Blue Sphere Health

Pharma’s new Y2K: will the toaster explode?

toasterBack in the late ’90s, everyone was checking their software for “Y2K” bugs caused by two-digit date abbreviations left over from the dawn of computing. When data storage was an issue and the millennium seemed a long way off, a two-digit year was a useful saving over the full version. Engineers misjudged how long this short-hand would persist. Fast forward several decades and our lives relied on things with date counters that were soon going to flip over from “99” to “00”. Everything from banking to spaceflight to household equipment might be at risk, if embedded systems reset to 1900 not 2000.  Even toasters were mentioned, although why they needed to know the date eluded me. On 1st January 2000, very few of the glitches happened. My fridge was cool about the whole thing. But who knows how painful and damaging Y2K would have been if corporations hadn’t prepared by mitigating the risks and making sure that mission-critical systems were ready?

Dots on the Box

In the next few years we have a Y2K-like period in the pharmaceutical supply chain, with closely-spaced legal deadlines in the US, EU and elsewhere for pack coding (serialization). This is more than just putting a new square of dots and some extra text on the box. It is a revolution in traceability and, we hope, security. It changes the supply chain paradigm from “batch” (thousands of identical packs in the same batch or lot) to “instance” (a single pack). The impending flood of new, variable data generated by this change will create huge challenges. Many of our customers and colleagues are spending millions installing printers, cameras and data systems that can cope with applying and checking unique DataMatrix codes up to five times per second on a moving production line.

When Fixed is Broken

Creating and managing variable data is only one of the challenges embedded in the EU Falsified Medicines Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA). Many pharma clients admit privately that their fixed or master data (product attributes, pricing codes, facility locations etc) is not as clean and tidy as it needs to be.  Their product codes may not yet be in the right “Global Trade Item Number” number standard – I’ve heard “GTIN” spoken like a four letter expletive. Such gaps, duplications and inconsistencies take time and resources to iron out. They don’t get the headlines like serialization does, but they don’t self-resolve, either.

Don’t Neglect the Processes

Companies may have gaps and deficiencies in their business processes, too. That thousand-fold jump in supply chain resolution I mentioned above causes ripples right through the organization and across the partner network. Standard Operating Procedures need to be revised or developed across many departments. Modelling the flow of data and doing a gap analysis is a valuable exercise. Even generating an accurate supply chain map is a good start – surprisingly, some companies don’t have one. Legal agreements with CMOs will need revision. This is all cross-silo stuff that pharma typically hasn’t excelled at. Make sure that the new systems and processes work without the implicit, in-my-head knowledge of any one person.

Telling the Authorities

The FMD and DSCSA also create reporting obligations for unexpected data. When potential falsification incidents occur on your watch, you have to tell them. These are not just “whenever you’re ready” requests. They are “immediately” or “within one business day” commands. Without sharpened processes and perhaps new Knowledge Capture software (see previous post), many drug companies could struggle to cope.

You Were Warned

The millennium was unmoveable. The deadlines for FMD (Feb 2019) and DSCSA (from Nov 2017) may shift, but if I were an executive at a pharmaceutical manufacturer, contract manufacturer or distributor I wouldn’t want to bet my company on it. See my earlier post for an email to send to your boss if you get it wrong. There is still (just) enough time but if you try to delay further or cut corners you might not be compliant in time and therefore unable to sell product. Your metaphorical toaster may not malfunction in the end, but you might want to make a lot of toast in advance, just in case.
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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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Why Imperfect Counterfeits Are Effective

Wasps are one of the hassles of the English summer and have an abiding fascination for picnics and the inside of windows. They also have something to teach us about brand protection, so bear with me as I take us on a short entomological journey. Not much eats wasps, and for good reason. Their yellow and black stripes are a visual warning of a nasty sting and an unpalatable taste. Predators quickly learn to avoid them and move on to easier prey. This fact has not been lost on harmless hoverflies, who belong to an entirely different insect group and are more closely related to houseflies. Many hoverflies look very much like wasps. The evolutionary strategy, called Batesian mimicry, gives them a survival advantage since birds and other predators largely avoid them. Hoverflies lack a sting and are thus defenceless if their bluff is called, so you would think they would evolve over time to be well nigh indistinguishable from wasps. However, it turns out that hoverflies don’t always need to make a perfect job of mimicking wasps to gain the benefit. Some are pretty good copies but some species are just vaguely yellow and/or a bit stripy. As elegantly demonstrated in an article in Nature last week (doi: 10.1038/nature10961) the similarity between hoverflies and wasps increases with body size (of the insects, not the observer). The authors show that this correlation is probably because smaller flies are less attractive to predators and so don’t get eaten as frequently as larger ones. They therefore have less selective pressure to be a perfect match to their stinging cousin. For small hoverflies, fooling most predators most of the time is apparently good enough, on average, and evolution doesn’t over-exert itself. On the flip side, birds like to eat big insects so if you’re large and juicy you’d better look pretty much identical to a wasp if you don’t have a sting to back up the visual threat. The article made me wonder if this relationship applies in pharmaceutical counterfeiting. Is there a correlation between size (of the benefit to the counterfeiter, in this case) and fidelity (the visual exactness of the counterfeit or its packaging)? If this is the case, counterfeits of expensive drugs should be more convincing than those of cheaper drugs, on average. This fits with intuition and anecdotal evidence but I’d be intrigued to see an academic study. More interestingly perhaps, can we use other elements of evolutionary theory to tackle counterfeiting? As I have pointed out before (Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs, Wiley, 2011) there are several parallels between biological evolution and the ongoing war between genuine and counterfeit manufacturers. If the hoverfly theory predicts that low priced fake goods don’t need to be good copies to gain an economic benefit, how can we change the game in favour of genuine products? How about raising predation levels? If my analogy is right, then the tactics are clear. Coordinated, collective swoops by all brand owners in a region, focused on the small flies (low priced products), should drive some counterfeiters extinct and force others to evolve more expensive mimickry to stay in the game. Life gets harder and the cost of doing business goes up. In the long run, this tactic of targeting all low priced brands should be more effective in protecting public health and in reducing the overall burden of counterfeiting than efforts by individual brand owners to protect their expensive brands with their own internal resources. This logic means that building local enforcement capacity is just as important as putting ever-more sophisticated taggants, holograms or closure seals on our packs. The arms race between criminals and genuine manufacturers is not going to be over any time soon, but we need to be systematic in how we fight the war. Its not rocket science, but it is science. If you want to discuss your brand protection needs, contact me at mark(dot)davison(at)bluespherehealth(dot)com or leave a comment below. Photo: Mark Robinson from flickr
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US drug serialization and traceability: not such a distant dream

The emergence of the Pharmaceutical Distribution Security Alliance (PDSA) as a growing force in the long running epedigree / track and trace / serialization saga was completed during a US Congressional hearing recently.  The whole hearing (which covered a variety of areas including Accelerated Approval, Medical Gas, Antibiotic Development and Downstream Pharmaceutical Supply Chain) can be heard again online but the highlights for our purposes are the opening presentation from Janet Woodcock of the Food and Drug Administration (FDA) and then “Panel III” on supply chain security from 2h 34m. The US industry consensus (manufacturers, distributors, pharmacists) is clearly aligning behind the PDSA suggestion (referred to as the “RxTEC proposal”) which calls for lot-level pedigree with unit-level pack coding.  This will entail mandatory peer-to-peer sharing of lot or batch information during the normal course of commerce, providing a lot-level transaction trail or pedigree as product moves through the supply chain.  Additionally, each individual pack will have a unique serial number which can be used for verification or other purposes but will not be part of the mandatory data set that must be passed during each transaction.  This avoids the need for many of the onerous, time-consuming and therefore expensive new processes that a full epedigree system would require.  For a fuller discussion of the various modes of traceability and their implications, see Dirk Rodgers’ excellent RxTrace blog. This hybrid model, which is either “pedigree-lite” or “serialization-plus” depending on your point of view,  has some key benefits. The first major advantage over previous attempts to implement traceability in pharma is that it is a pragmatic approach.  It is still a challenge but not an insurmountable one.  After years of meetings in Sacramento trying to persuade the California Board of Pharmacy to agree another stay of implementation of their pedigree requirement, this is a much more productive approach and probably the best shot at developing a federal solution that works. The second key step forward is that (unlike previous approaches) the RxTEC model seems to have the broad support of many of the stakeholders who will have to make it work (manufacturers, distributors and pharmacists). This gives it a fighting chance of actually happening. Thirdly, it is expandable to full pedigree as and when the capability or need is there.  Nothing in the PDSA proposition precludes a full epedigree environment in the future.  But if epedigree is like the Apollo programme, RxTEC is just taking the sensible step of testing components in Earth orbit first. Finally, global compatibility is made much easier by this new paradigm.  Blue Sphere Health does a lot of consultancy work with manufacturers on traceability in Europe, USA, India and elsewhere.  Our customers are wrestling with the problem of how to reconcile the needs of potential epedigree in the USA (because if you put systems in place for California, effectively you have to do it for your whole US supply chain) with the different system of end-to-end verification that is likely to be the model in Europe.  They also have to try to hit curve balls thrown by projects like the potential eTACT system being developed by the European Directorate on Quality of Medicines and the traceability systems in Brazil, Argentina, China, India etc. See www.securingpharma.com for more on these stories. If the necessary legal language can be agreed and incorporated into the Prescription Drug User Fee Act  (PDUFA)  reauthorization process this year, which is the chosen tactic for rapid approval, then this lot-level system might happen soon (ie 2015).  It would replace the California law which has specific federal pre-emption clauses for this very purpose.  Anything which turns a state-level impasse into a pragmatic and achievable federal system deserves our backing.  Patient safety demands that we get this done. We specialize in advising clients on these issues.  Contact us for more details or email me personally at mark(dot)davison(at)bluespherehealth(dot)com.
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Supply Chain Processes: Are Any Of Yours Generally Recognized As Unsafe?

The US Food and Drug Administration has a tough job. The burden of ensuring the safety of consumers and patients requires them to review large dossiers of data for new molecules prior to granting approval for marketing.   They must assess novel pharmacology and gauge the likelihood of hitherto unseen drug interactions.  One way that FDA cuts the workload is by allowing manufacturers to use some well-known ingredients without seeking reapproval.  The list of ingredients which are “GRAS” or Generally Recognized As Safe allows collective knowledge and data to be taken as read, saving time and money for all concerned. It occurred to me last week during the counterfeit Avastin story that we should develop an analogous but reverse logic for supply chain processes.  My proposed list of “GRAU” or “Generally Recognized As Unsafe” practices would be a guide to collective wisdom on how to avoid an insecure supply chain. I’m talking about things which aren’t technically illegal but are either pretty unwise or straight reckless. Happily, the acronym is also the German word for grey (or “gray” for US readers) which allows me to segue to point number one on my list: grey market procurement: Many cases of harm being caused by diverted and counterfeit medications boil down to people seeking to save a buck by buying outside the regulated sales channels.  As Adam Fein and others have noted, the Avastin incident would not have occurred if the drugs had been bought from standard US distributors.  Anyone who still thinks that buying drugs by blindly focusing on price alone is a good idea should read “Dangerous Doses” by Katherine Eban. In fact, just read it anyway. One of our other surprisingly common findings is: returns processing without safeguards: If someone can return your product and receive a refund with no questions asked then you are opening the door to fraud and counterfeiting.  It may seem obvious, but the authenticity of all returns should be checked before payment is made. Some companies outsource returns processing – are your service providers doing the necessary due diligence? These are just two recurring themes that shouldn’t be allowed to recur any longer.  There are dozens of other unsafe processes that we come across in our work at Blue Sphere Health.  Some of them are covered in my book “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs”.  Others are confidential to customers (and have now been fixed). Anti-counterfeiting requires attention to processes – security technology does not compensate for poor business practices.  If you need an independent audit of your product security processes then contact me confidentially at mark(dot)davison(at)bluespherehealth(dot)com or use the Contact form.  Feel free to add your own public domain GRAU ideas in a comment below (or send to FDA). Photo: www.failblog.org (the site is a good way to fill a coffee break if you like the absurd side of life)
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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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Pharmaceutical serialization and epedigree: simple tips for 2012

Blue Sphere’s year is already getting busy, and the nature of the work we are being asked to do tells me that serialization is now starting to become unignorable. Working backwards from a California / US implementation deadline of January 2015, any globally-operating corporation that does not have coding projects under way for its US supply lines needs to start now. As I noted in an earlier post, the typical 18-24 month lead time for serialization and epedigree projects means that latecomers have now run out of slack . The capex requests for equipment to be installed, tested and validated during 2013-2014 will need to be submitted to executive management by the end of this year. To be accurate and meaningful, these proposals need to be preceded by scoping studies, business case preparation, gap analysis, implementation planning and other activities during 2012. All of these soak up time and resources and require specialist skills that smaller companies don’t always have. Depending on where you are on the preparedness spectrum, I recommend the following actions this year: Not started yet (or only local, tactical solutions):
  • Get a project sponsor quickly – at least at Vice-President level and preferably higher. You will need “top cover” to drive through any necessary changes.
  • Appoint a project champion with sufficient time and influence to get things done. I suggest at least 0.5 full time equivalent (FTE) and if you’re starting from zero you may need 1-2 FTEs to get the job done this year. This can be internal or external resource.
  • Move quickly to establish an inter-disciplinary project team. Involve supply chain, manufacturing, quality, marketing, legal as a minimum. Don’t forget to talk to your third party manufacturers, marketing partners, key distributors etc.
  • Organise a management workshop to explain to senior management the key compliance obligations and business benefits.
  • Present an initial options analysis to stimulate discussion and guide the next stages.
  • Develop a draft strategy that fits with corporate goals and external obligations
  • Decide whether you have sufficient resources and expertise in-house or whether you need interim management or external consultancy support to do the activities listed below.
  • Conduct (or commission) a scoping study: go round the manufacturing sites and figure out what needs to be done and by whom.
  • Check whether any commercial data processes or contracts need to be changed. Plan ahead or these administrative issues will return to bite you just when you thought you’d solved the technical puzzle.
  • Contact equipment and IT vendors for guidance on costs and timing of your preferred option(s). The quicker you get in the queue the better.
  • Make sure you develop an appropriate Request-For-Proposal that gives vendors sufficient information to be able to help you.
  • Based on your analysis, form an implementation plan.
  • Write a business case.
  • Present the case to the board (or whatever your approval process involves).
Some way down the track but not fully serialized:
  • Make sure you have the activities listed above covered.
  • Perform (or commission) a gap analysis to look for any remaining weaknesses, disconnects, process misalignments etc.
  • Audit existing equipment to check that it is sufficiently future-proof.  For example if you installed printers and vision systems for CIP13 batch-level coding for France, make sure they are also capable of the (much harder) task of serializing every pack.
  • Keep abreast of new legislative developments.
  • Benchmark your progress against your peers. Get external perspectives if necessary.
  • Look for business intelligence outputs from pack coding that can help you improve your business
Fully ready for serialization and epedigree worldwide: Congratulations, you are ahead of the game. Spend the next couple of years feeling smug but don’t get complacent.  Regulations can and do change and timelines shift. One thing you might also want to check is that your staff are on the same wavelength as you are.  Often there is a training gap – management knows what is required and why, but colleagues further down the tree are less aware of the project and why it is important.  This can lead to misunderstanding and delay.  Avoid this situation by running workshops and training courses for key people through the organisation who can act as local champions to make sure that the project stays on track. These are not exhaustive lists and some of the tasks will overlap or occur in parallel, but I hope they provide a useful starting point.  The activities highlighted in bold can be outsourced partly or wholly to Blue Sphere if you have resource constraints or need to get going rapidly. Don’t leave serialization to chance – contact me for a confidential discussion today. Photo: Daniel Moyle from flickr  
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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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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