GSK were alerted to counterfeit products by customers.  On inspection of the packaging there was a number of inconsistencies between the authentic and fake packs the difference in the product however are more serious.

This is yet another counterfeit issue  raised, surely this case and others demonstrate the size of the  opportunities for the packaging industry to deliver smart and cost effective solutions.

Annie Dallison

FDA is warning consumers about counterfeit Alli reportedly sold over the Internet. Testing by manufacturer GlaxoSmithKline has revealed that the fake products contain the controlled substance sibutramine, not contain orlistat, the active ingredient in its product. FDA warns that this fake version of Alli 60 mg capsules (120 count refill kit) could be harmful if used improperly.

Via PPM News 20th January 2010. You can read the full article by clicking: http://bit.ly/5y3Pxy

Interesting move from Nestle, who will be next to follow?  There is definitely a market out there, and as the average age of the population rises and people live longer it’s an area of the market that is likely to grow in size. I hope they’ve got the packaging right though – easy to open closure and legible text will be a must! (Jane)

Nestlé has launched a 200mL nutrient drink in Switzerland targeting the malnourished elderly – a segment of the population it says is deficient in key nutrients such as vitamin D, calcium and protein.

via Nestlé target elderly with high-dose drink.

The development of both the BSI & CEN standards for Braille on Pharmaceutical Packaging have taken years of dedication from the Working Groups with clear commendation coming from the RNIB for the support they have received from the Packaging Industry.

The following article provides an interesting insight into the issues encountered from the RNIB perspective. It clearly demonstrates the amount of work and angst that has taken place over the past few years to make this happen and reach this breakthrough milestone. Three years ago many people thought that this initiative would never happen. It demonstrates what can be achieved by a common focus and working as a team to overcome all of the hurdles and we at Design Cognition Ltd (DCL) are proud to have been involved in these Working Groups at ‘the cutting edge’ and having been personally involved myself, wish to offer my thanks to all involved for their support and mutual respect.

 As I’m sure you will appreciate, to implement successful Braille packaging solutions for the client there is a lot of work involved from a technical & aesthetic point of view, requiring much ‘horse-trading’ to ensure that the needs of all stakeholders are met. Luckily at DCL we have the skills to understand & empathise with these juxtaposed issues and for many of our clients have delivered Braille solutions inclusive of artworks in a timely, efficient and sympathetic manner that delighted them. If you’d like any further information on Braille or ‘hands on’ help from people that have practical experience and have been through the loop, check out: www.thepharmagateway.com/about and get in touch. (Anne Dallison)

 

A portable, talking barcode scanner from Matthews will make life easier for Australia’s vision impaired.

The scanner, known as ID Mate, can help the blind and low visioned at home, school or work — and even while doing the groceries.

ID Mate has been released by Visual Independence, a not-for-profit Australian charity set up to bring happiness through using assistive technology to those who are blind or live with low vision.

Visual Independence is managed through an all-voluntary advisory committee from Vision Australia, Guide Dogs Victoria, GS1 Australia and Matthews Intelligent Identification.

Visual Independence’s Bernie Slagtman says ID Mate is an exciting step forward that would allow the vision impaired to become more independent and empowered in their daily lives.

ID Mate uses Omni directional technology to scan an item’s barcode. Users then listen to spoken descriptions from the scanner’s database, which holds details of more than one million Australian bar code products.

via Talking barcode scanner from Matthews.

PACKAGING AND LABELING HELP FIGHT DRUG COUNTERFEITS

In the U.S.Food and Drug Administration’s ongoing battle against counterfeit drug products, the latest FDA guidance is aimed directly at packaging techniques.In a July guidance document to industry, the FDA set forth some suggestions for incorporating so called “physical-chemical identifiers” PCIDs into solid oral dosageform drug products and paid particular attention to those that might migrate from packaging or container labeling.The FDA defines a PCID as a product with some unique physical and or chemical characteristic that is added to the dosage form of a drug product and which “makes it possible to detect and authenticate legitimate dosage forms and identify counterfeits.”These so-called PCIDs can include inks, pigments, flavors, or molecular taggants, says the FDA. And the agency expects that many of them would be made of existing substances used in food additives, colorants, or drug products’ excipients.The FDA’s guidance document, entitled “Incorporation of Physical-Chemical Identifiers Into Solid Oral Dosage Form Drug Products For Anticounterfeiting,” is primarily concerned with helping drug makers and applicants for new drug approvals incorporate relevant information about their PCIDs into new drug applications, supplemental applications, and annual reports submitted to the FDA.The guidance does not attempt to address radio frequency identification RFID.Counterfeits have tended to be a bigger problem overseas than in the U.S., though it is a concern here, and not just when drugs are imported. The FDA has always recognized the importance of packaging technologies as potential solutions, including but not limited to RFID.Confirming the authenticity of any individual package of drugs, or, when possible, even an individual dosage, is the essence of thwarting counterfeits. In the complex distribution network through which drug products travel, opportunities abound to introduce counterfeit product into the mix.Counterfeits can come in many forms. For example, they might be products that are just imitations, and literally lack the right ingredients, or are out-of-date versions of the real thing, or are otherwise diverted from the ordinary authorized distribution pathways. It is a recognized phenomenon that authentic and appropriate products are often mixed with inauthentic counterfeits, meaning the confirmation of authenticity often involves measures going to the individual dosage level. Hence, ideas like PCIDs.As for PCIDs that are added to packaging or labeling of drug products in solid oral dosage form, the FDA makes specific recommendations on how to evaluate toxicological concerns and offers guidance on when and how to report or request approval of the addition of a PCID. The agency points out that, as expected, its “toxicological concerns are mitigated if the added substances is a permitted direct or indirect food additive,” or listed in the FDA’s Inactive Ingredient Guide.If the substance you want to use as a PCID in packaging is not the subject of known toxicological information, the packager should, says the FDA, determine that there won’t be migration of the substance into the products. If some interaction of the PCID with the product is expected, and toxicological concerns may result, the FDA suggests packagers contact the agency to discuss the issues. If the toxicology of the substance hasn’t been established, and the potential for its migration exists, the FDA says the drug product with that PCID in it would require a prior approval supplement before marketing.When it comes to PCIDs in solid oral dosage-form products, the FDA is hoping to help industry follow one of its key pieces of advice: Use a multifaceted approach to counterfeiting in order to stay at least one step ahead of counterfeiters.

via Healthcare Packaging – December 2009 : ANTI-COUNTERFEITING: WHEN PACKAGING AND LABELING HELP FIGHT DRUG COUNTERFEITS.

Drug approvals from the Food and Drug Administration were flat last year compared with 2008 and warnings fell, even as the agency’s new leadership struck a tougher stance on safety.

The FDA approved 26 first-of-a-kind prescription drugs last year, up slightly from 25 in 2008, according to figures from Washington Analysis, an investment research group. New drugs cleared in 2009 included Novartis’ kidney cancer drug Afinitor and Bausch and Lomb’s pink eye medicine Besivance.

Chris Penfold – there are a number of reasons froi this trend, one of them being a reduced number odf applications – so we can’t read too much in to this report.

Sourced from Pharmaceutical & Medical News, 6th January 2010 – Washington, USA

Read the full article at: Pharmaceutical & Medical Packaging News

States News Service, 29th December 2009 via www.packagingdigest.com

(Relating to information released by the National Association of Convenience Stores in the US)

With the growing popularity of caffeinated foods and beverages – recent years have seen the introduction of caffeine-infused chewing gum, drinks and potato chips. The Los Angeles Times has reported that, due to health concerns, some health experts have proposed introducing labelling standards for caffeine.

It is believed that there is a need to educate consumers about caffeine’s effects on the body, which according to  James Lane, a professor of medical psychiatry at Duke University Medical Center, can lead to problems such as attention deficit disorder, hyperactivity, high blood pressure, and insomnia.

Personally I think that this is a sound initiative, being proposed for the right reasons, although it will inevitably lead to further problems of text fit onto already cramped packs. What do you think? Chris Penfold

You can read the full article at: The Packaging Digest

The normal packaging development  process would involve firstly developing a pack to fit the product in an optimum manner. Then any legally required text would be positioned (including any required symbols, such as recycling logos). Finally the marketing requirements would be implemented, in terms of claims, branding etc. More often than not, there is then a need to go back to product marketers to get them to reduce their marketing copy on the packs, because it simply won’t fit……..and the situation is getting worse!

Other options that can help tackle this problem are:

A, reducing the font size – but this can have implications on readability, print process constraints and there is often a legal minimum size which needs to be adhered to.

B, Using paginated label leaflet formats – where, on occasions, we have developed up to a 10-page concertina style leaflets. However, these multi-layered add-ons can add a huge on-cost onto the price of a pack – for which marketers don’t always want to pay.

C, Printing on the inside of pack (e.g. cartons) – but not visible until a pack is opened. So one can’t do this with certain text which needs to be visible at time of purchase

D, Finally, if all else fails, considering increasing the overall size of the packaging.

An example of a multi-page label solution

This latter route is sometimes unavoidable, especially with pharmaceutical packs, where the packs are very small, and even after taking measures such as reducing the bar codes from 13 digit to 8 digit, there is simply not enough room to display the mandatory legal minimum required text (let alone any marketing text).

Furthermore, it is now the law for any new medicines to incorporate Braille on the packaging (it will be a requirement for all existing medicines by October 2010). This will have to detail the product name, the strength [of the medication] and the dose form – yet another constraint to bear in mind. New products also have to conform with the readability guidelines which are in place to ensure that the packs can be read clearly and understood by the patient/consumer).

It’s worth remembering that it’s not just the basic information that one has to put on the pack. Very this has to be repeated it in a number of  different languages. It’s not unusual for a European product to have a need for 12 languages. And then there might be a need to repeat ‘country of origin’ for every language, and could require five countries needing to be listed (for a range of ingredients). The result could be a situation where  all one has room to display is a list of ingredients  & addresses, and any wish for aesthetic beauty just ‘goes out of the window’.

At Design Cognition, we review the whole space to find an ideal design that looks most aesthetically appealing and hopefully doesn’t look too cluttered – but it’s not always easy!

Incorporating logos of different colours, or trying to mix varying colours of text with backgrounds, can add its own issues and problems. Sometimes ‘house colours’ do not lend themselves to readability, White text on a pastel or black background for instance, can be even harder to read, so we may need to redesign [the pack graphics], using the principles and processes detailed above.

Overall our job is to develop a pack that is fit for purpose and not over-packaged. Things are becoming increasingly challenging but, so far our use of creativity and lateral thinking has provided a suitable solution.

Moving forwards technology could aid some of the issues raised above. Nowadays, certain consumer/marketing information can be shown ‘on-line’, cutting down the need to put it all on-pack – maybe just a web address for further information. There have also been great leaps forward in microchip technology which will enable ‘talking packs’, ‘moving pictures’ and a whole new interactive consumer experience – taking packaging to a new level. These are all areas in which Design Cognition has a strong interest and is working with a number of suppliers to develop cost-effective solutions.

If you’d like more information on these areas, sign up for further information HERE

Chris Penfold

Below is a really interesting technological packaging advancement that is truly exciting and could have major benefits in the healthcare and pharma packaging & clinical trials sectors. Design Cognition also believe that this technology has further application in other dosage forms and sectors and is working with DSM TCG & GP Solutions (UK) Ltd to develop the OtCMâ„¢ and Dose Guardâ„¢ technologies in innovative ways to meet the demands of end-users and industry and bring this product to market in a viable & cost-effective manner.

Please contact me (chris@designcognition.com) if you’d like more information or come and visit us at Packaging Innovations at the NEC, Birmingham UK on 24th or 25th Feb (stand 582), where we can discuss in more detail. You can register HERE.  Chris Penfold

When was the last time you forgot to take your medication? Odds are that it was within the last week. This makes you part of the millions of patients who don’t take their medications as prescribed by their physician. Medication non-adherence, or mal-compliance, as it is commonly called, is a problem that disrupts the healthcare system in many ways. If you don’t take your medication odds are that you won’t get the full benefit of the treatment. As former US surgeon general Dr. C. Everett Koop said, “Drugs don’t work in people who don’t take them”. In the worst case, you could be among the patient population who are hospitalized as a result medication non-adherence. The cost to the healthcare system? Phenomenal! Mortality count? Sinister! Morbidity rates? Unacceptable!

At its root, this problem, like many, is a problem of human behaviour. Even Hippocrates (460-377 BC), the “Godfather of Medicine”, gave early warnings of the non-compliance issues to his students and colleagues. (”Keep watch for that fault in patients which makes them lie about the taking of things prescribed.”). Even though we are “creatures of habit”, we often lose momentum when taking medications, especially for chronic conditions.

The Non-Compliance Money Waste List

There have been several attempts at using technology to influence compliance rates. As one scans the Web looking for potential help, some solutions that arise include:   (1) A variety of medication reminders that will beep, blip or blurt when it is time to take your medication. (2) A variety of devices that can track the number of times a medication dosage has been removed from a medication pack or a medication container (USA) that has been opened. The data collected can be downloaded at the doctor’s office or pharmacy to check compliance statistics. (3) A variety of devices that can remind the patient to take their medications and confirm that they have taken it by pressing a button to send the data.  (4) A miscellaneous group of reminder devices with alarms, like automated pill boxes or wrist watches.

OtCM™ -  Objective therapy Compliance Measurement.

One of the weaknesses of these approaches is that one can never guarantee that the patients have taken their medicine after an alarm. In fact, one can’t detect if the medication unit dosage has been taken, or if the medication unit dosage has even been taken at the right time.

A new technology has arrived that has the potential to dramatically impact the therapy compliance rates for individuals, particularly seniors, as they go about their daily lives. The name of this technology is OtCM™, Objective therapy Compliance Measurement, using the most recent RFID/NFC (Radio Frequency Identification, Near Field Communication) technology, including embedded sensor functionalities, and combined with printed organic electronics.  The OtCM™ application was invented by Jos Geboers and Willem Kort, who are working in the healthcare industry, especially in clinical pharmaceutical R&D, Health Economics, Outcomes Research and Patient Recorded Outcomes.  To that purpose Messrs. Geboers and Kort initiated the foundation of a consortium that includes all players, i.e. top listed pharmaceutical companies, medication packagers, health insurers and Royal DSM N.V.: “The Compliers Group” (DSM TCG).  DSM TCG wanted a way to be as certain as possible that patients were taking their medications at the correct frequency each day. They knew that, whatever solution they decided on, it needed to be “real time” since any delays in therapy could have serious health consequences. A novel system for measuring the time and quantity of drugs taken out of conventional, existing medication packaging or medication container, is used.  “Leading” versus “Bleeding” edge …

The existing medication package will do …

The system consists of conventional, existing medication blister pack (or “bottle”) of a given prescription drug furnished with “organic electronics” (circuitry, power supply), i.e. functional polymers and coatings, to print “the micromechatronic blister/bottle”. A “traditional” silicon RFID/NFC IC (Integrated Circuit) that has been especially designed for OtCM™ with integrated interfaces for i.e. clock and temperature functionality, provide the intelligence to identify data (date-time) of pills/capsules that have been taken out of the blister pack/bottle, whilst wireless Radio Frequency (RF) techniques (NFC, Near Field Communication) are able to transfer data wirelessly from the “OtCM™ enabled blister/bottle” onto DSM TCG’s webserver.

Driven by the intelligence of the RFID chip, embedded in the “mechatronic circuitry”, and the printed power supply (capacitator, battery), an electric current is circulating through the circuitry of the packaging at regular time intervals. As soon as a dosage is removed out of the packaging, the chip is activated. This information is stored. When in close proximity of a (NFC) reader,  the recorded information in the packaging will be transferred and stored in the server to populate the Therapy Compliance Database of active patients, under all regulatory recommended & required security and privacy conditions, locally and globally.

The standard existing medication blister package will do at a fraction of the traditional costs!

The concept of using the technology of printing functional polymers and coatings is an innovative approach. A large variety of  applications in real-life situations has been brought about, especially for purposes of identification of products and, consequently, the packaging of products.  The standard medication blister package will do at a fraction of the traditional costs!   Moreover, until now, traditionally available therapy compliance devices are extremely costly, even if mass-produced. Mass produced RFID-tags combined with polymer printing will introduce low-pricing schedules, based on factors of 90-95% reduction vs. currently available “traditional electronic” OCM devices, i.e. pill boxes or so-called “smart pill boxes”.

DSM TCG’s OtCM™ technology can be combined with GP Solutions (UK) Ltd’s patented and approved Dose Guard™ solution; a child resistant senior friendly secondary barrier that when applied to a blister pack will render it safe for use. Both “come with the standard, existing medication package”.  From surveys it has been identified that patients and health practitioners (physicians, medical specialists, pharmacists) only appreciate the enabling of OtCM™ right from the medication packaging. There obviously is no need for an additional, “stand-alone” therapy compliance measurement (recording) device separated from the medication package.

During OtCMâ„¢ we measure through the standard medication packaging:

(1) when the pill/capsule is taken,

(2) the location of the removed pill/capsule onto the blister packaging,

(3) the correct dosing schedule,

(4) an acoustic signal might prompt the for action,  data re: expiration date,

(5) production information re: temperature, batch IDs from the production line,  drug interaction alerts.

This real-time “interventional approach” is what stands apart from other compliance solutions.  In conclusion, it is clear that there are several technological approaches that are aimed squarely at the problem of medication compliance. Though these advances give our “inner geek” some encouragement, they are ultimately targeted at making sure that at-risk populations stay on track as they take medications to improve their health status. David Rosa, Willem Kort

You can find further information on compliance and evolving technologies, via Design Cognition’s sister site ‘The Pharma Gateway‘. Also, if you are interested in our forthcoming compliance workshops – let us know.

Contact Chris Penfold (chris@designcognition.com).

A researcher at Massachusetts Institute of Technology (MIT) who used to be a brand manager at luxury goods firm Louis Vuitton Moët Hennessy (LVMH) asked hundreds of fake bag buyers about their habits in an unpublished study ‘The Real Value Of Fakes’.

Renee Richardson Gosline interviewed the consumers who knew when they bought them that the bags were fakes and found that 46% of them bought authentic branded bags within two years.

“For some status-seeking people, at least, the social power of luxury goods means that consumption must not just be conspicuous, but real,” said a statement from MIT describing the research.

“The counterfeit actually served as a placebo for brand attachment,” Gosline told news service Bloomberg . “People were becoming increasingly attached to the real brand even though they never possessed it at all.”

You can read the full article here: OUT-LAW New

You can find further information on counterfeiting and evolving technologies, via Design Cognition’s sister site ‘The Pharma Gateway‘. Also, if you are interested in our forthcoming counterfeiting workshops – let us know.