Comments on: Will The Pharma Supply Chain Be Able To Use Inference? Maybe Not! http://www.rxtrace.com/2010/06/will-the-pharma-supply-chain-be-able-to-use-inference-maybe-not.html/ A comprehensive exploration of the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance Wed, 16 May 2012 10:37:40 +0000 hourly 1 http://wordpress.org/?v=3.3.2 By: Canice http://www.rxtrace.com/2010/06/will-the-pharma-supply-chain-be-able-to-use-inference-maybe-not.html/comment-page-1/#comment-255 Canice Thu, 17 Jun 2010 10:47:50 +0000 http://www.rxtrace.com/?p=304#comment-255 An alternative to scanning in the 2D code individually on each carton in a case is to use a hi-res camera (like the Congex) to read the 2D codes of all cartons in the case before the case is closed. This increases the confidence that each aggregated carton is physically present in the case. It can also be used in cases with multiple levels of cartons as the lower level is usually visible to the camera before the upper level is 'pushed' in. The main disadvantage is that the 2D code on all cartons in a layer must be visible to the camera, typically this means that the 2D code is on the end of the carton - which may require artwork changes. [Disclosure: I work for a company which develop automated vision inspection products] An alternative to scanning in the 2D code individually on each carton in a case is to use a hi-res camera (like the Congex) to read the 2D codes of all cartons in the case before the case is closed. This increases the confidence that each aggregated carton is physically present in the case. It can also be used in cases with multiple levels of cartons as the lower level is usually visible to the camera before the upper level is ‘pushed’ in.

The main disadvantage is that the 2D code on all cartons in a layer must be visible to the camera, typically this means that the 2D code is on the end of the carton – which may require artwork changes.

[Disclosure: I work for a company which develop automated vision inspection products]

]]> By: Dirk Rodgers http://www.rxtrace.com/2010/06/will-the-pharma-supply-chain-be-able-to-use-inference-maybe-not.html/comment-page-1/#comment-234 Dirk Rodgers Thu, 10 Jun 2010 02:33:58 +0000 http://www.rxtrace.com/?p=304#comment-234 Anonymous, Printing the unit serial numbers contained inside of cases on a label placed on the outside using a (big) 2D barcode may seem like a great idea, but it doesn't really solve the fundamental problem. If the case packer cannot reliably and repeatably determine exactly which units went into which case, having the serial numbers they think are inside the case printed on a barcode outside of the case isn't going to improve the odds that they are right. It is no different than if they had sent you that same information in an ASN or in a pedigree. If the unit-to-case aggrergation is wrong in one form, it would be wrong in any form and the only way to know for sure if it is right or wrong is to open each case and scan the serial number barcode on each unit. Dirk. Anonymous,
Printing the unit serial numbers contained inside of cases on a label placed on the outside using a (big) 2D barcode may seem like a great idea, but it doesn’t really solve the fundamental problem. If the case packer cannot reliably and repeatably determine exactly which units went into which case, having the serial numbers they think are inside the case printed on a barcode outside of the case isn’t going to improve the odds that they are right. It is no different than if they had sent you that same information in an ASN or in a pedigree. If the unit-to-case aggrergation is wrong in one form, it would be wrong in any form and the only way to know for sure if it is right or wrong is to open each case and scan the serial number barcode on each unit.

Dirk.

]]> By: Dirk Rodgers http://www.rxtrace.com/2010/06/will-the-pharma-supply-chain-be-able-to-use-inference-maybe-not.html/comment-page-1/#comment-233 Dirk Rodgers Thu, 10 Jun 2010 02:24:15 +0000 http://www.rxtrace.com/?p=304#comment-233 Davide, Thanks for your excellent point. My comments showed way too much confidence in RFID as an identification technology. I have some experience with UHF EPCglobal Gen2 tags and from that I would guess that you could probably expect to read 100% of the units inside cases of drugs on a conveyor reliably and repeatably in less than 50% of the pharmaceutical SKU's on the market today without first reducing the casepack quantity. Most RFID vendor demonstrations you see at trade shows use either easily read products (dry, non-metallic solids), use UHF near-field magnetic coupling (with no more than a 12-inch conveyor width), or use non-standard, proprietary and costly HF tags (Magellan's demo works pretty well, but is that technology the one that EPCglobal is using in their HF Gen2 standard?). Manufacturers would have to make significant changes to many of their casepacks if RFID were to be adopted for all drugs so that 100% of the units would be readable in a tunnel reader on a conveyor, but I still think it would be possible. Just not with the kind of casepacks we see today on many products. Dirk. Davide,
Thanks for your excellent point. My comments showed way too much confidence in RFID as an identification technology. I have some experience with UHF EPCglobal Gen2 tags and from that I would guess that you could probably expect to read 100% of the units inside cases of drugs on a conveyor reliably and repeatably in less than 50% of the pharmaceutical SKU’s on the market today without first reducing the casepack quantity. Most RFID vendor demonstrations you see at trade shows use either easily read products (dry, non-metallic solids), use UHF near-field magnetic coupling (with no more than a 12-inch conveyor width), or use non-standard, proprietary and costly HF tags (Magellan’s demo works pretty well, but is that technology the one that EPCglobal is using in their HF Gen2 standard?).

Manufacturers would have to make significant changes to many of their casepacks if RFID were to be adopted for all drugs so that 100% of the units would be readable in a tunnel reader on a conveyor, but I still think it would be possible. Just not with the kind of casepacks we see today on many products.

Dirk.

]]> By: Anonymous http://www.rxtrace.com/2010/06/will-the-pharma-supply-chain-be-able-to-use-inference-maybe-not.html/comment-page-1/#comment-231 Anonymous Wed, 09 Jun 2010 18:30:53 +0000 http://www.rxtrace.com/?p=304#comment-231 Dirk, silly question but has anyone considered printing the unit IDs on the case packaging, say using a 2D barcode? Or is that just inference under another name? Dirk, silly question but has anyone considered printing the unit IDs on the case packaging, say using a 2D barcode? Or is that just inference under another name?

]]> By: Davide http://www.rxtrace.com/2010/06/will-the-pharma-supply-chain-be-able-to-use-inference-maybe-not.html/comment-page-1/#comment-229 Davide Wed, 09 Jun 2010 14:21:17 +0000 http://www.rxtrace.com/?p=304#comment-229 Dear Dirk, thank you for your interesting post. Regarding the following statement: "<em>At this point, let’s not forget that if every unit had an RFID tag on it, manufacturers/packagers would simply have to run each case down a conveyor through a tunnel reader after they sealed them and read the serial numbers on the units and on the case at the same time. Voila! You know the unit-to-case aggregation for that case of product. And that technique would be very reliable and repeatable."</em> I am not a technical expert of RFID, but from a few research I have been doing recently on the topic and from recent talks with technical experts in the sector of RFID, I do not know of any RFID system that would realistically perform the task in a way as simple as you describe. I guess that the RFID reader should be able to identify almost with 100% accuracy the items inside the case, and from my limited knowledge of the subject I don't know of any working example of RFID technology that is able to do it with such 100% accuracy, though glass, liquids, aluminum blisters etc. What your opinion on the matter? If you know of any specific commercial TAG / reader combination that would allow to do the "unit-to-case-aggregation" with the above characteristics, please let me know, I would be very interested in it! Thank you again for your interesting post. Regards Davide Dear Dirk,
thank you for your interesting post.
Regarding the following statement:

“At this point, let’s not forget that if every unit had an RFID tag on it, manufacturers/packagers would simply have to run each case down a conveyor through a tunnel reader after they sealed them and read the serial numbers on the units and on the case at the same time. Voila! You know the unit-to-case aggregation for that case of product. And that technique would be very reliable and repeatable.”

I am not a technical expert of RFID, but from a few research I have been doing recently on the topic and from recent talks with technical experts in the sector of RFID, I do not know of any RFID system that would realistically perform the task in a way as simple as you describe.

I guess that the RFID reader should be able to identify almost with 100% accuracy the items inside the case, and from my limited knowledge of the subject I don’t know of any working example of RFID technology that is able to do it with such 100% accuracy, though glass, liquids, aluminum blisters etc.

What your opinion on the matter?
If you know of any specific commercial TAG / reader combination that would allow to do the “unit-to-case-aggregation” with the above characteristics, please let me know, I would be very interested in it!

Thank you again for your interesting post.
Regards

Davide

]]> By: Dirk Rodgers http://www.rxtrace.com/2010/06/will-the-pharma-supply-chain-be-able-to-use-inference-maybe-not.html/comment-page-1/#comment-226 Dirk Rodgers Tue, 08 Jun 2010 07:12:32 +0000 http://www.rxtrace.com/?p=304#comment-226 Anon, Thank you for your comments. Here are my thoughts and comments for each of your numbered considerations. 1. Frankly I don't think this is a fair question. In all of my collaboration with lots of people on anti-counterfeiting I can say that I have never observed anyone who seemed to lack appropriate interest in stopping counterfeiting of drugs. Perhaps that's because the people I collaborate with are often specifically focused on supply chain integrity, but I've also never observed any U.S. supply chain companies that have policies that indicated they are disinterested in stopping the contamination of the legitimate supply chain by criminals. In my observation, all trading partners take an interest in mitigating counterfeiting. However, there are always differences in opinion about exactly what is the right way to accomplish it. 2. I'll agree that some manufacturers have done a good job of barcoding their cases, but certainly not all have. Barcoding of lot numbers on cases was a good start, but without a machine readable lot number on the individual units, full lot tracking through the supply chain is impractical. Perhaps you could make the argument that a 2D barcode on the unit level that contains the GTIN (NDC) plus the lot number but without a serial number, might be almost as valuable as the GTIN plus serial number, but once you go that far are the costs that much lower? 3. This is an excellent question. I have a similar concern that the industry may be forced to add huge costs to the operation of the U.S. supply chain without actually having any positive impact on the problem, small as it is today. My proposed solution is that legislators and regulators should be required to explain exactly what their proposed regulatory requirements are supposed to accomplish and how they would accomplish it. 4. I agree with those who propose that some supply chain members will not make the deadline and some important drugs may not be available to the citizens of California because those companies will simply withhold their products rather than pay a fine. I'm not sure how regulation can prevent that. I'm not sure I understand what you mean that manufacturers will be accountable. I'm confident that any product that does not comply with the California law by the deadline will not be distributed by wholesalers within the state because the wholesalers will not want to pay a fine for doing so. As I read the California regulations, wholesalers and pharmacies would be the only entities that the state could fine. Except perhaps for a manufacturer who ships product directly to a location within California, I don't see any way the state will be able to fine a manufacturer who choses not to serialize and pedigree their product by the deadline. It would be the wholesaler who chooses to distribute unserialized and unpedigreed product after the deadline within the state who would be fined. The manufacturer could plead that they were innocent because they shipped the product to the wholesaler's hub DC located outside of the state and was not responsible for the product showing up in California. 5. I'm familiar with lot-based track and trace through a DC and I can tell you that it is very impractical--let me say, unworkable--in large volumes. Once a mistake occurs that results in the loss of the knowledge of which unit came from where, you can end up with millions of dollars worth of product that cannot be sold. The farther down the supply chain you get the worse the problem becomes. 6. I agree with you here, but I'd say that any kind of traceability system will provide all of these benefits to the pharmacy--except one that is lot-based. 7. I agree that supply chain traceability serial numbers should be linked to Electronic Medical Records (EMR's) (not ePrescribing systems). Perhaps that can be planned for by the EMR folks now that they know what format the serial number will take, thanks to the recent FDA SNI Guidance. (See my essay, "FDA Aligns with GS1 SGTIN For SNDC" at http://www.rxtrace.com/2010/03/fda-aligns-with-gs1-sgtin-for-sndc.html ). Prior to that I suspect these folks wouldn't have known what to include in their databases. 8. I must admit that I'm not familiar with what major changes manufacturers made for sample controls after the PDMA was enacted. But if they were changes made in good faith then they must have been fully voluntary and not as the result of binding regulatory requirements. Did all manufacturers make the same good faith changes? Dirk. Anon,
Thank you for your comments. Here are my thoughts and comments for each of your numbered considerations.

1. Frankly I don’t think this is a fair question. In all of my collaboration with lots of people on anti-counterfeiting I can say that I have never observed anyone who seemed to lack appropriate interest in stopping counterfeiting of drugs. Perhaps that’s because the people I collaborate with are often specifically focused on supply chain integrity, but I’ve also never observed any U.S. supply chain companies that have policies that indicated they are disinterested in stopping the contamination of the legitimate supply chain by criminals. In my observation, all trading partners take an interest in mitigating counterfeiting. However, there are always differences in opinion about exactly what is the right way to accomplish it.
2. I’ll agree that some manufacturers have done a good job of barcoding their cases, but certainly not all have. Barcoding of lot numbers on cases was a good start, but without a machine readable lot number on the individual units, full lot tracking through the supply chain is impractical. Perhaps you could make the argument that a 2D barcode on the unit level that contains the GTIN (NDC) plus the lot number but without a serial number, might be almost as valuable as the GTIN plus serial number, but once you go that far are the costs that much lower?
3. This is an excellent question. I have a similar concern that the industry may be forced to add huge costs to the operation of the U.S. supply chain without actually having any positive impact on the problem, small as it is today. My proposed solution is that legislators and regulators should be required to explain exactly what their proposed regulatory requirements are supposed to accomplish and how they would accomplish it.
4. I agree with those who propose that some supply chain members will not make the deadline and some important drugs may not be available to the citizens of California because those companies will simply withhold their products rather than pay a fine. I’m not sure how regulation can prevent that. I’m not sure I understand what you mean that manufacturers will be accountable. I’m confident that any product that does not comply with the California law by the deadline will not be distributed by wholesalers within the state because the wholesalers will not want to pay a fine for doing so. As I read the California regulations, wholesalers and pharmacies would be the only entities that the state could fine. Except perhaps for a manufacturer who ships product directly to a location within California, I don’t see any way the state will be able to fine a manufacturer who choses not to serialize and pedigree their product by the deadline. It would be the wholesaler who chooses to distribute unserialized and unpedigreed product after the deadline within the state who would be fined. The manufacturer could plead that they were innocent because they shipped the product to the wholesaler’s hub DC located outside of the state and was not responsible for the product showing up in California.
5. I’m familiar with lot-based track and trace through a DC and I can tell you that it is very impractical–let me say, unworkable–in large volumes. Once a mistake occurs that results in the loss of the knowledge of which unit came from where, you can end up with millions of dollars worth of product that cannot be sold. The farther down the supply chain you get the worse the problem becomes.
6. I agree with you here, but I’d say that any kind of traceability system will provide all of these benefits to the pharmacy–except one that is lot-based.
7. I agree that supply chain traceability serial numbers should be linked to Electronic Medical Records (EMR’s) (not ePrescribing systems). Perhaps that can be planned for by the EMR folks now that they know what format the serial number will take, thanks to the recent FDA SNI Guidance. (See my essay, “FDA Aligns with GS1 SGTIN For SNDC” at http://www.rxtrace.com/2010/03/fda-aligns-with-gs1-sgtin-for-sndc.html ). Prior to that I suspect these folks wouldn’t have known what to include in their databases.
8. I must admit that I’m not familiar with what major changes manufacturers made for sample controls after the PDMA was enacted. But if they were changes made in good faith then they must have been fully voluntary and not as the result of binding regulatory requirements. Did all manufacturers make the same good faith changes?

Dirk.

]]> By: Dirk Rodgers http://www.rxtrace.com/2010/06/will-the-pharma-supply-chain-be-able-to-use-inference-maybe-not.html/comment-page-1/#comment-225 Dirk Rodgers Tue, 08 Jun 2010 06:01:04 +0000 http://www.rxtrace.com/?p=304#comment-225 Brian, Thanks for your comments. Authentication at Point Of Dispense (POD) alone (the EFPIA proposed model) is often perceived as the best solution to prevent patients from receiving counterfeit drugs. However, I contend that this approach may actually encourage more counterfeiting rather than stamp it out. That's because with POD alone, there is no way to actually find who is introducing the counterfeits into the supply chain and where, and there is no production of evidence that can be use to prosecute the criminals if they are found. With POD alone, a criminal might be able to introduce counterfeits into the legitimate supply chain, making a bunch of money, then disappear once the product begins to fail authentication. Sure, the patient is protected, but now you really need to rely on that authentication because counterfeits in the supply chain have become more common. It seems to me that it is better not to give up on the integrity of the supply chain but to monitor it throughout to ensure that any introduction of illegitimate product is detected ASAP--preferably before the criminal gets paid--and blocked ASAP, and evidence is automatically generated that can be used to prosecute the criminals...ASAP. For more on this topic, see my essay, What are Pedigree Laws Trying to Accomplish Anyway? http://www.rxtrace.com/2009/11/what-are-us-pedigree-laws-trying-to.html Dirk. Brian,
Thanks for your comments. Authentication at Point Of Dispense (POD) alone (the EFPIA proposed model) is often perceived as the best solution to prevent patients from receiving counterfeit drugs. However, I contend that this approach may actually encourage more counterfeiting rather than stamp it out. That’s because with POD alone, there is no way to actually find who is introducing the counterfeits into the supply chain and where, and there is no production of evidence that can be use to prosecute the criminals if they are found. With POD alone, a criminal might be able to introduce counterfeits into the legitimate supply chain, making a bunch of money, then disappear once the product begins to fail authentication. Sure, the patient is protected, but now you really need to rely on that authentication because counterfeits in the supply chain have become more common. It seems to me that it is better not to give up on the integrity of the supply chain but to monitor it throughout to ensure that any introduction of illegitimate product is detected ASAP–preferably before the criminal gets paid–and blocked ASAP, and evidence is automatically generated that can be used to prosecute the criminals…ASAP.

For more on this topic, see my essay, What are Pedigree Laws Trying to Accomplish Anyway? http://www.rxtrace.com/2009/11/what-are-us-pedigree-laws-trying-to.html

Dirk.

]]> By: Dirk Rodgers http://www.rxtrace.com/2010/06/will-the-pharma-supply-chain-be-able-to-use-inference-maybe-not.html/comment-page-1/#comment-224 Dirk Rodgers Tue, 08 Jun 2010 05:47:52 +0000 http://www.rxtrace.com/?p=304#comment-224 Ali, Thanks for your comments. I'm glad that the costs for automated packaging machines are now lower than they have been in the past due to advancements in reader technology. Notice that it's a whole lot easier for me to refer to costs in relative terms rather than absolute terms. That's partly lazyness and partly because my point is that this is a cost that was not recognized by some people until recently, after it became evident that RFID wasn't going to happen in pharma at the unit level. Even if the costs are lower now, they aren't free. If larger companies haven't included these costs in their budget requests or their long-range plans, it's going to be a real surprise to their upper management when they finally get added. It may not be so bad for smaller companies. Dirk. Ali,
Thanks for your comments. I’m glad that the costs for automated packaging machines are now lower than they have been in the past due to advancements in reader technology. Notice that it’s a whole lot easier for me to refer to costs in relative terms rather than absolute terms. That’s partly lazyness and partly because my point is that this is a cost that was not recognized by some people until recently, after it became evident that RFID wasn’t going to happen in pharma at the unit level. Even if the costs are lower now, they aren’t free. If larger companies haven’t included these costs in their budget requests or their long-range plans, it’s going to be a real surprise to their upper management when they finally get added. It may not be so bad for smaller companies.

Dirk.

]]> By: Dirk Rodgers http://www.rxtrace.com/2010/06/will-the-pharma-supply-chain-be-able-to-use-inference-maybe-not.html/comment-page-1/#comment-223 Dirk Rodgers Tue, 08 Jun 2010 05:40:11 +0000 http://www.rxtrace.com/?p=304#comment-223 Scott, Thanks for your comment. If a manufacturer knows exactly which serial numbers are included in the shipment to their customer, why wouldn't they know which cases they were in? As I understand it, the only way a manufacturer would know this is when the unit serial numbers are contained in barcodes only is if they were using inference on shipment. That is, they would pick the cases that would fulfill their customer's order from their warehouse, read the case serial numbers and then look up the corresponding unit-to-case aggregations that had been stored at the time the cases were packed. I don't know any way for the manufacturer to identify exactly which units they are shipping, but not know exactly which cases the units are in. Dirk. Scott,
Thanks for your comment. If a manufacturer knows exactly which serial numbers are included in the shipment to their customer, why wouldn’t they know which cases they were in? As I understand it, the only way a manufacturer would know this is when the unit serial numbers are contained in barcodes only is if they were using inference on shipment. That is, they would pick the cases that would fulfill their customer’s order from their warehouse, read the case serial numbers and then look up the corresponding unit-to-case aggregations that had been stored at the time the cases were packed. I don’t know any way for the manufacturer to identify exactly which units they are shipping, but not know exactly which cases the units are in.

Dirk.

]]> By: Anon http://www.rxtrace.com/2010/06/will-the-pharma-supply-chain-be-able-to-use-inference-maybe-not.html/comment-page-1/#comment-222 Anon Tue, 08 Jun 2010 04:11:38 +0000 http://www.rxtrace.com/?p=304#comment-222 Dirk, There are a number of other considerations: 1. Which trading partner has the greatest incentive to mitigate counterfeiting? 2. Historically, who adopts and deploys new technology? Most manufacturers have deployed shipper barcodes in late 80's including bar coded lot #'s yet limited use even today. Manufacturers have put bar codes on all levels of packaging to reduce medication errors. Again, marginal adoption though this could save lives! 3. Where do most counterfeit / diverted products enter the market and will these systems address that issue? 4. What is likelihood that all trading partners will be up and running and will this be enforceable(we know the manufacturers will be accountable)? 5. Aren't simplier systems avaliable to facilitate TnT such as lot control and reconciliation. I assume most larger trading partners utilize warehouse management IT systems with lot control capability. Lot control doesn't require reading each unit, it requires location management and equipment feeding procedures. So why hasn't this been adopted as an interim step? 6. Can point of dispense afford other patient safety features such as medication error prevention, expiration date controls, providing timely warnings (recalls, etc). The EFPIA pilot proved some of these benefits with a pharmacist friendly system. 7. Wouldn't it make sense to build functionality into the ePrescribing networks to facilitate these benefits rather than comback at a later time. Could this act as a technology migration path with the 2 most important points in the supply chain on line first? 8. One lesson from 1988 PDMA is that manufacturers do make major changes in their systems, most notably sample controls. Have we seen the same good faith put forth elsewhere. As I read Dangerous Doses, a line from Shakespeare comes to mind-"doth protest too much". Dirk,
There are a number of other considerations:
1. Which trading partner has the greatest incentive to mitigate counterfeiting?
2. Historically, who adopts and deploys new technology?
Most manufacturers have deployed shipper barcodes in late 80′s including bar coded lot #’s yet limited use even today.
Manufacturers have put bar codes on all levels of packaging to reduce medication errors. Again, marginal adoption though this could save lives!
3. Where do most counterfeit / diverted products enter the market and will these systems address that issue?
4. What is likelihood that all trading partners will be up and running and will this be enforceable(we know the manufacturers will be accountable)?
5. Aren’t simplier systems avaliable to facilitate TnT such as lot control and reconciliation. I assume most larger trading partners utilize warehouse management IT systems with lot control capability. Lot control doesn’t require reading each unit, it requires location management and equipment feeding procedures. So why hasn’t this been adopted as an interim step?
6. Can point of dispense afford other patient safety features such as medication error prevention, expiration date controls, providing timely warnings (recalls, etc). The EFPIA pilot proved some of these benefits with a pharmacist friendly system.
7. Wouldn’t it make sense to build functionality into the ePrescribing networks to facilitate these benefits rather than comback at a later time. Could this act as a technology migration path with the 2 most important points in the supply chain on line first?
8. One lesson from 1988 PDMA is that manufacturers do make major changes in their systems, most notably sample controls. Have we seen the same good faith put forth elsewhere.

As I read Dangerous Doses, a line from Shakespeare comes to mind-”doth protest too much”.

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