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)

 

Confusion still reigns over the use of food packaging containing Bisphenol A.

The food standards agency in Australia and New Zealand seem to think that the risk is ‘very low and does not pose a significant health risk’

The Food and Drug Administration in America announced on Friday last week that they feel it’s use is ‘now of some concern’ – they would like to see it’s used phased out in the food and drink area.

The European Food Safety Authority has said that it wants to discuss the FDA’s announcement and the UK Food Standard Agency says that it’s position remains unchanged and feels that the amount of BPA in food packaging “is well below levels considered harmful.”

Looks like this subject could carry on rumbling for quite a while before a consensus is reached – in the meantime, it might be best to ensure any new food and drink products you develop/launch have packaging that doesn’t contain BPA (Jane)

via EFSA to evaluate FDA decision on bisphenol A.

via Bisphenol A (BPA) and food packaging (January 2010) – Food Standards Australia New Zealand.

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

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.

Sounds like there will be a lot of artworks that will need changing – I hope the smaller businesses out there fully understand the regulations (Jane)

Canadian manufacturers of antiperspirant products have until the end of 2011 to alter product claims and labeling under new regulation. Following new guidance on the classification of products on the cosmetics drug interface, aluminium containing antiperspirants are now classified as cosmetics in Canada.

via Antiperspirant labels and claims change in Canada.

Does this apply to any of your products?  This new ruling comes into affect on the 18th November 2009 and all new products entering the market need to be compliant by November 2011. (Jane)

The European Commission has changed the labelling requirements for formulations that contain certain hair dye ingredients. Amendments to the Directive are in response to a conclusion from the Scientific Committee on Consumer Safety SCCS previously known as the SCCP – Scientific Committee on Consumer Products that said contact allergies caused by hair dyes are an increasingly important health problem. These types of reactions can cause ‘acute and severe dermatitis’ in affected individuals, according to the SCCS. In an attempt to better inform the consumer of these dangers, the Commission has altered the warnings that must be included on the labels of oxidative hair dye products and some non-oxidative products that contain strong sensitising substances. 

via Cosmetics Directive amended to flag up hair dye allergy dangers.

www.cosmeticsdesign.com

It has been mandatory to include Braille on all new EU Marketing Authorisations since 30th October 2005.

According to Article 56(a) of Council Directive 2001/83/EC it will be mandatory to include Braille on ALL EU pharmaceutical packaging by October 2010. This includes pharmaceutical products which were launched prior to October 2005.

Braille must show the name of the medicine and the appropriate strength, where more than one strength is available.

Braille alphabet

Support for Braille introduction
At Design Cognition we take the implementation of Braille very seriously. That is why our Chief Technical Officer Annie Dallison volunteered to be a member of The European Committee for Standardization (CEN) working group on Braille standards. Annie, as a leading industry expert, already had over 8 years of experience in the application of Braille on pharmaceutical packaging developing processes and establishing & setting standards for blue chip companies, making her an ideal member of the working group.

CEN working group
This CEN working group is made up of dedicated representatives from the packaging industry, trade associations, regulatory bodies and blind associations from across Europe.

This group has been working for over 3 years to determine and agree standards, including the Braille font style (Marburg medium) and measurement of Braille cell dot height that can be applied across the whole of the EU. One of the main issues for the team has been reaching agreement on the cell dot height that the blind associations feel will be sufficient to meet the needs of the blind users and also industry believe is commercially achievable. The final standard will hopefully be available before October 2010.

If you’d like find out more and how to avoid breaking the law, get your FREE ‘Introduction to Braille’ follow this link:

http://www.thepharmagateway.com/

If you are going to AAPS in Los Angeles, November 9th-12th, why not come & visit us at ‘Booth 1962′ to discuss this in more detail? See you there!

Chris Penfold