As we move into the second week following the Haitian earthquake, things have been fraught for the local population, most of whom have been without food, water, electricity, or a roof over their heads. During that period dead bodies have been piling up all over the place, including hospital car parks where medical supplies have been in short supply and many of the surgical operations that have been carried out, have been done without anaesthetic.

Medical, food & water supplies packaged to survive a harsh environment

Although of no consolation to those that have perished over the past week, luckily the logistical situation is improving now that US ships have arrived and helicopters are finally getting to the places they are needed with those essential supplies. It is at times like this that we are reminded of the true worth of packaging,  in an environment where there are no fridges to keep things cool and packaging has to perform an even more essential role than normal in a very hostile environment. The packaging contains, avoiding spillage. It protects against crushing, vermin & pilfering. It preserves, providing protection for the products within and extended shelf life. It enables ease of transport, whether by plane, truck or onwards by hand and lastly it informs, providing vital information on contents, storage, dosage and application.

In summary, it provides a lifeline where, without it, medical supplies would arrive dirty and non-sterile, food would ’spoil’ within hours and water would become contaminated, leading to dysentery and further distress and trauma. So, packaging, where on earth would we be without it? Chris Penfold

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

NOTTINGHAM science companies will lead a delegation of UK firms pitching for business during one of the biggest events in the American pharmaceutical industry’s calendar.

Businesses from the city account for one-third of the firms in the English delegation attending a reception during the American Association of Pharmaceutical Sciences (AAPS) annual meeting in Los Angeles.

They will meet potential customers and investors next week at an event hosted on their behalf by the British Consul in LA, Dame Barbara Hey.

The Nottingham firms taking part in the 20-strong delegation are Critical Pharmaceuticals, Design Cognition, Food and Drug Analytical Services, Molecular Profiles, Pharmaceutical Development Services and R5 Pharmaceuticals.

The US pharmaceutical market is the biggest and most lucrative in the world, with companies bidding for work in a field where the biggest firms routinely outsource research, development and service work to smaller companies.

Some of the Nottingham firms will be going to link-up with existing contacts, while others, such as specialist packaging and product development firm Design Cognition, are first- timers. Chris Penfold, the company’s chief executive, said: “We are on a fact-finding mission, to learn as much as possible about the US market and assessing where and how we can add value for US pharmaceutical companies looking to export, through our understanding of packaging requirements and regulations of global markets.”

His company is working closely with Pharmaceutical Development Services, which already has an office in the US state of South Carolina, another industry hotspot.

“Making a move into the US requires a great deal of market as well as regulatory intelligence,” said managing director Michael Gamlen.

“Close working relationships and collaboration are key to success and our respective consultancy services dovetail perfectly to add potential value for US companies.”

To read the full article, click here: http://bit.ly/Ox0hr

Watch this space for further information as I will be following up with This is Business- East Midlands (Nottingam Evening Post) after the AAPS event.

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

Published By James Quinn, Daily Telegraph, 26 Oct 2009

Save for the economy, in the first year of Barack Obama’s presidency the issue he has spent the most time on has also been the most contentious – the future of healthcare.

As he tries to right the failings of several of his predecessors, the US president’s push to increase healthcare provision for the 20pc of Americans without health insurance – at the same time as not overly increasing the burden on taxpayers – is a difficult task.

With the US budget deficit at $1.42 trillion, the $829m (£506m), ten-year cost of the Senate finance committee’s bill – the main one of five pieces of legislation President Obama is to attempt to meld together in the coming weeks – may just be too much to bear.
Whatever the outcome, however, it is clear that the $2.3 trillion-a-year US healthcare industry offers significant opportunities to make money.

For British companies, the sheer breadth of the market – with its regionalised approach and the power of private medical insurance companies – might be unnerving, but in fact offers clear advantages, as Nottingham, UK  based Design Cognition hope to capitalise on over the coming weeks as part of a UK Trade & Investment (UKTI) “mission” to the American Association of Pharmaceutical Scientists (AAPS) in November.

If you are a company that want to launch your pharma products into new markets but are confused by packaging requirements & regulations, find out more about how Design Cognition can help at www.thepharmagateway.com

Design Cognition is also looking for individuals /companies that can provide collaborative support ‘on the ground’ in the US to help facilitate entry into the US pharma market. For further details contact Chris Penfold, Chief Executive.

You can read the full Daily Telegraph article here: http://tinyurl.com/yg2pkoc

Chinese funding to cut specialist food packaging imports – worrying trend?

By Rory Harrington,

A Chinese packaging company said it is to receive multi-million dollar government funding to expand its operations and reduce domestic reliance on specialist packing imports.

Shiner International announced this week that the development of its Packaging Industrial Park project in Hainan will be part-funded by a government grant of RMB 29m ($4.26m).

Domestic boost

The company, which specialises in food safe and anti-counterfeiting packaging, said the cash will be used in the construction of a new facility. The Chinese Government gave the green light to the funding because the plant will help domestic food manufacturers reduce their reliance on having to buy specialist film packing applications from overseas, said the company.

Shiner CEO Jian Fu said: “For quite some time, the Chinese domestic market has relied on the importing of high quality packaging films for high-end consumer products at great expense to Chinese manufacturers. In recent years, the central government has begun to realise the importance of domestically developed key technology products that utilise intellectual property that is developed and owned by Chinese companies such as Shiner.”

Funding for its packaging project will allow the Chinese outfit to make its patented products in a state-of-the-art facility, he added. The money will be used for construction of infrastructures, improvement of capacity and recruitment of senior technical staff for the project.

via Chinese funding to cut specialist food packaging imports.

Interesting piece of work – watch this space (Annie)

Thursday, September 17, 2009

Going live – EFPIA pilot project makes debutIt was a rather soft launch in Sweden today, but an important moment for industry and patients.The EFPIA pilot project, testing a product verification system in pharmacy based on the use of a two-dimensional data-matrix went live today in Sweden. There was not an official ‘hard launch’ that will come, but earlier this morning three pharmacies began to use the system. Another 20+ will go live next week.

via EFPIA.