Purdue Pharma Combats Counterfeiting and Diversion with RFID. Harry Ramsey Sr. Package Development Engineer Purdue Pharma L.P.

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3 Purdue Pharma Combats Counterfeiting and Diversion with RFID Harry Ramsey Sr. Package Development Engineer Purdue Pharma L.P.

4 Purdue Pharma L.P. Privately held pharmaceutical company Original company founded in 1892 Over the Counter Products Laxatives Nutritional supplements Antiseptics Rx Products Opioid analgesics OxyContin (oxycodone hydrochloride controlled-release) tablets

5 OxyContin Tablets WARNING: OxyContin is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine. Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. OxyContin Tablets are NOT intended for use as a prn analgesic. OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. A single dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids. OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OxyContin TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

6 Purdue Timeline First item-level RFID implementation (Nov. 2004) Update/expansion of original pilot (May 2007) 3 rd party solution implementation (April 2008)

7 Original RFID Pilot (2004) October Wal-Mart Requirement (RFID Guidelines and Requirements for CII Pharmaceuticals) UHF Class 0 (Matrics/Symbol/Motorola) tags used OxyContin 100s bottles tagged at the item-level no case-level tags no aggregation First item-level RFID implementation Limited Lifespan due to upcoming Gen2 UHF technology Largely a bolt-on solution on one packaging line Approximately 300,000 bottles shipped Nov June 2007

8 UHF Class 0 Pilot

9 Lessons Learned (circa 2004) UHF Class 0 had potential but challenges remained Reading 48 tags (and only 48 tags) per case is a challenge A case tag aggregated to the items inside would have been nice to limit the amount of times that full cases needed to be read Tag quality is uneven so prequalification of the tags at label converter is a necessity Pre-writing the chips at the factory presented a logistical nightmare

10 UHF Gen2 Pilot Start-up May 2006 Drivers: Production Gen2 case tags had been on the market for about 1-1/2 years Multiple hardware vendors Prototypical item-level Gen2 tags were beginning to be available from multiple tag suppliers 1.5 years of experience with Class 0 had taught us what improvements were necessary Class 0 technology had a limited lifespan so replacing the initial pilot was inevitable

11 Scope of UHF Gen2 project Select appropriate software vendors Select appropriate hardware vendors Select appropriate Gen2 tag suppliers Make process improvements from initial pilot: Integrate RFID functions into the existing packaging lines Add a case-level tagging and aggregation Improve warehouse processing

12 Decision Drivers Systech software was already running the packaging lines and working well Experienced from most initial RFID pilots in pharma Packaging line software needed upgrading anyway Hardware was determined via a testing matrix that combined multiple hardware vendors with different tags using Systech software Testing occurred over a 2 week period at Systech

13 RFID Testing Results Big Winner: Gen2 UHF Proved it had the potential we were looking for Hardware Selections: Impinj on the packaging line Motorola in the warehouse/distribution center Using multiple tag suppliers appeared feasible

14 RFID Implementation Plan Packaging line layout Distribution center layout System logic operating principles (what happens where and why) Exception handling (what do we do when something unexpected happens?)

15 Gen2 - The Label

16 Labels On Roll

17 Packaging Line Item-level Reader

18 Packaging Line Single Bottle Gen2 RFID Reader Mini antenna reads EPC from each item-level tag on bottle EPC (SGTIN-96): XXXXXXXXXXXX EPC static data must match expected value from recipe Tag must respond within maximum time interval Tag must respond to reader with a received signal strength indication (RSSI) above pre-set minimum System uses failsafe logic all bottles must pass all tests to avoid rejection If bottle isn t rejected, then it is pre-commissioned and continues down the line toward case-level reader

19 Case-level Reader

20 Case-level Reader Screen

21 Case-level Reader

22 Packaging Line Full Case Gen2 RFID Reader Portal reader reads EPCs from 48 item tags & 1 case tag per shipper Bottle EPCs must match expected values read on the bottle reader Case EPC must match value encoded on case tag that is applied to shipper just prior to entering the portal All tags must respond within maximum time interval Tags must respond to portal with a received signal strength indication (RSSI) above pre-set minimums If full case passes all tests, the 48 item tags are aggregated, associated with the case tag, and commissioned Shippers then continue down the line to be palletized

23 Pallet Building

24 Completion of Packaging Once entire lot has completed packaging, operator closes out the lot in the packaging line software Upon close out of lot, all EPCs are transmitted to the database and associated with the lot number Pallets from the lot are taken to warehouse and placed into vault for subsequent release and eventual shipment to customers Order processing to customers occurs in the warehouse where the RFID tags are read one final time before shipment

25 Warehouse Design User Defined Requirements Minimal impact to processing time Significant involvement in process development and testing Integrated Process Original Class 0 RFID = One Conveyor Read Station Gen2 RFID = 2 Mobile Stations and 4 Desktop Stations Mobile Packing Station Desktop Packing Station

26 Gen2 Go Live The first Gen2 tagged lot packaged on May 31, 2007 Original plan was to do a controlled launch for a few partner pilots using one packaging line 2 nd packaging line installation was scheduled to begin approximately 2 months after the first The success of the Gen2 implementation on the first packaging was apparent very quickly after production packaging began.

27 Gen2 Go Live A new plan emerged after 2 weeks of continuous RFID packaging on the first line 2 nd packaging line installation was rescheduled to ASAP Schedules were shifted and installation on 2 nd line was completed well ahead of original plan Since May 31, 2007 every bottle of U.S. OxyContin 100s have been packaged using RFID

28 3 rd Party Problem Problem: Not all Purdue products are packaged at our RFIDenabled plant Contract packagers Secondary Purdue Plant Most Rx Products are shipped out of RFID-enabled DC regardless of where they are packaged Distribution center is the common thread for almost all products applicable to future pedigree requirements How do you reproduce the packaging line RFID capabilities at multiple sites efficiently and cost effectively?

29 3 rd Party Solution All tags come to contract packagers pre-programmed on labels Label/tag supplier guarantees proper EPC encodation per specifications supplied 3 rd party packager has small item-level reader on packaging line to ensure tag is readable (no EPC check only ensures tag isn t dead or weak) Products are bottled, labeled, and case packed as usual (no case-level aggregation, no RFID case tag) Upon completion of packaging and subsequent release at the 3 rd party packager, product is shipped to our RFID-enabled DC where the magic happens

30 3 rd Party Solution Process Cases of all incoming lots are de-palletized and counted per normal procedures Warehouse personnel uses recipe-driven system to print & encode RFID case tags equal to the number of cases in shipment Case tags are hand-applied to each case and then each case is put on conveyor system thorough RFID portal in warehouse RFID portal reads all expected quantity of tags in the case (quantity determined from recipe) + 1 case tag and EPC numbers are checked

31 3 rd Party Solution Process If EPCs and expected quantity match, item-level tags are aggregated to the case tag and case is placed in precommissioned status Once lot has been completely been run through the portal, any exceptions are noted and operator closes out lot in the system Upon close out of lot, all case and items are placed in commissioned status and are ready to be placed in inventory RFID-tagged items whether packaged in-house or not, are read and packed for orders through the normal process

32 3 rd Party Solution

33 RFID Statistics (as of 4/09) Bottles tagged: +7.5 Million Cases tagged: +155,000 Tags rejected on line = 0.072% or 7.2 bottles for every 10,000 Dead Tags found in warehouse = 0.011% or 1.1 bottles for every 10,000 One of lot tagged bottles accounted for 89% of all warehouse rejects - ignoring that one lot: Warehouse Reject rate = % or 1.2 bottles for every 100,000

34 RFID Ongoing Activities Continual improvement initiatives ongoing to streamline current processes and increase efficiency Working with RFID suppliers to increase RFID efficiency and reduce reject rates Investigating potential RFID redundancy initiatives to improve exception handling Experimenting with other dosage forms (liquids, blisters, etc.) for RFID readiness Planning for potential future e-pedigree requirements

35 Questions???

36 rfidjournalevents.com/presentations