Wouldn't it be nice to know how to deal with and PREVENT audits?

It's not a surprise that regulations drive company strategies and the solutions/processes they implement. The pharmaceutical supply chain may be unique with the number of regulations that need to be followed, depending on where, how, and what you are shipping.

If you are going through the Canadian distribution networks, you need to have a complete understanding of Health Canada's Regulation 0069 and what it entails. However, Health Canada is due to release updates to their guidance in early 2011. The focus of these changes is to strengthen control in an end-to-end cold chain.

We're really excited that Sarah Skuce, Compliance Specialist at Health Canada will be reviewing the updates to GUI-0069 during the 9th Cold Chain & Temperature Management Summit in February in Toronto. Also, for the first time ever, Sarah will lead a pre-conference workshop to help the bio-pharmaceutical industry understand these changes. This will be a great opportunity to finally sit down with Health Canada and dissect actual case studies of inspections, audits and overcome their temperature control challenges!

More info about this workshop and presentation is available on our website.

Also, Sarah provided us with an article on Health Canada’s Guidelines for Temperature Control of Drug Products during Storage and Transportation

Cold Chain on "Today in America" - Emerging Temp Control Management Trends

“Today in America,” hosted by Terry Bradshaw, will feature a five-minute segment on emerging cold chain management trends and technologies. It will air nationally on the FOX Business Network and in 19 major regional markets on CNN Headline News.

“The timing for the national exposure couldn’t be better,” said featured segment participant Matty Toomb, American Thermal Instruments (ATI) Vice President - Sales & Marketing. “Businesses are looking for greater efficiencies and cost savings, and at the same time, there’s more emphasis on accountability and compliance with regulatory issues in the cold chain.”

In addition to ATI, Minnesota Thermal Science (MTS), is also featured in the clip.

Watch the complete clip!

We welcome your comments and feedback on the segment and hope you'll catch it live when it airs as well!

The complete press release by ATI is included below:

Trend-Setting Technology Results in National Exposure for American Thermal Instruments

DAYTON, Ohio – September 17, 2010 – American Thermal Instruments (ATI) will be featured in a nationally broadcast video on emerging cold chain management technologies. “Today in America,” hosted by Terry Bradshaw, highlights the latest technological trends impacting people and businesses. The five-minute segment featuring ATI will air nationally on the FOX Business Network and in 19 major regional markets on CNN Headline News.

While ATI manufactures a broad range of temperature monitoring devices, it’s LOG-IC® wireless RFID technology is the primary focus of the “Today in America” broadcast. Brad Proctor, Executive Director & CEO of Dayton RFID Convergence Center, a business incubator, explains in the segment that visibility into the cold chain provides critical cost advantages today. Referencing LOG-IC, Proctor said, “this product is probably two years ahead of anybody else out there in the field.”

LOG-IC has been attracting the attention of the pharmaceutical, food, medical and chemical industries due to its ability to offer advanced temperature monitoring quickly and cost-effectively. “The timing for the national exposure couldn’t be better,” said Matty Toomb, ATI Vice President - Sales & Marketing. “Businesses are looking for greater efficiencies and cost savings, and at the same time, there’s more emphasis on accountability and compliance with regulatory issues in the cold chain.”

The broadcast also highlights the recent strategic partnership between ATI and Minnesota
Thermal Science (MTS), an international provider of solutions for transporting temperature-sensitive pharmaceutical, blood and biologic products.

LOG-IC technology will become an integral part of the MTS Credo® line of thermal shipping containers. In the broadcast, Karl Schlenker, MTS Vice President of Strategic Business Development explains the challenges of shipping temperature-sensitive materials and the significance of the partnership. “The two products working together now allow us to deliver the product, but also verify and maintain that there’s never been any excursion,” he said.

ATI and MTS both exhibited at the 8th Cold Chain Distribution for Pharmaceuticals Global Forum in Philadelphia, September 20-23, 2010. Attendees had the opportunity to view these trend-setting products and technologies and gain further insights on the benefits. In addition, registered attendees will receive an email with a link to the “Today in America” video. The video is posted on ATI’s website at http://www.americanthermal.com/ati/index.cfm/products/logice284a2/feature-story-on-log-ic-and-ati/

To learn more about LOG-IC and ATI’s complete line of temperature monitoring products, visit www.americanthermal.com.

Contact:

Matty Toomb
mtoomb@americanthermal.com
2400 East River Road
Dayton, OH 45439
937.429.2114

Over the past year, we worked with several participants of the 8th Cold Chain Distribution for Pharmaceuticals Global Forum to deploy a survey to understand and improve the handling of temperature controlled medicines during the 'last mile' before reaching the patient. We received survey responses from pharmacists, healthcare providers, pharmacy operations, and many others involved in the 'last mile'. The results from the survey were quite interesting and we thought we'd share the results.

We asked: What do you think the pharmaceutical industry could do to help?
Answers were:

• By being more consistent between manufacturers for the same product (ie. all manufacturers should have the same expiration dating even if it is slightly shorter to keep it the same.)
• Establish allowable shipping excursion limits (understanding mail order practices) and attaching temperature indicators
• Increased public awareness through education in simple, easily understood terms
• Continue to support improvement in technology, possible smart tag which would monitor not just accountability, but product information to assist and support patient adherence (compliance) technologies as well as monitor environmental conditions and potential impacts on product integrity
• Revisit product packaging design, blister packaging may better protect product, be more compatible with adherence tech, etc
• As a home health IV pharmacy technician, I only became aware of the cold chain process through research. When I first started at my current position, the shipping of refrigerated product was far different than it is now. Anything the industry can do to promote awareness is very important
• Temperature indicators on there product and descriptions on the effects of improper storage conditions
• Know the excursions times and impacts on the product
• Provide excursion data to pharmacies and/or provide recommended shipping containers that will ensure the integrity of their products
• Label packages with chemical temperature controls
• Do more studies for a wider range of temperatures. For refrigerated items, do studies involving what happens if product is exposed to freezing temperatures
• Better labeling
• Provide data on out of range temperatures
• More explicit information when temperature storage requirements are not met

What else can the pharmaceutical industry do to help pharmacists and healthcare providers? Weigh in and take the Healthcare Cold Chain survey!

Are "cold chains" only cold?

The stereotype is that we only talk about 2-8 degrees C at the Cold Chain Distribution for Pharmaceuticals Global Forum. More and more each year, companies are focusing on overall transportation strategies as a part of their global logistics. Most drugs are temperature controlled in some way - whether it's 2-8, 8-15, CRT, ambient, ultra-cold or some other temperature profile. And if the product isn't temperature controlled, it's still important to understand trends in supply chain management.

The major challenges for a cold chain hold true for all distribution operations:

• Transportation and import/export security
• Devising contingency plans with transportation partners
• Quality management of air freight
• New RFID technology offering visibility through all legs of the chain
• Green packaging initiatives to reduce footprint

Many people have speculations about the future of temperature controlled supply chains. One recent report by Pharmaceutical Commerce estimates that "7 of the top 10 global pharma products in 2014 will require cold-chain handling." So cold processes are becoming an integral part of any operations. But, there are still many practices and learnings that we can share across temperature profiles.

If you want more information about cold, ambient, CRT or other temperature profiles, check us out at www.coldchainpharma.com.

Air Cargo 201 - Part 2 of an "Interview with an Airline"

One of last year's highest rated sessions at the Cold Chain Distribution for Pharmaceuticals was the "Interview with an Airline" panel discussion. The discussion gave airlines a voice on how they are handling temperature-controlled pharmaceuticals and the manufacturers had a clear understanding of what best practices airlines adhered to.

With IATA Chapter 17 deadline just passed (in July) and TSA Cargo Screening deadline quicly approching (August), there are still many questions on how much the supply chain has really progressed. Have these regulations made an impact on operating a complex cold chain in the air? And what about on the tarmac? Is it really reasonable to expect agents to adhere to these new guidelines? How do manufacturers have to adjust their procedures to comply?

This year at the Cold Chain Distribution for Pharmaceuticals, we'll host Part 2 of the Interview with an Airline during the AIR CARGO 201 seminar. A new panel will address the above questions with specific examples from different parts of the world (ex India, Doha, Chicago, Dublin, London and Japan). Participating organizations include: IATA Time & Temperature Task Force, Exelsius Cold Chain Management Consultancy, United Cargo, American Airlines Cargo, Continental Airlines Cargo, Genzyme and the Air Forwarders Association.

Here's some background on our panelists and what they'll be bringing to this year's discussion:

Mark Mohr of Continental Airlines Cargo brings experience on balancing supply/demand for key customers and shipping temperature control cargo daily to Israel and India, relaying overcoming certain infrastructure developments at airports and at freight forwarder warehouses.

Roger Samways of American Airlines Cargo will talk about shipping to Latin America and the importance of front-end planning and communications among supply-chain partners for successful outcomes.

Don Harrison of United Cargo and member of IATA's Time & Temperature Task Force brings first-hand knowledge on what goes into re-writing Chapter 17 of the Perishable Cargo Regulations.

Brandon Fried, Executive Director of the Air Forwarders Association will provide the freight forwarder perspective of filling gaps in effective shipping of temperature sensitive pharmaceuticals by air. His view includes how to effectively select a forwarder suited to your needs in shipping temperature controlled consignments while dealing with government requirements including air cargo screening on passenger aircraft.

Larry Sweeney, Senior Director, Distribution and Logistics, Genzyme will give a perspective on what's important to the pharmaceutical manufacturer to see airlines changing and improving post IATA Chapter 17 implementation.

If you'd like to submit questions to this panel, be sure to email them to us and we'll make sure they are answered at the event!

How are pharmacists involved in ensuring stability of temperature controlled pharma products?

During program development of the 8th Cold Chain Distribution for Pharmaceuticals Global Forum, many people told us about the recent focus on ensuring stability of temperature controlled medicines during the 'last mile' of distribution before reaching the patient. Recent guidance, including the PDA's Technical Report 46 on 'last mile' best practices, have reinforced this focus by the entire industry.


Specific questions that came up in our research were:

• How do pharmacists communicate temperature requirements to customers?
• How important do pharmacists and physicians feel it is to maintain the product at the storage conditions specified on the label?
• How do pharmacists and physicians ensure that products are stored at the correct temperatures while in the pharmacy?
• What additional needs to pharmacies have that would assist in maintaining temperatures? How can the pharmaceutical industry and interest groups help with these needs?

Give us your input on these questions by taking our survey at www.coldchainpharma.com/survey.

Want to learn more about controlling the distribution process through pharmacists and physcians or get a survey results summary? Find out how at www.coldchainpharma.com/survey.

Welcome to the Pharmaceutical Cold Chain Blog!

This blog will feature news and events about safely distributing temperature-sensitive pharmaceutical products and how to develop strong collaborations with cold chain partners and other stakeholders. For more information, best practices and strategies, check out the 8th Annual Cold Chain Distribution for Pharmaceuticals Global Forum.

Please check back often for updates and leave comments, suggestions and questions if you would like.