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Webinar: How to Find, Control & Report Counterfeiting

We recently ran a webinar with Integritie to discuss how our integrated software and services can support your anti-counterfeiting activities. You can view the recording below. If you are building a compliance environment for the Drug Supply Chain Security Act (DSCSA) or the EU Falsified Medicines Directive, remember that serialization isn’t the whole story. Contact us for more information.

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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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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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US Office Opens

To service our growing list of US customers we have established a wholly owned subsidiary, Blue Sphere Health Inc. We now have a representative office in Norristown, Pennsylvania (just outside Philadelphia). Use the Contact Form to get in touch with us and see how we can help you with your product integrity, serialization and brand protection needs in the United States. We can help with Drug Quality and Security Act (DQSA) compliance issues as well as wider areas of strategy, tactics, implementation and vendor management. If you have operations in Europe we can also advise on Falsified Medicines Directive compliance.  Further afield, we have extensive experience in developing country markets in Latin America, Asia and Africa.
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Bluesphere Joins GS1 Healthcare

From January, Bluesphere has become a global member of GS1 Healthcare. This is the key forum for debating and solving coding and data management issues related to serialisation around the world. Joining this important group reflects our commitment to the development and use of harmonised standards for product traceability and we will be contributing our expertise to the various work groups.  We will also gain an improved visibility of the various regulatory and legal initiatives in this space, keeping us at the cutting edge of knowledge and helping us to keep our customers informed and prepared.

This is the first of several planned strategic developments this year to support the continued growth of Bluesphere as a trusted partner for traceability, brand protection, mobile health and patient engagement. Get in touch via the Contact Us form if you would like to know more.

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New year, new website

Welcome to the new look We have redesigned the site to make it easier to navigate to what you need. Whether you want to look at our results and case studies, check out our services or just read our blog, the new site should let you get there easily. Watch out for new features and enhancements over the next few months as we expand the site to keep pace with our own rapid corporate growth.  If you have any features that you’d like to see then please get in touch via the Contact Us page.
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Pharmaceutical anti-counterfeiting

securing the drug supply is a mission-critical activity

This corporate site continues the personal blog started by Mark Davison at The foundation of Blue Sphere Health was based on the observation that the world is not an equal place when it comes to healthcare security. Not exactly a Sherlock Holmes insight, admittedly. Anyone who has travelled to the developing world will have seen “prescription drugs” for sale to all comers with no questions asked. There is an urgent need to do something about it, before the scourge of fake drugs in the poor world becomes a global pandemic. Fear is a powerful force: if people don’t trust their medicine then they stop taking it, and their health suffers. People in rich economies who have never been in contact with fake drugs will have their wellbeing affected in this way if a cluster of counterfeits breaks out and uncertainty takes hold.

At Blue Sphere, we take a wide view of the problem before zeroing in on the potential remedies. We don’t claim to be a “solution provider” – if there was a quick fix then it would have been applied by now. We are not a technology vendor, although we can advise on technology choice. What we do offer is global pharmaceutical security experience, deep strategic insight into the drug industry and its commercial drivers, and a determination to do something positive about counterfeit health products.

We can work with you on serialization initiatives and supply chain security, with our extensive knowledge of the various legislative and regulatory initiatives around the world. The compliance map is getting more complex in pharmaceutical logistics and we can help you to orient yourself to the key points.

We also understand the critical importance of authentication in today’s supply network. We cannot rely on codes to protect our products – we need other ways to validate genuine items in the event of fraud, duplication or error in the coding and reading processes. The huge variety of authentication technologies available can be confusing but we have the knowledge and experience to sort the merely decorative from the truly effective.

If you would like to discuss your pharmaceutical security needs, in complete confidence, please contact us.

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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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Pharmaceutical Serialization: Killing the Cost Monster

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

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.

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.

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.

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

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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