Blue Sphere Health

Posts Tagged ‘European Union’

Help, we’ve been counterfeited !

We hope your products remain safe, or at least that you have proactive brand protection and a strategy for when things go wrong. Unfortunately, experience tells us that some of you are “winging it”. Just because you haven’t found fakes yet doesn’t mean they aren’t there. It is much safer (for patients as well as your career) to plan for the possibility of counterfeiting than to do nothing and react only if and when it happens.

Ignorance is no excuse

The “do nothing” strategy is about to get even more dangerous, as regulators’ reporting expectations increase. Hidden deep in the EU Falsified Medicines Directive (Article 18, actually) is the phrase: “Where a manufacturer has reason to believe that the … product may not be authentic [he] shall immediately inform the relevant competent authorities” In the US Drug Supply Chain Security Act there are several requirements to file reports on suspect products within one business day – whether the trigger is a request from authorities or an incident identified by the stakeholder.

Don’t use Excel and duct tape

Collating, approving and filing something so business critical within 24 hours is a demanding task. It requires a software system, not crossed fingers and a spreadsheet. Serialisation software won’t solve this problem either, because those systems are designed to handle numbers, not case reports and the other disparate elements of counterfeit surveillance and incident management. If you believe your “suspect product reporting” process is not fit for purpose, we can help. Our Knowledge Capture™ software was developed by our technology partner Integritie and optimised for pharma with our help. It provides litigation-grade tools to support your brand protection function. You may not have a large team but you can have a wide reach with Knowledge Capture. Contact us today to arrange a demonstration.
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Epic DSCSA / FMD Fail: the apology memo to your boss

In the spirit of public service to the pharmaceutical industry as it gears up for the implementation of various traceability requirements, we are offering a free template email for late adopters. Pull this out and use it if you ever have to own up to getting serialisation really, really wrong. (NB we use the European spelling on this site but please mentally replace the middle s with a z if that bothers you). We hope you never need this email, but if you’re going to wait until next year before doing anything or talking to vendors, you might want to file this post in Favourites for re-use later.

Date: sometime in 2017

To: CEO, Pharmacorp Inc.
From: COO / Chief Compliance Officer / Head of Regulatory / SVP Manufacturing / Head of Supply Chain / Head of Technical Operations / whatever
Dear Boss
Thanks for the copy of the Drug Supply Chain Security Act / Falsified Medicines Directive and your refreshingly to-the-point enquiry about our current readiness status for “the [expletive deleted] pack coding deadlines which are only months away”. As of today, I have to admit that I don’t know if our production people will be able to get everything ready in time.
We thought it was a bluff
To your point, we have certainly been aware since 2013 (and in fact years before) of the requirement to mark packs and I agree that three years of preparation seems like an adequate amount of time to get things done. However, we were hoping that either Congress / the EU was kidding or that delays and enforcement holidays would kick this can a long way down the road. I suppose with the benefit of hindsight this may indeed look somewhat “incompetent”.
We need more cash
We have now contacted all the suitable technology vendors and serialisation consultants but it seems that their lead times may be longer than we had hoped. Apparently there is a finite availability of expert resources and the first choice partners are all maxed out with existing customers who are further down the track in preparing for the deadline. Our calculation that we could save money by waiting as long as possible and letting other people make all the mistakes now looks like it may have been wrong. We may have to revisit our budget request to ask for emergency funds to get this done.
We may not be able to sell product
You asked whether missing the deadline would have an impact on our commercial operations. After enquiring with the sales division (thanks for the introduction, by the way) it turns out that the USA and EU are our largest markets – who knew? As I understand it, we can’t sell product there if we don’t meet the legal criteria, so I guess this will have an impact on the financials at some stage. I would recommend holding a slot on the agenda at the next earnings call. If it helps at all, the delay in initiating our program means that some of the capex for equipment spend might be pushed into the next financial year. We hope to be fully compliant again as soon as we get all the process mapping done, user requirement specifications written, vendors selected and contracts finalised, necessary pilots completed, equipment installed on all lines, errors minimised and OEE brought back into line, supply chain partners up to speed, serialised and aggregated inventory flushed through distribution channels etc.
It’s everywhere
FYI, I am also hearing that the DSCSA and FMD may have parallels in other geographies. This may have some other impacts on our Rest of World operations. Our contract manufacturers are in various states of readiness and we may need to revisit key supply arrangements. As soon as I get to grips with what the requirement for serialisation and tamper-evidence means for our global manufacturing strategy I will report back.
I’ll get my coat…
Apologies once again for being caught out by this deadline creeping up on us so suddenly – after all this time. Thanks for your understanding and good luck with explaining the situation at the Board meeting.
Yours, etc.
 

Don’t be that person. Make sure you plan for serialisation, aggregation and tamper-evidence. If you are planning pack changes, bear in mind that all unit-of-sale packs will need to be tamper-evident in the EU by February 2019. Make allowance for strategic advice and implementation consultancy. Don’t try to wing it. This really is the last chance to get things done right and in time. Whether you are just starting, well advanced but need some help along the way, or almost done but just need a little extra resource for fine tuning, we can help. Contact us: [email protected]

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Pharmacy Broadband: EU Serialization’s Biggest Challenge?

The debate on serialization and the implementation of the Falsified Medicines Directive in Europe has tended to focus on the upstream tasks. Implementation of the pack coding, data sharing and tamper-evidence requirements will be a considerable burden on individual manufacturers and repackagers. Designing and building the central infrastructure needed to link systems together into national, regional and EU-wide architecture will also be difficult. Less attention has focused on the other end of the supply chain, at the pharmacy. Previous studies, most notably the pilot carried out by EFPIA in Sweden have been in tightly controlled environments. All of the EFPIA pharmacies were in metropolitan Stockholm, owned by the same entity, with existing broadband internet connections and pharmacists familiar with online working and Sweden’s ubiquitous e-prescription system. This is not to belittle the achievement of the multi-stakeholder team or negate the outputs of the pilot project, but to point out that the environment was about as optimal for success as possible. Now fast-forward two years and EFPIA is conducting its procurement process for a full-scale roll-out of this system across Europe. The full Request-For-Proposal has not, at the time of writing, been released. However, the initial scope diagram below (click diagram for larger image) shows that the project will provide an interface to pharmacy systems but does not deal with the implementation task itself. To make a traceability system secure, it is important to have rapid and universal take-up. This may be delayed by factors outside central control and one of the key issues might be broadband access. This is quite variable, as shown below for general public access. (Data from Eurostat via Google, refresh page if graph not visible.) The broadband penetration for general practitioner surgeries and pharmacies (see below) is a bit higher, as you would expect, but is still nowhere near 100% in many countries. The GP data is given as a proxy for the less complete pharmacy data set which does not cover some countries. Pharmacy data below (click diagram for larger image) are from the Pharmaceutical Group of the European Union (PGEU, personal communication) and GP data are from the EU e-Health Strategies Study published in 2011 (data points collated by Blue Sphere from individual country reports). Some of the individual data points are probably inaccurate, and the correlation between GP and pharmacy broadband usage is not consistent, but the overall theme is pretty clear. There are many countries in Europe where the medical profession is not fully online. The first serialization issue that needs to be addressed may be connecting pharmacies to the outside world in real time. EU broadband access may be variable, but trade barriers aren’t. Pharmaceuticals can be bought anywhere in the EU and sold anywhere else provided the seller makes the necessary pack and leaflet alterations to accommodate local requirements at the destination. The traceability systems which have been discussed to date rely on databases, whether national or EU-wide, to check dispensed serial numbers against uploaded data from manufacturers. For this checking process to be worthwhile, it needs to be at or before the point of dispensing the drug to the patient. Relying on offline verification at point-of-sale with periodic database reconciliation is not a feasible option. In the case of a suspicious event coming to light during the subsequent check, tracking down people hours or days after they received their medication may not be possible and is not safe as they may already have ingested a potentially dangerous counterfeit. Inbound inventory management (checking codes when stock is received rather than when it is dispensed) may reduce the risk but is still not a perfect answer. All the broadband implementation trends are in the right direction, and the issue will start to resolve over time, but to get moving quickly those late-adopters will need help. Those commissioning the prospective EU systems – whether it is EFPIA, EDQM, or the EU itself – will need to address this very local and time-consuming issue of getting pharmacists online as well as dealing with the big-picture IT procurement process. The vendors who are being asked to provide, implement and run the EU system(s) will want some clarity on the extent of their business opportunity and the potential risks and barriers to implementation. Pharmacists may demand financial and practical assistance as part of their agreement to participate. This cost should not fall on manufacturers, who are already paying their own manufacturing change costs plus underwriting the central architecture, but my instinct is that the EU will have to find significant budget from somewhere to make the Falsified Medicines Directive a reality in all its 27 member states. Leave a comment below or contact me at mark(dot)davison(at)bluespherehealth(dot)com
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Drug Industry Plans for European Serialization & Traceability System

The adoption by the European Union of the Falsified Medicines Directive (FMD) last year brought some new clarity and impetus to pharmaceutical anti-counterfeiting. However, some of the concepts – most notably the “safety feature” or code which must be carried by all prescription drugs packs – were left with details unresolved. A Delegated Act process is now in place during which Brussels bureaucrats will put flesh on the bare bones of the FMD. In particular, the infrastructure and systems needed for the coding, tracking and verification of safety features will need some careful thought and detailed impact assessment. Although the Delegated Act itself is not expected to be published for at least another eighteen months, the picture of the EU’s future drug traceability landscape has just drawn into sharper focus. A group of interested parties including the European Federation of Pharmaceutical Industries and Association (EFPIA) has released their vision of how a system might work. This takes the form of a Request for Information (RFI) posted on their website on 5 April 2012. Intended to allow vendors to study the requirements and submit their bona fides, the plan gives some interesting clues about how our medicines might be tracked in the future. EFPIA is the drug industry’s trade association on this side of the Atlantic, representing drug makers large and small, and has a well organised political lobbying capability. They also represent the stakeholder group that the FMD specifically says will have to foot the bill for the EU traceability system. Any system that has the buy-in and backing and backing of the manufacturers will be much more likely to fly than something imposed from Brussels. The manufacturers have also carefully built a consensus with wholesalers, repackagers and pharmacists to present a united front to the legislators. So the EFPIA-backed technical blueprint just released will become the de facto system architecture, in my view. With that in mind, what does the new document tell us about the serialization plans? It was always unlikely that epedigree would be the model in Europe, and not surprisingly EFPIA kicks this possibility firmly into touch. This follows a trend in the USA, where the Pharmaceutical Distribution Security Alliance made a similar case to Congress recently. The RFI documents show a minimal central architecture, with national repositories linked by a European Hub. There is also provision for a template national system for those countries who do not yet have one – simplifying the roll out process. I’ll post more information as I analyse the RFI more fully. This will be a flagship project for all vendors getting into the serialization space so expect tough competition to get on the five vendor shortlist. See you in Brussels later in the month for the information day. If you’re working out your serialization strategy (as a vendor or as a manufacturer) then get in touch with me directly at mark(dot)davison(at)bluespherehealth(dot)com or use the Contact Us function.
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Pharmaceutical Anti-Counterfeiting: Lessons from Avastin

Counterfeit medicines are not an entirely new thing in the American consciousness but when fake Avastin was reported this week it sent a larger than usual ripple through the news media.  I have been interviewed in the past 24 hours by Al Jazeera (see link or at right) and the Wall Street Journal. Why the fuss? Maybe it was because Avastin is a Swiss-designed, injectable cancer drug used only in hospitals.  This is a long way from dodgy Viagra bought over the internet or on a foreign trip, which is the image most people associate with fake drugs – if they even consider the issue at all.  Somehow, counterfeits have breached what should be a super-safe hospital supply chain and may have put patients at risk (although exactly how many patients received the medication is unclear).  Roche and Genentech were not directly at fault in this case but are there lessons that can be learned from their misfortune? How and why did this event happen and what can companies do to stop it happening to their products? The simple answer to the “how?” question is that plausible-looking fake Avastin packs, bearing familiar brand names and logos and containing authentic-looking vials, were good enough to fool professional medics.  It might be impossible for doctors and nurses to check the chemical composition of the active ingredients, but closer inspection would have revealed that the packs were apparently French in origin and bore the hallmark of parent company Roche, not the livery of the US-licensed manufacturer (and Roche subsidiary) Genentech.  The appliance of common sense should then have started alarm bells ringing, and indeed it may have been user vigilance that picked up this event in the first place.  FDA is now investigating. The “why?” question is more complex but the answer boils down to organisations trying to shave dollars off their drug bill by buying from grey market channels.  The French packs were supplied by a foreign distributor to at least 19 practices in the USA. Where exactly the distributor got them from will be established (I hope) during the investigation.  If hospitals and medical systems stick to the standard, regulated supply chain there is very little risk of receiving counterfeit products but it is precisely when people go “off-piste”, as appears to have occurred in this incident, that they put patients’ welfare at risk. If you’re a drug manufacturer or distributor, how do you stop a counterfeiting incident damaging your reputation and harming your customers? The first stage is to have a strategic approach and to act before you have to.  Don’t wait for the calls from FDA, CNN and concerned patients.  As they say in aviation, if you think safety is expensive try having an accident. I have written here several times about our DRASTIC framework for approaching anti-counterfeiting in a planned way.  The current move to serialization, epedigree and other traceability systems is soaking up a lot of budget and management time this year. There are legislative deadlines coming up in the USA, the European Union and elsewhere that will require manufacturers to code every single pack they make.  This will enable far greater supply chain transparency than we have today and will make it far harder for counterfeiters to insert industrial quantities of product into the legitmate supply chain.  But the dash for codes should not obscure the role played by old-fashioned authentication.  Visual inspection and the use of physical features – intrinsic or added, visible or covert – to reliably differentiate real from fake products is still a valuable tool in the arsenal.  An integrated anti-counterfeiting strategy needs both digital coding and physical authentication.  Neither is sufficient in isolation but together they are a strong deterrent against all but the most determined criminals. For those who would seek to delay mandatory compliance deadlines such as those in California (2015) or the EU (2016-17), ask yourselves whether it wouldn’t be a better strategy to get organised and get moving with your own initiatives so that the next Avastin-type incident doesnt happen on your patch. If you don’t know where to start, or you need help fine-tuning your strategy and tactics, we can help.  Blue Sphere Health are worldwide specialists in serialization, epedigree, authentication and related aspects of product security.  Contact us today for a confidential discussion or get in touch with me personally right now at mark(dot)davison(at)bluespherehealth(dot)com.      
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Coding Packs for France (CIP13): Is Your Equipment Also Suitable for Serialization?

The need for Data Matrix codes on all pharmaceutical packs in France, from 1st January 2011, catalysed a flurry of activity as manufacturers scrambled to install printers, vision systems and pack handling equipment to get themselves ready. The good news was that the code format (GS1 ECC200 Data Matrix) was the same as was (and is) being proposed for the future pack-level traceability schemes in the EU, USA and (eg) Brazil. Therefore, the supposed side benefit for many manufacturing companies was that the equipment needed for the CIP13-containing Data Matrix code was the same type of equipment needed for any eventual full serialization programmes that might crop up. Capex investment and implementation costs were a one-off and two birds could be hit by the same stone. N’est-ce pas? Well, yes. If you are one of the companies that chose wisely. If you cut some corners to save money during CIP13 preparations you may have some upgrading to do before you are ready for full unit-level serialization. The legal requirement for France is to incorporate a fixed CIP13 number (effectively an SKU number or pseudo-GTIN) plus batch number and expiration date, into an ECC200 datamatrix code. Therefore the code is batch-specific not pack-specific, and only changes when the batch number or expiry date changes. The unchanging code can thus be verified on the line after printing using either optical character verification (OCV) or optical character recognition (OCR). As a general rule, the OCV option is easier to implement and requires lower spec (and cheaper) kit because it is just looking for the presence, absence or quality of a pre-loaded visual pattern (in this case the invariant code for that batch). This doesn’t work for unit-level serialization, because by definition every code coming down the line is different. The OCR method is needed, which analyses and “reads” each code and compares it in real time to what was supposed to have been printed upstream. This takes more computing power, needs faster synchronisation and requires higher-end vision systems. The more experienced purveyors of line equipment to pharmaceutical manufacturers have seen this coming and advised their clients to purchase suitably nimble capability the first time around. But not everyone has been so clearsighted. One major equipment vendor I spoke to predicts that manufacturers which chose to save money when implementing CIP13 by going for competitors’ products with the minimal possible specifications may have issues when switching on their OCR capability to address the need for serialization. If you think this might be you, do some testing early before compliance deadlines loom. To avoid these and other strategic and tactical mis-steps, measure twice and cut once, as the old carpenter’s adage goes. Blue Sphere Health can help you to evaluate your short and long term needs for serialization and epedigree and put in place solutions that work today and also put you in a good position to deal with foreseeable challenges tomorrow. Contact us for a confidential discussion of your requirements for authentication, serialization, epedigree or any other aspect of pharmaceutical security. For a primer on all aspects of serialization and traceability in pharma, buy the new report I have written for www.securingpharma.com In the meantime, happy holidays and meilleurs voeux pour 2012. Photo by Francois Schnell from flickr
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Pharmaceutical Serialization: Moving from If to How

Our consultants spend many of their days discussing the intricacies of drug traceability with our customers. We add value by bringing an external perspective gained from long experience in the industry (typically 20 years plus) as well as recent intelligence gained from meetings, project implementations, and conferences. I’ve just distilled some of this knowledge into a new report “Pharmaceutical Serialization: Moving from If to How” available from www.securingpharma.com. Read on – there’s a way you can get it for free. Recently, the changes in EU legislation and the potential initiatives in the US have sharpened the focus on the areas of serialization, epedigree and track and trace. Making some assumptions about the most plausible dateline gives deadlines from 2015 to 2017 and beyond for full compliance, although (as with anything involving legislators) these dates may slip. Given this three to five year timeframe, our customers have typically responded in one of two ways: 1. 2015 is just around the corner. Get unit-level coding done across all impacted lines as efficiently as possible and use the time available to make sure we select the best strategy, choose the best vendors, and do sufficient testing and validation. Think about associated issues of aggregation and data connectivity well ahead of time. 2. 2015 is likely to slip outwards and anyway we have three years minimum. Delay as much capex and opex spending as possible, in these tough financial conditions, and get the job done just-in-time. Plan for spending in 2013 not 2012. Regular readers of this blog will know which side of the argument I’m going to favour. As my recent analysis of the tasks and dependencies involved showed, there isn’t really any spare time. Much of the most impactful and resource-consuming activity does not involve wrenches, vendors or production lines (although installation and validation of line equipment is undoubtedly challenging) but instead requires departmental collaboration and internal resources. For example, master data (such as stock-keeping unit [SKU] codes) needs to be identified, “cleaned” to remove confusion and duplication, harmonised to GS1 formats and made accessible to the serialization and coding systems that will need it. Many companies do not have this data in anything like a suitable form today. Some of the biggest challenges, even for top ten pharma companies, occur after the unit-level coding step has been achieved. Aggregation, in particular, can be a real headache. This process – the association of unit codes with a shipper box code, then of the shippers with a pallet code – is complex and needs time and effort to solve. It may have deep implications for your warehouse management system. The need for large data strings and codes may also require more pack space than you currently have available. Do you need to switch to a slightly bigger pack format? I will cover some of these hidden bombs of serialization in another post soon. For now, the one-line summary is: get started in 2012 if you haven’t done so already. Wherever you are in the process, contact us to arrange a call or meeting to discuss your needs – let’s get something in the diary for early 2012. I’ll go further and give you a no-lose offer. Buy my new report. It will give you the global context, bring you up to speed on key obligations and give you some guidance on how to get started or how to move forward if you’re struggling. If you buy a departmental or corporate licence for the report and then subsequently initiate a project with Blue Sphere Health before 1 March 2012, I will deduct the cost of the report from our invoice. The departmental license is currently on special introductory offer until the end of December, so act now to secure your double saving. Enjoy the coming holiday season and recharge your personal batteries for 2012. It’s going to be a busy year.
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Serialization and epedigree: 2012 – 2017 plan

The end of 2011 is almost upon us. The coming of the New Year marks three more years until the California epedigree deadline of 1 January 2015. This may be superseded by federal regulations but the ones currently under discussion have the same deadlines anyway. The CA / USA epedigree mandate is the first of several big requirements for traceability in pharmaceuticals. The implementation of serialization as part of the EU Falsified Medicines Directive is likely to come soon after, in late 2016 or early 2017. Collectively, these new laws will re-engineer the way the pharma supply chain works. There are other initiatives before then (Argentina, China, India to name but three) but as things stand today the big game-changers will be California (or its Federal equivalent) and the EU. Still, at least you have three years or more to get organised. Maybe, given the rough waters the economy is in right now, there is even an argument for executive management to save money by delaying some activities for another year, right? Wrong. As part of a consultancy project recently, we did an evaluation of the activities that need to go into an epedigree and serialization compliance program. We broke those down into discrete and measurable activities that individuals and departments would need to accomplish in order to be ready for the compliance deadlines. When you work backwards from 1/1/2015 and make some plausible assumptions about task durations and dependencies, you get a high-level Gantt chart for serialization and epedigree that starts in January. Not January 2013 or 2014, but this coming January. The highlights of the chart are here: Serialization and epedigree planner 2012-2017 The big ticket Capex spending on software and hardware can just about be left until 2013 if you have a degree of risk tolerance, but there are a lot of preparatory things you need to do before the guys with wrenches and servers get to work. These must start now if you haven’t already got going and may well impact Opex next year. The sort of activities that take a surprising amount of time are: Conversion to GS1 numbering Printing variable data on packs is often seen as the main problem in serialization. However, arguably an even bigger challenge is to sort out the fixed data. Information such as stock-keeping unit (SKU) codes and other internal reference numbers is often housed in disparate places. There may be multiple “synonyms” for the same item as systems have grown by merger and acquisition, or due to divergence of numbering practice between regional offices etc. As a pre-adaptation step for GS1-based traceability systems, all of these numbers must be harmonised and migrated to specific standard formats. SKU numbers, for example, need to move to Global Trade Item Numbers (GTINs) so that there is single numerical reference for each item type worldwide. Do not underestimate the amount of time and resource that this takes. I have heard several conference presentations recently from top twenty companies who took 12 to 24 months to get this right. Vendor selection and procurement There is a risk of a version of the Y2K issue in pharmaceutical serialization as the key deadlines approach. Vendor resources are finite and may become stretched. If you wait too long to select and order your equipment and software you may have to wait an uncomfortably long time. Strategy As military leaders from Sun Tzu to Montgomery have noted, time spent on reconnaissance is rarely wasted. Take the time to get the right strategy and get management backing for it. One serialization executive described his company’s juggling of manufacturing capacity whilst installing serialization capability as “like three-dimensional chess”. It is not something that can be left to individual plant managers. Conclusion This post is not an exhaustive analysis of serialization and epedigree but I wanted to highlight the need for urgent action in 2012. There is a lot to do but Blue Sphere Health can help you to get there. We provide consultancy at all stages of the process, from initial management workshops to training to implementation across sites. To discuss your needs in confidence, please contact us now to plan a call or meeting. Photo: alancleaver_2000 from flickr
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Safeguarding America’s Pharmaceuticals Against Counterfeiting and Diversion

September 22nd, 2011 saw the introduction of HR 3026 or the ‘Safeguarding America’s Pharmaceuticals Act of 2011’ into the US House of Representatives. Itself an update of an earlier bill, the document contains some interesting elements that could have big repercussions. Taking the Fifth… First of all, let me give the standard caution that most bills don’t make it out of the committee stage so this is a long way from being law. However, assuming for a moment that it represents current Democrat thinking, let’s examine what it would mean if passed. Pedigrees The bill is based on the ‘pedigree’ model, with (broadly) every transaction recorded for every pack as items travel through the supply chain from Authorised Distributors of Record (ADRs) or manufacturers right through to pharmacists. This is in contrast to the likely model in Europe, where end-to-end verification is favoured as a more workable option. In the latter, so-called ‘bookend’ systems, the pack is coded and checked at the manufacturing or packaging step and again at the pharmacy before dispensing but all intermediate code checks during distribution are optional. Big Pack, Little Pack, Cardboard Box Pedigree imposes a much higher burden on the supply chain, partly because the most practical coding technology is visible printed codes – usually in a two-dimensional matrix format. These codes require line-of-sight: the scanner must be able to ‘see’ the code optically with no intervening opaque packaging. This is an obvious problem when packs are aggregated into shipping case and pallets. It is simply not feasible for distributors to unpack, scan and repack large volumes of material, so a workaround known as ‘aggregation’ is used. In this process, the unit pack codes that go into a larger box are associated together in a database together with a secondary code that is applied onto the bigger container. The process is repeated as necessary up to pallet level. Mongrels Thus by scanning a single code on the pallet, an operator can (in theory) find out the codes on all of the unit packs contained within. This all works well. Until it doesn’t. The pharmaceutical distribution process is complex and for many reasons shipments are broken down, mixed with other products and reaggregated before being sent onwards. There are multiple opportunities for someone to fumble the ball and when they do the whole consignment could become unsaleable due to lack of a viable pedigree. Return-to-Sender Encouragingly, the returns process is also addressed in the Bill and included in the pedigree requirement. The ‘reverse logistics’ operation of returning expired or unwanted goods back up the supply chain has been vulnerable to fraud in the past. Code but no Enigma Standardized numerical identifiers will be needed for a coherent coding and tracking system and this is also addressed although FDA thinking on this has been provided already. The danger of a non-globally-aligned numbering format seems to have passed and any implemented system is likely to be a GS1-harmonised structure based on existing National Drug Codes. California, USA The timetable for applying codes to packs is pretty much that of the existing California pedigree deadlines, i.e. starting on 1 January 2015, and (sensibly) any Federal regulations would automatically supersede state provisions. So no shocks there on timing but a much bigger scale of challenge to comply nationally on the same timescale. This timeline also ties in broadly with the anticipated schedule for the implementation of traceability provisions in the EU Falsified Medicines Directive. SWOT Team The Bill also calls for a study into threats, technology choices and gaps in current government processes. This is to include ‘consultation with technology developers, drug manufacturers and other interested parties’. Time to make your thoughts heard. Conclusions This is just my initial reading of a Bill that may well not come to pass. There are no easy ways through this serialization / pedigree problem but we owe it to patients to try to seal the supply chain against fake drugs. Any traceability system will be complex, but I think going for a full pedigree model in one step is not the way to go. It is technically feasible, but it will be needlessly expensive and risky compared to the alternative model. Next steps If your company is struggling with these issues and you need some advice on strategy, technology choice or other aspects, then contact Blue Sphere Health. We help customers to solve these traceability challenges cost-effectively and in a way that adds value rather than just raising costs. For a fuller discussion of supply chain issues, authentication and other elements of the fight against counterfeit drugs, see my new book “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs” (Wiley, 2011) reviewed here.
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EU Falsified Medicines Directive: What’s Happening Next?

The ratification of the European Union’s Falsified Medicines Directive marked the beginning of the end, or at least the end of the beginning of a long process. This was the first time that such a large economic bloc had passed clear legislation aimed at securing the supply chain for pharmaceuticals. Cautious rejoicing all round. The next stage is that remaining details of the Directive will be converted to law by a “delegated acts” process. A fairly new legal procedure, this will be where the deal-making is done and the detail is finalised. There are lots of critical details to discuss, even before the lawyers get involved with drafting the wording itself. Who pays for what? Where does the data go? Who has access to it? What security features need to be used? etc, etc, etc. Two key tasks are being conducted in parallel. Firstly, an economic impact assessment is being conducted to look at what this will cost and who will bear the burden. This is likely to take some time. At the same time, a stakeholder group will examine technical issues under the oversight of the Directorate General for Health and Consumer Policy (commonly abbreviated to DG SANCO) the Brussels directorate responsible for the process. This stakeholder group, which includes trade bodies representing drug makers, distributors, repackagers, pharmacists etc, will try to thrash out a pragmatic, affordable solution which allows the implementation of traceability and security features at a reasonable cost. There are five main themes to be covered: Unique identity (serialisation): technology choice and implementation Governance of the system: deciding who sees what data and on what terms Modalities of verification: deciding how packs will be verified and what level(s) of authentication feature(s) will be required Whitelist and blacklist criteria: determining which prescription drugs are excluded from key requirements (deemed safe) and which non-prescription drugs are included (deemed risky)? Mechanism of notification: of whitelisting and blacklisting Prickly issues like ownership and use of information will need creative solutions. Drug traceability data is a boon for anti-counterfeiting but it contains very valuable commercial information and potentially could be linked to very sensitive patient data. One idea mooted is to use a not-for-profit vehicle to “own” the central repository or data exchange mechanism, with 15 or more national databases linking in. Public sector leadership has also been proposed. The timescale for the technical evaluation process is expected to be similar to the impact assessment, so the output for both is likely to be during 2014. There will be a three year implementation window once the Delegated Act is published. So the main activity in terms of capital expenditure and equipment installation by the pharmaceutical industry is likely to be geared towards being ready for roll-out from 2017-2018. Given the remaining uncertainties, and the other mandatory serialisation requirements in a similar or earlier timeframe (USA, Brazil, China etc) the best course of action for drug manufacturers is to be flexible in their approach. They need to ensure that their technical response (hardware, software and processes) stands the test of time and is able to respond to potential geographical variances. So take the time to work out a coherent strategy, but don’t wait too long or the queue for the most sought-after vendors might get a bit too long. Blue Sphere Health is helping several drug companies to formulate their thinking in this area. For more information on how we can help, please get in touch.
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Pharmaceutical Anti-Counterfeiting

Combating the Real Danger from Fake Drugs has become a must-have primer on anti-counterfeiting and is widely used by drug companies, regulators and others. The book covers the legal, strategic and political issues as well as the technical counter-measures such as process control, digital serialisation and physical security.


Pharmaceutical Anti-Counterfeiting book