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

Pharmaceutical serialization (and/or epedigree) has been on its way for a long time. The uncertainty has been in the timing and the exact compliance requirements. Manufacturers didn’t know where or when serialization would turn up first, but they assumed that it was going to be scary. Sometimes the uncertainty and hyperbole that surrounded the subject reminded me of the chorus of the hit song by UK band The Automatic:”What’s that coming over the hill? Is it a monster?”

Now, at last, the apparition coming towards us is resolving into something we can see and start to deal with. The technical details of how drug traceability could work have been thought through. The European Federation of Pharmaceutical Industry Associations (EFPIA) has piloted its ideas in Sweden with apparent success – albeit in a limited geographical frame. They are now in the first stages of procuring the services and IT infrastructure to roll out their proposed European Medicines Verification System (EMVS) across the European Union. The German securPharm consortium is carrying out another pilot project with multiple stakeholders. The European Directorate for the Quality of Medicines (EDQM) has scoped out its eTACT project and intends to pursue it further. For a discussion of these three projects in more detail, download Blue Sphere Health’s free new white paper from www.securingpharma.com

The problem of how to code and trace drugs reliably and securely is a tough one, but progress has been made. The format wars of the last decade are now behind us at least. We know that datamatrix codes, not RFID, will be the predominant data carrier. The consensus (with some outliers, e.g. China) is that the international code format will use the GS1 standard rather than proprietary or local systems. Diverse groups have put aside their differences to propose collective solutions. In Europe, the stakeholder-led group includes EFPIA, the wholesalers organisation GIRP, repackagers EAEPC and pharmacists group PGEU. The US has seen similar activity with the Pharmaceutical Distribution Security Alliance putting forward a united and constructive front to US legislators.

The Technical Uncertainty Monster has been, if not killed, then at least stunned into temporary submission. But this is no time to be complacent. Now we have to watch out for his angry brother, the Cost Monster. The estimated running costs of the EMVS system, as released by EFPIA recently, are 1.3 – 2.2 Euro cents per pack. Since generics are typically five-fold cheaper than the branded equivalents, if applied equally the burden would fall disproportionately on cheaper medicines. A compromise will probably need to be worked out that takes pack price into consideration when setting the levy on manufacturers.

Grossed up for pack volumes in the EU, this cost range implies an annual running cost of 130 – 220 million Euros. The implementation costs in the first couple of years are likely to be a multiple of this figure. Let’s break these costs down and look at some of the more vulnerable areas where the Cost Monster might strike:

System design:
The suppression of various industry stakeholders’ vested interests in the name of a bigger cause has been impressive so far. To keep things as streamlined as possible all sides should continue to build trust and share infrastructure whenever possible. There is an argument for keeping pharmacy transaction data for pharmacists’ eyes only and away from manufacturers and to be fair the drug makers are not seeking access to point of sale information. However, physically separated dual database systems, such as securPharm seems to advocate are not the answer and would cause unnecessary complexity if rolled out across Europe. Database providers can design access rules that allow clear and secure segregation of data without the I/O movement and synchronising of information that multi-instance designs might require.

Complexity:
The EU has 27 member states. The more we can do to minimise the diversity of national systems the cheaper the overall cost will be. The EFPIA model will provide a national system blueprint that will be available as a pre-configured starting point to those states that don’t want to develop their own infrastructure. The same approach needs to be taken for pharmacy implementation and training elements of the roll-out. Re-using and adapting existing materials and processes will be critical to keeping costs under control.

Exceptionism:
Some countries (Belgium, Greece, Italy, possibly France although this is controversial) are granted a multi-year opt-out under the Falsified Medicines Directive, meaning they can continue with national traceability systems. In the interests of the greater good and of cost minimisation for manufacturers, it would be helpful if these states worked to harmonise with the EU framework as swiftly as feasible rather than delaying.

System implementation:
The IT consultancy and services element of rolling out any pan-European or federal US system will be huge. Even small process improvements and simplifications will add up to big savings over time. For this reason, the initial implementation should be as simple as possible – involving only those stakeholders and processes that are needed to get the traceability system started. Trying to implement epedigree will be hugely more expensive than starting with serialization. The lot-level approaches as advocated by PDSA are an even simpler first step.

Pharmacy integration:
The pharmacist is the key control point for drug traceability systems, so the rapid and efficient integration of pharmacies into any wide scale approach is critical. In focusing on the big-ticket IT components like databases, routing systems etc, we should not underestimate the complexity of getting tens of thousands of drugstores on board. Just ask Aegate who have spent years adding pharmacies to their systems in Belgium, Greece and Italy and still have nowhere near full penetration. Pharmacy point-of-sale software is a highly fragmented market making the IT integration task harder. Many stores use barcode scanners which are not compatible with datamatrix codes and will need to be replaced. Some rural pharmacies don’t have the reliable broadband internet connection needed for real-time authentication. Collectively these issues represent a vulnerable soft underbelly for the Cost Monster.

Support costs:
Things will not go right all the time, even when teething troubles have been solved. Providing transaction support in the pharmacist’s native tongue (the EU has 23 official languages) will require creative approaches. These issues have been solved in other industries (e.g. financial services) so pharma should look outside itself and not fall into its habitual trap of reinventing the wheel.

Conclusion
Most of the patient safety aims of pharmaceutical serialization will be solved with a relatively simple, uniformly applied and globally interoperable traceability system in each major region. This will be secure, with multiple separate access rights. Pharmacies will be integrated efficiently and quickly, recognising the network effect that comes with rapid and widespread participation. Design, installation, operation and support costs will be reasonable, using best practice from other industries to avoid unnecessary cost burdens on patients and taxpayers.

Alternatively, we can hide behind the sofa while the Cost Monster runs amok.

Contact me at mark(dot)davison(at)bluespherehealth(dot)com to discuss these issues in more detail and in confidence.

Photo: Silus from flickr

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.

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

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.

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)

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.

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

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

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.