Blue Sphere Health

Posts Tagged ‘packaging’

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: (the site is a good way to fill a coffee break if you like the absurd side of life)
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Book Review on

I am delighted that Dirk Rodgers of influential pharmaceutical industry blog 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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Anti-Counterfeiting: Six Summer Actions

Today is Independence Day in the United States. It is also the first Monday in July and the start of the summer vacation season. Getting anything done that involves teamwork seems to get inordinately difficult. I used to get frustrated by this period of the year – the benefit of two weeks holiday offset by reduced productivity for two months – but now I use the time to address the fundamentals of my company. When we are busy ploughing the furrow in the daily activity of our businesses or jobs it is easy to lose sight of the strategic factors that underpin them but the quieter summer months are a good time to focus on the long-term tasks that will really improve your performance for the rest of the year. If July and August are a less busy time for you, here are a few ideas for things to work on in the gaps. They will really improve your brand protection and anti-counterfeiting activities for the rest of the year. 1. Check your strategy: Do you have an agreed, signed-off brand protection strategy? Have you reviewed it lately? Unless you answered yes to both, then now is the time to write a draft or check and revise the existing document ready for discussion and approval when the boss is back from Hawaii. 2. Measure your risks: Have you looked hard at the prevalence of fake or diverted products recently? Don’t assume that because you didn’t have a problem last year then you’re safe this year. If you haven’t done a market survey for a while then now is the time to design one. 3. Build your internal network: Email or (better) call the managers of the local affiliates in all the countries where you operate (some of them will be at their desks) and say hello. Build your international network ahead of time and make it work for you – get views and suggestions and generate dialogue. Local eyes and ears are a much more effective (and cheaper) surveillance tool than your occasional long-haul trips from HQ. Next time something suspicious happens, you are more likely to get a timely alert if the manager knows you by name. 4. Reach out externally: The same principle applies to external contacts. In a busy customs office, vigilance is thinly spread. If they know your voice, have your number, and you gave them a training manual on how to recognise fakes of your product, then they are much more likely to help you. Make the contacts before you need them. 5. Train yourself and your staff: Summer is a good time for training small groups of people. Although budgets for general “soft skills” training are under pressure, there is still money available in most organisations for specialist training with defined outcomes. Brand protection courses provide direct and immediate benefits for a very modest outlay. We provide bespoke courses for corporate clients covering all aspects of anti-counterfeiting and brand protection. Make time to “sharpen the saw” as Stephen Covey’s seventh habit says. 6. Predict the future: Some events are beyond our control. They just spring out from nowhere and we have to deal with them as they occur. Most things are more predictable and they can be planned for in advance even if we have to adjust along the way. What legal initiatives, regulatory changes or quality trends will affect your business in the next five years? What preparations and benchmarking initiatives could you be putting in place today? Are there any useful reports you could buy that will give you a head start? Ironically, at Blue Sphere Health it looks like we’ll be having a busy summer this year, with the launch of my book on Friday, some great new training material we’re finalising, and ongoing consultancy projects. But if you hit a quiet patch and you’re getting frustrated by “out-of-office” email auto-replies and “call me back in four weeks” voicemail messages, try doing the six things above. I guarantee you’ll hit September in better shape to protect your brands from counterfeiting. Photo: StuSeeger from flickr
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Introductory Book Offer from

My new book, “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs” is published by Wiley in the next couple of weeks, priced £60 (RRP). You can buy it from this site via the button on the left, which will take you to the secure Amazon page. The book is a detailed primer on all areas of anti-counterfeiting in pharmaceuticals and allied industries. Although I have made it as complete as I could, it was finished and sent to the publishers before the EU passed the Falsified Medicines Directive in February. Therefore I recently wrote an executive report with leading industry news portal on the state of play in serialization and the global trends in pharmaceutical traceability. “Pharmaceutical Serialization: Opportunity or Perfect Storm?” contains analysis, executive interviews and data and it shows clearly what companies need to do to anticipate traceability requirements without incurring unnecessarily steep costs. This high-value report is available now from for only £299. For a limited time only (until Friday 8th July) Blue Sphere Health and are offering a free copy of “Pharmaceutical Anti-Counterfeiting” with every order of “Pharmaceutical Serialization: Opportunity or Perfect Storm?”. That’s a £60 textbook, hot off the press, for free. Don’t wait too long or you’ll miss it. Go to to order your report and free book today.
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Average White Brand: Primitive Packaging Holds Pharma Back

poor anti-counterfeiting featuresHaving written a couple of posts recently on the value of simplicity, this one redresses the balance with a thought on prescription drug packaging.  Looking around any pharmacy in most countries, you will see shelf after shelf of white boxes adorned with nothing more than a few lines of small black text, the product name in slightly bigger text, and a discreet logo. Artistic minimalism is often driven by regulatory restrictions, but it has two consequences. Firstly,  the fact that everything looks the same increases the likelihood of medication errors.  This risk starts at the pharmacy. Even highly trained pharmacists can mistake an “80mg” pack for a “40mg” one if they are in a hurry and there are no other design or graphical cues to differentiate two dosages of the same thing.  Good process flow and adequate checks can prevent many of these errors in the controlled pharmacy environment.  But what about when the patient gets home?  If they have four or five white boxes in their bathroom cabinet they can easily mix them up and mis-dose. Secondly, the simple, easily-reproduced white box (or brown bottle) is a gift to counterfeiters.  Why make their life easier than it needs to be by giving them a childishly simple design to emulate?  I’m not suggesting that all medicines should be packaged in rainbow-coloured boxes in complex polyhedral designs, but surely there is room for some 21st century graphical sophistication? More complex designs would allow pharmacists and patients to tell products apart.  How many people have drunk Sprite believing it to be Coke? Not many, because the brands are highly distinctive even though from the same manufacturer. Graphical sophistication would also allow anti-counterfeiting and authentication features to be hidden much more seamlessly into the background, rather than applied as a separate rectangle that screams “BRAND PROTECTION FEATURE, PLEASE COPY”. I know there are loads of reasons why pharmaceutical packaging is the way it is, but I don’t buy any of the arguments for why it has to stay that way.  Patients: time to demand change. Regulators: time to wake up. Photo: yowlong 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