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Posts Tagged ‘anti-counterfeiting’

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 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

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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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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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Safeguarding America’s Pharmaceuticals Against Counterfeiting and Diversion

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

Globally-coordinated action involving 81 countries has led to dozens of arrests and the removal of websites believed to be selling counterfeit drugs. Operation Pangea 4 was coordinated by Interpol and involved regulatory and law enforcement authorities from around the world including the Metropolitan Police and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Like previous operations, close coordination was the key to success. The internet is a critical battleground in the war on fake medicines and the scale of cooperation involved in Pangea 4 and its precedents is encouraging. I know from personal contacts how much individual toil and commitment lies behind these initiatives, and we should congratulate all concerned. The same level of cooperation is starting to happen in the the authentication and traceability of genuine drugs. Serialization and epedigree initiatives, such as the measures outlined in the EU Falsified Medicines Directive this year, will gradually improve supply chain security. A layered authentication approach to security features on packaging and (where appropriate) the addition of physical-chemical identifiers in the formulation itself will make it harder for counterfeiters to keep up. I have discussed strategic frameworks here before and my new book has some discussion of the wider issues and available counter-measures. You can buy it direct via the button on the right of this page. There are no magic bullets against counterfeit drugs and we will probably have to accept that this crime can never be fully stamped out, but let’s take a moment to focus on what we CAN do. Operation Pangea 4, and the other coordinated initiatives now starting to happen, are a major step in the right direction. Photo: Interpol
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Africa: Dumping Ground for Dangerous Fake Drugs

The post below was written a year ago, but since the publication of my new book (“Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs” Wiley, 2011) I wanted to revisit the subject. Some interesting initiatives are coming up on internet pharmacies and traceability (serialization) of drugs in Europe and the USA, but Africa and other developing regions are where the damage from fake drugs is at its worst. Africa is awash with counterfeits of all types, to a level not easily appreciated unless you see it with your own eyes. In one African capital a government official showed me boxes and boxes of different confiscated products such as shoes, pens, razors, batteries, shampoo and medicines. These items are usually shoddy at best – the ‘leather’ shoes are made of cardboard and dissolve in the rain, the pens only last two days. Sometimes the products are injurious – fake razor blades often have blunt or jagged edges. Counterfeits can also be lethal: fake artemisinin therapy may be a death sentence for a three-year-old whose malaria remains untreated. The industrial rise of many developing nations has led to a hierarchy of product safety: Developed > Fast Developing > Africa. In European and US markets we are concerned about fake products when we find them, but we have sophisticated monitoring and law enforcement systems that can spot even low levels of fake or sub-standard product. The true problem lies largely unreported in Africa which is at the bottom of the heap, deluged by low cost, poor quality goods and counterfeits. The same low-wage countries used by western brands to reduce production costs are now dumping large quantities of manufactured garbage into Africa. This does not just affect international brands. An African entrepreneur told me how he was put out of business when his locally-made toiletry products were copied by Asian counterfeiters. Even cheap items can be counterfeited profitably if the volume is high and the quality of the fake is low. Africa is now living with an epidemic of counterfeits to add to its other problems. This erodes daily life with petty inconveniences and wasted money but in the case of fake drugs the effect is much more severe. Some of the bigger, richer nations such as Nigeria can fight back on their own with some success. Regional coordination is also improving but the seizure of huge quantitities of fake medicines in coordinated operations such as Interpol’s recent Mamba III is probably only the tip of the iceberg. It doesn’t matter which statistics you believe about the global level of fake drugs. Personally I don’t believe any one number because they are all built on the sand of poor data rather than on solid statistical foundations. The average prevalence is not the point. One percent, ten percent, fifty percent, whatever. All just irrelevant numbers if your child is dead from a treatable disease because the drugs you bought in good faith turned out to be worthless fakes. The long-term success of health initiatives such as the Medicines for Malaria Venture, aimed at one of the major causes of death in Africa, will depend not just on scientific innovation and ensuring wider access to medicines but on protecting Africans from fake medicines. Some of the things Africa needs to combat counterfeit drugs are low profile, unglamorous and probably hard to excite donors about: customs support, anti-counterfeiting technology, better retail systems, pharmacist training, consumer education. Some of it is happening, but not enough and not quickly enough. African governments do not have the finances or the resources to cope on their own. Many Africans will remain trapped in poor health unless we in developed nations attach as much importance to securing the African healthcare system as we do to providing innovative new drugs. Photo by John Steven Fernandez from flickr Creative Commons
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Book Review on RxTrace.com

I am delighted that Dirk Rodgers of influential pharmaceutical industry blog www.RxTrace.com has written a full review of my new book “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs”. I recommend you read the review and then look around Dirk’s blog for inspiration. Several of his in-depth essays were very useful in preparing the book. The sharp-eyed amongst you will notice a “buy now” button on this page if you want to get hold of a copy. The link takes you to a secure Amazon site. I am keen to get more reviews, feedback and suggestions for additional content in the next edition. Please leave a comment below or get in touch via the Contact Us page.
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Serialization, Data Flows and Gap Analysis

The diagram below is taken from one of our “Gap Analysis” projects. Key question: how to extract maximum benefit from investments in serialization and product tracking? Acronyms: LIMS – Laboratory Information Management System WMS – Warehouse Management System ERP – Enterprise Resource Planning EBR – Electronic Batch Records MES – Manufacturing Execution System The diagram looks complicated but is designed to illustrate the potential linkages between six of the different existing software pieces that a pharmaceutical company is likely to have. A similar diagram could be drawn for other industries dealing with medical or ingestible products. Between them, these data handling solutions could provide a large amount of information that is central to the control and prevention of counterfeiting and diversion. Since these software suites address current requirements, most of the investment has been made – although not usually by the same department – and these items are therefore a sunk cost. What is surprising to us is that often many of the arrows don’t exist in the real world. Systems are run as standalone components by departments that don’t always communicate efficiently. Where links exist they may be manual processes or local workarounds using XML files or spreadsheets. For the largely analogue pharmaceutical distribution world of today this may be sufficient. But as requirements for mass serialization gain pace (Europe, USA, Brazil, India, Argentina etc) managing the many billions of transaction points will impose new demands and create new opportunities. An Excel file won’t cut it in a few years time. By linking these six key components together more effectively, often with specialist middleware components, best-in-class drug companies are leveraging their existing software investments to develop real-time visibility of their products right through the life cycle from demand planning to returns management. To discuss your serialization needs and how to link traceability with other corporate data streams, contact me. We can conduct a gap analysis consultancy project over a few weeks that could save you millions of dollars over the next five years. As a bonus, every new customer this year will get a complimentary copy of my new book “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs” (John Wiley & Sons, New York, August 2011, 426pp)
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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