Pallet-Sized Shippers Target Global Transit

Growth in bio-engineered products more susceptible to variations in temperature and humidity. Emerging global markets that require packaging that will stand up to the handoffs, complexities, and climate variations of extended supply chains. The proliferation of guidelines and regulations from countries around the world promoting best practices for handling sensitive freight.

It all adds up to a “perfect storm” for manufacturers of thermal shipper solutions. 

Drug manufacturers’ requirements for new solutions in unit load devices (ULDs) has spurred innovation for stowing pallet-sized loads of various sizes in aircraft transport. 

“Customers are requesting a lot of international work, and looking for more payload capacity.  We are seeing a tremendous demand for longer duration shipments (in pallet-load sizes),” says Larry Gordon, president of Cold Chain Technologies. 

CCT plans to launch six new pallet-sized thermal shippers this year. A new GTS 6000 will handle product requiring room temperature conditions. Other of the company’s planned ULDs will feature smaller pallet dimensions for transit lanes served by planes that can’t accommodate full-sized pallets. 

EnviroCooler just launched a pallet-sized ULD designed to fill out an LD3-size cargo space, supporting more payload for the same transport cost. 

And leveraging its technology in ultra-low temperature containers for pharmaceutical product, Farrar Scientific is offering a ULD metal container with heating and cooling capacity. The PharmaPort 360 responds to customers’ concerns over ambient temperature extremes on global routes, reports Farrar Scientific president Scott Farrar. 

While improved packaging solutions go a long way, companies shipping to far flung destinations face exceptional challenges. Security check points in a post 9/11 world have added to the in-transit hurdles. 

Manufacturers are minimizing variability in supply chain logistics, streamlining supply chains with partners committed to best cold chain management practices. 

It will be interesting to see if quality assurance programs for sensitive drug cargo recently implemented by the airlines–perhaps in combination with new pallet load systems and thermal technology–will reduce the higher excursion risks historically seen in the air transport leg of shipment itineraries.

Dave Vaczek

Posted in Cold Chain | No Comments »

Covert Anticounterfeiting: Smart Strategy, or an Insult to Partners?

Patients in the United States are very lucky that drug and medical device counterfeiting has not caused the problems other global regions have seen. But as U.S. supply chains stretch around the world, especially pharmaceutical and medical device supply chains, will U.S. patient safety remain the norm?

According to a press release issued by BrandWatch Technologies, in 2009, U.S. Customs seized over $30 million in counterfeit medical products, including pharmaceuticals, personal care products, electronic components, and power systems. I searched the Web to verify this fact and found this statement “The U.S. pharmaceutical industry loses billions of dollars of annual revenues due to counterfeit medicines.  The average reported value of counterfeit medicines seized in 2008 was over $5 million” on the Web site of the Office of the United States Trade Representative.

Many numbers are being cited, but one thing is clear: Counterfeits threaten patient lives and corporate livelihoods. “The potential health risks to consumers aren’t the only dangers,” explains Steve Delepine, V.P. of Business Development for BrandWatch Technologies. “The effects of legal liabilities, negative branding, and revenue loss can ultimately bankrupt a company.”

Delepine is looking to help the medical device industry monitor for counterfeits particular, at several stages of the the product’s entire life cycle “from contract manufacturers, to healthcare administrators, all the way to the customer.” BrandWatch offers taggants for multiple uses, potentially in the inks, dyes, polymers, pulp, and paper used in packaging and labeling.

“Too many companies spend a lot of money on a security solution which will be duplicated or obsolete in six months,” Delepine warns. “A brand protection plan that doesn’t include an evolving design is no plan at all. Counterfeiters just move too fast.”

A security expert I recently spoke to (not from BrandWatch) indicated that as more and more companies outsource certain operations to contractors around the world, they are truly at the mercy of their partners. Of course, due diligence in selecting the right partner with a proven reputation should help eliminate risk.

But if a company is dealing with a new partner that may be outsourcing activities itself, would using covert protection unbeknownst to that partner provide extra protection? Is that a smart business strategy, or an insulting one, should your partner ever find out?

Daphne Allen

Posted in Counterfeiting, Healthcare Reform | No Comments »

Spotting Counterfeits: A Consumer’s Best Tool

Packaging is being called upon to help consumers identify counterfeit Alli. Could you call upon your own packaging to help in the event of a counterfeit attack on your brands?

FDA updated its public health alert about a counterfeit version of Alli 60 mg capsules (120 count refill pack) being sold over the Internet, particularly at on-line auction sites, the agency reported. Alli is an FDA-approved over-the-counter weight loss drug that contains orlistat as its active ingredient. The fake product may contain unsafe amounts of sibutramine, the active ingredient of another FDA-approved drug.

FDA advises consumers to look for certain packaging and labeling elements that exist on authentic products. Counterfeit products are missing lot codes on the outer cardboard packaging, feature incorrectly formatted expiration dates, and lack the safety seal of the real product bearing the words “SEALED FOR YOUR PROTECTION” prominently printed on it. For photo examples, click here.

Have you built in unique packaging and labeling clues that could help consumers spot a fake version of your products?

Daphne Allen

Posted in Bar Coding, Counterfeiting, FDA, Hospital | 2 Comments »

Could MTM Be the Key to Healthcare Reform?

The National Association of Chain Drug Stores (NACDS) says that pharmacists play an important role in improving patient outcomes and saving healthcare costs. Could they help reform healthcare ahead of (or instead of) any legislation? Can you help them?

NACDS cites the briefing paper Medication Therapy Management: Catching Errors, Saving Lives and Money by the National Council of State Legislatures (NCSL), which explains the potential of pharmacist-medication therapy management (MTM) services. The paper notes that one in four Americans (about 75 million people) do not follow directions when taking prescription medicines. This can cost an estimated $290 billion annually in hospital admissions, extra doctor visits, lab tests, and nursing home admissions.

“As the face of neighborhood healthcare, pharmacy is uniquely positioned to assist patients in managing their health care, providing advice on how to take medications, screenings vaccinations and other pharmacy services. NCSL is demonstrating healthcare leadership by highlighting innovative strategies to help patients take their medications appropriately,” said NACDS President and CEO Steven C. Anderson, IOM, CAE. “These briefing materials often are important steps down the road to pro-patient policy decisions. We will continue to work with lawmakers at the state and federal levels to advance public policy that strengthens opportunities for pharmacists to offer MTM services for patients.”

The paper states that “many patients do not understand health information.” A lack of understanding can be especially problematic for chronic conditions. If compliance is low for expensive medications and patients bounce around from one regimen to another, treatment costs could rise, perhaps unnecessarily. NCLS believes that MTM for patients with such chronic conditions as asthma and diabetes could help contain costs.

Can you help support pharmacists with detailed packaging and labeling? Your efforts may not only help reduce healthcare costs, but it could help patients stick with your products and not switch another drug.

Can you share any packages that have made a difference?

Daphne Allen

Posted in Medical Errors, Medication Guides, Medication Therapy Management, Package Inserts, Safety | No Comments »

Healthcare Reform Could Now Depend on Voluntary Efforts toward Patient Safety

After Republican Scott Brown’s win in Massachusetts, political pundits are already predicting the failure of President Obama’s healthcare reform efforts. But even if the bill currently tied up in Congress fails to pass, healthcare reform does not have to end. In fact, if the bill does fail, maybe healthcare reformers can step up their focus on improving patient safety. Eliminating weaknesses in these areas could improve patient care and cut costs throughout the industry. But it will also require voluntary efforts on your behalf.

For instance, this month the Institute of Medication Safety reported that its survey of pharmacists and healthcare practitioners revealed current drug-stocking habits could affect patient safety. “One-third of respondents reported that economic conditions have resulted in less safe drug purchasing decisions, such as switching to multiple-dose vials instead of using single-use vials and prefilled syringes,” ISMP reports. “One-third of respondents also reported reduced availability of medications because their organizations had decreased inventory due to the economy. Many respondents who provided comments noted that they had even run out of frequently prescribed medications during the past year. A few suggested that new formulary restrictions have made important drugs unavailable without adequate therapeutic equivalents or substitutions.”

What can drug packagers do? Work to make single-use vials and prefilled syringes, which experts say can reduce administration errors, as widely available as you can. Invest in automation technologies and other manufacturing enhancements that can help you bring the costs down and maybe make them more affordable. Improve tamper evidence and add security to further protect patients.

Late last year, Institute of Medicine President Dr. Harvey Fineberg urged other efforts, such as developing fail-safe systems in hospitals and fighting hospital-acquired infections.  Are there steps you can take to help fight errors and infections through packaging improvements?

As I say above, voluntary efforts are required throughout the healthcare system. Collaboration is needed between drug and medical device manufacturers and high-tech packaging and labeling providers.  Investments will be required–but the resulting patient safety improvements and cost savings could achieve reform on their own.

Daphne Allen

Posted in Bar Coding, Compliance Packaging, Counterfeiting, Healthcare Reform, Hospital, Inspection, Labeling, Medical Devices, Medical Errors, Safety, security | No Comments »

Do You know Where Your Packaging Materials Are?

McNeil Healthcare’s 60-million-bottle recall shows that your responsibilities extend far beyond the package’s walls. Since 2008, McNeil has received odor complaints regarding certain Tylenol products. In 2009, McNeil began recalling bottled OTC products after discovering that packaging may have been contaminated with a pallet pesticide. The recall now numbers 60 million bottles.

If a pallet pesticide can leach into packaging components and contaminate a product (McNeil’s theory as to the source of the moldy odor), drug and medical device manufacturers clearly need to monitor their packaging’s packaging and beyond. That includes, of course, what your suppliers and contract manufacturers are using, too.

I am guessing that these packaging components weren’t loose on a pallet, so if such a chemical was the source of the contamination, it must have breached whatever container these components were stored in. Such a scenario has got to be pretty frightening, because it means you’ve got to ensure that storage conditions meet stringent requirements. How many do?

FDA may be asking you that very question. At a press conference on Jan. 15 following issuance of a warning letter to McNeil, FDA said it is looking into whether other companies could be using the very same chemicals and pallets.

If you are, what should you do? Are your products up to the smell test?

McNeil is recalling products well beyond those for which it received complaints. So, even if your products smell OK, are they OK?

Daphne Allen

Posted in Bottles, FDA, Recalls, Safety | No Comments »

Costs Dropping ahead of Healthcare Reform?

The Pharmaceutical Care Management Association (PCMA) said today that a growth drop in drug spending coincides with “cost-saving” tools promoted by pharmacy benefit managers (PBMs). These tools include the use of generic medications, e-prescribing, and mail-service pharmacies.

So are these programs behind the spending slowdown, as PCMA suggests?

“Expenditures on prescription drugs increased just 3.2% in 2008 – the smallest annual rate of increase in 47 years – according to new data released today by the Centers for Medicare and Medicaid Services (CMS),” PCMA reports in its press release. It points to data an article in Health Affairs, “Health Care Spending at a Historic Low in 2008,”  specifically:

·         Prescription drug expenditures increased 3.2% in 2008, the slowest annual rate of increase in 47 years.

·         Overall health care spending increased 4.4% in 2008, a higher rate of increase than prescription drugs.

·         Consumer out-of-pocket expenditures accounted for 21% of prescription spending in 2008, down from 31% in 1998 and 60% in 1988.

PCMA President and CEO Mark Merritt says that generic medications, e-prescribing, and mail-service pharmacies  improve savings, access, and safety for consumers and payers.

Can these connections be made? If so, support for such programs could continue to rise. Are you factoring these into your business plans for 2010?

Daphne Allen

Posted in CMS, Healthcare Reform | No Comments »

Revisiting Reimportation

At what cost could FDA be forced to change its tune on reimportation?

“The Administration supports a program to allow Americans to buy safe and effective drugs from other countries and included $5 million in our FY 2010 budget request for the Food and Drug Administration (FDA or the Agency) to begin working with various stakeholders to develop policy options related to drug importation.”

This statement was included in a December 8 letter to U.S. Senator Tom Carper from FDA Commissioner Margaret Hamburg in response to Carper’s letter regarding reimportation. Carper was apparently asking for FDA’s views on an amendment presented by Senator Byron Dorgan.

FDA still seems uncomfortable with the idea, pointing out potential patient risks. “The Dorgan importation amendment seeks to address these risks,” Hamburg admits. “It would establish infrastructure governing the importation of qualifying drugs that are different from U.S. label drugs, by registered importers and by individuals for their personal use.”

But to pull it off, FDA seeks some form of regulatory oversight over these foreign manufacturers, and it says it could be costly. Hamburg writes that FDA would need to review both data and facilities. (An initial $5 million seems hardly enough to get started.)

So, “as currently written, the resulting structure would be logistically challenging to implement and resource intensive,” Hamburg concludes.

Given this conclusion, would the potential savings from the imports themselves be worth the costs of increasing FDA’s budget to give it sufficient international oversight?

And with healthcare reform potentially raising “taxes” on manufacturers (or at least some sort of “support”), could U.S. drug manufacturers actually be forced to pay for reimportation?

Daphne Allen

Posted in Bar Coding, Compliance Packaging, FDA, Healthcare Reform, Reimportation, Safety | No Comments »

Speak out about Sustainability

A new task group has been added to the Institute of Packaging Professional’s (IoPP) Medical Device Packaging Technical Committee (MDPTC). The Sustainability Task Group was announced this month, with the intention of focusing on “the unique challenges sustainability brings to the medical packaging industry, reported MDPTC co-chairs Alison Tyler of Beacon Converters and Harold Reisman of C.R. Bard. The new task group will be led by Chairperson Michael Scholla, PhD, Regulatory Affairs Manager, DuPont Medical Packaging.

MDPTC’s examination of sustainability with a task group shows that the topic is penetrating mainstream business considerations. This past year Baxter and Abbott issued progress reports on sustainability initiatives. Edwards Lifesciences launched its own initiatives, and Don Krebs, CPP, senior packaging engineer, global packaging operations, will be speaking about the use of biopolymers at the upcoming Medical Design & Manufacturing West 2010 February 8.

Addressing sustainability while upholding stringent packaging standards could be challenging. Packaging professionals will have to reexamine long-standing company practices and processes, revisiting decisions made long ago and potentially validating new solutions. But changes will need to be based on more than just environmental considerations, given potential risks to patient and product safety.

You are invited to take part in the sustainability discussion by joining the group. If you are interested, please e-mail Karen Greene.

Other MDPTC task groups remain active, and their progress will be shared at the committee’s meeting at HealthPack 2010 in San Antonio, TX, March 2-4. These groups include the Labeling Task Group, led by Chairperson Dave Olson of Advanced Web; Industry Standards and Regulatory Activities Liaison, Chairperson Hal Miller of PACE Solutions LLC;  ESD (electrostatic discharge) Task Group, led by Chairperson Bob Vermillion, RMV Technology Group LLC; and the Education Committee, led by Chairperson Jennifer Neid of T.O. Plastics Inc.

Neid and Jennifer Blocher of Sealed Air will present a two-part “Voice of the Customer” AORN survey during Healthpack.

Ideas for new task groups are welcome, too. Bring them to the IoPP MDPTC meeting at HealthPack, or e-mail Karen Greene.

Hope to see you there!

Daphne Allen

Posted in Medical Devices, Sustainability | No Comments »

Security For Medical Device Packaging

Oliver-Tolas Healthcare Packaging  (Grand Rapids, MI) has launched a range of technologies for brand identity reinforcement and protection from counterfeiting.  The technologies can be used for overt visual assurance of a package’s authenticity and in a multi-layered approach using a Micro Text solution that Oliver-Tolas has also announced.

“Medical device counterfeiting is a growing concern, highlighted be recent incidents of diverted shipments and counterfeit devices coming onto the market,” says Dr. Jane Severin, director of technology, Oliver-Tolas.

“Counterfeiters are very bright and have done amazing things in duplication. The coding technologies we are offering would be very difficult to duplicate–the cost and time involved would be prohibitive,” Severin adds.

WaterMark and LogoTint technologies imprint logos, messages, or graphics on pre-made pouches and thermoform-fill-seal roll stock. WaterMark can also be used for marking die cut lidding.  Substrates include medical grades of coated Tyvek and coated paper.

WaterMark markings are flexo or gravure printed on substrates coated with  Oliver-Tolas’  SealScience water-based adhesives.  LogoTint imprinting via flexo prints on specially modified Oliver-Tolas Xhale hot-melt adhesives.  With LogoTint, the adhesives are tinted to provide color intensity.

In the Xhale adhesive technology, solids are applied to the substrate in a uniform dot pattern. The dots merge during sealing producing a caulked effect. The effect increases the intensity of the color in the seal area providing for strong seal evidence and easier seal inspection.

Discoverable only with the aid of a microscope, Micro Text appears as a printed line to the naked eye. Deliberate random errors can be used to make the text marking harder for a counterfeiter to copy. The semi-covert text can be printed on the LogoTint adhesive and on other substrates including films, foils, and coated medical grade papers, Severin says.

In another solution with implications for security assurance, Oliver-Tolas has launched VisiSeal. A new proprietary SealScience water-based adhesive for coating LDPE, foil, and other substrates, VisiSeal is formulated to undergo a color change upon sealing. The resulting seal enables users to determine the seal’s integrity visually without opening the pouch.

“We are very excited about this technology, which we see as a multi-layered solution for our customers. End-users can benefit from the ability to do a quick visual inspection for seal integrity,”  says Severin.

“VisiSeal completely changes color with the heat of the sealing process. The  seal offers a higher contrast for detecting channels and voids in the seal area.

“(Also) at some level VisiSeal promotes security in that it is very difficult to duplicate the look of the seal, and the pouch cannot be opened and resealed without showing evidence of tampering,”  Severin adds.

Dave Vaczek

Posted in security | No Comments »