Server ERP system Client application Local database 30

31 California requirements Definition: Pedigree Section 4034 (a) "Pedigree" means a record in electronic form, containing information regarding each transaction resulting in a change of ownership of a given dangerous drug, from sale by a manufacturer, through acquisition and sale by one or more wholesalers, manufacturers, repackagers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering, or dispensing the dangerous drug. Recorded in pedigree Recorded in pedigree Recorded in pedigree Recorded in pedigree Manufacturer Distributor Wholesaler Wholesaler Pharmacy Patient 31

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