Friday, March 28, 2008

Heparin Contamination and Recalls

We at XStream Systems have been monitoring the Heparin contamination and recall situation very closely. Each day we are uncovering more stories on the who, what, when, where, and why.

Aside from the precautionary recalls of the product from the market, and the normal spin on the topic by the media, there really is a problem with a number of the lots of medication.

Adding to recent stories on other contaminated products, China is again accused in this case. Here is a link to a summary of the heparin situation so far. This article points out that China is waking up to the issue.

Sadly, the number of U.S. deaths is up to 19.

Saturday, March 22, 2008

Counterfeit Pharmaceutical Statistics

No one has exact statistics as it relates to the entire scope of the issue of counterfeit pharmaceuticals and its impact on the global pharmaceutical supply chain.

The only consistent to these varied estimates, is that the numbers are all staggering and on the rise. The following were recently presented in a presentation at a global security forum and are attributed to WHO (World Health Organization).

Realize that these statistics do not include the issues of raw material and production errors that most recently surfaced with the example Baxter's Heparin product which was produced with contaminated raw materials..
  • 10% of all pharmaceuticals in the global supply chain are counterfeit.
  • In some developing countries the percentage of counterfeit pharmaceuticals in their supply chain is as high as 70%.
  • Sales of counterfeit pharmaceuticals in the United States were estimated in 2006 to be at least $32B.
  • Developing countries of the Western Pacific (China, Philippines and Vietnam) comprised the region with the most reported cases of counterfeit pharmaceuticals with nearly 49%.

Segmenting counterfeit drugs globally:

  • 16% of all counterfeit drugs contain the wrong ingredients.
  • 17% of all counterfeit drugs contain incorrect amounts of the proper ingredients
  • 60% of all counterfeit drugs have no active ingredients at all.

Although there is no exact number to these statistics nearly every expert agrees that this issue will proliferate and become a significant global health issue in the next several years.

Public health and patient safety within all levels of healthcare rely on a safe and secure pharmaceutical supply. Unless this scourge is controlled many thousands will die because government entities and private industry are not taking the necessary efforts to secure their manufacturing and supply chains.

XStream Systems feels that its XT250 system, which utilizes EDXRD and can authenticate and verify the contents of sealed containers will be one of the most important technologies used in battling this global menace.

Tuesday, March 18, 2008

Opinion: Patient Safety Starts in the Supply Chain

Patient Safety continues to be a priority among nearly all healthcare providers within the United States. These providers are spending literally hundreds of millions annually to upgrade software, hardware, procedures and processes to control patient safety issues that effect millions of patients every year.

We know on the pharmaceutical front, hospitals, pharmacies and physicians are being pressed by regulatory agencies, managed care organizations and patient safety advocates to reduce the number of adverse incidents within their control.

As these healthcare providers increase their ability to control adverse incidents, a potentially more ominous and significantly more dangerous, seemingly undetectable threat is proliferating within their midst and they have few tools to adequately combat the threat.

As we are seeing on a daily basis in the news, there is a new and dangerous threat that confronts these healthcare professional on a daily basis, the very real and expanding menace of contaminated, adulterated and counterfeit medications.

In a new economy of a global supply chain of pharmaceuticals, healthcare providers in the United States are now facing a hazard that their peers globally have faced for many years, medications that at best may not be clinically efficacious and worst may be a serious risk to their health.

The statistics and economics of this scourge are well documented but what is not as apparent, especially to those healthcare professionals on the front lines, is what and how they can protect their patients from this peril.

The solution for this danger, lies within the Pharmaceutical Supply Chain.

This solution goes beyond the current efforts of pedigrees, RFID chips and barcodes.

The solution is the verification and authentication of the contents of the medications, within their sealed container within the various stages of the pharmaceutical supply chain from manufacturer to distributor to dispenser.

This solution can only be found in the technology of EDXRD and the overall solution of XStream Systems XT250.

By using EDXRD, the XT250 penetrates through the packaging of the material and authenticates the molecular signature of the material within the container eliminating the danger of contaminated, adulterated and counterfeit medications reaching the patient or end consumer.

The XT250 is engineered to be used within the Supply Chain, by non-technical resources in a fast and efficient manner by the manufacturer, distributors and dispensers to protect the effectiveness of the medications being administered by healthcare professionals.

Healthcare professionals need to question their pharmaceutical supply chain partners and ask them what defenses they have deployed within their business to protect your patients from this ever growing threat.

Healthcare professionals need to understand what kind of analysis if any is being done to insure that the medications that they are dispensing or administering to their patients are safe and effective.

Healthcare professionals need to take an active role in making certain that the supply chain which services them has the XT250 deployed so that their patients are protected from the global scourge of contaminated, adulterated and counterfeit medications.

Friday, March 14, 2008

Completion of FSP training

A five day training seminar for new Field Service Providers (FSPs) was held the week of 3/03/08 at the XStream Systems Sebastian plant. Attendees included x-ray service technicians from Remetronix, Eastern Applied Research and Compass Engineering.

The class time was split between classroom theory and hands-on sessions from unpacking the unit at a customer site, to assembling components and performing an initial test, to readying the system for the Alignment, Calibration and Tool matching Process (ACT Process).

All participants will receive a factory certification authorizing them to install the XT250 System.

Although the ACT Process had been explained during classroom theory, this certification will be issued by an XStream Systems scientist during a field installation. XStream will now have service coverage throughout the US, Canada and the UK.

Thursday, March 13, 2008

Outsourcing: The Whole is Only as Good as the Sum of Its Parts!

One of the little known facts about the pharmaceutical industry is how much of its manufacturing is outsourced. Over 80% of the pharmaceutical ingredients used in the manufacture of US drugs are outsourced to foreign countries, with a majority of these ingredients coming from China and India.

Understandably, with the current news on the contamination of heparin in the US supply and the role the Chinese supplier played in this case being questioned, quality control has become a major concern. Since the whole is only as good as the sum of the individual pieces, should we not be questioning the quality and safety of all outsourced materials?

Timely testing of these ingredients should greatly reduce quality issues, adverse reactions and recalls. After all, diligence in safety of what goes in to our bodies cannot be overstated!

Supply Chain Solutions

Competitive Advantage When Addressing Sensitive Issues:

Protect Corporate Brand / Reputation –
• Limit Litigation, Document Authentication of Inventory and Protect BrandImage

Returns/Recalls –
• Validating the Returned Products

Regulatory Oversight & Compliance Issues, State by State “Pedigree” Compliance, RFID and Associated Costs –
• Setting the Industry Standard & Address Regulatory Issues

Counterfeits –
• Maintain Inventory Integrity

Increasing Revenues –
•Competitive Advantage in Margin Thin Market - Global Sourcing and Third Party Authentication

Tuesday, March 11, 2008

Tip of the Iceberg

When giving presentations across the country, there is one slide in particular that seems to stand out and really hit hard on the counterfeit pharma issue and what is really out there. This image contains a quote which says it all. It states, “Most of the counterfeits are detected largely by accident. It means that we are just seeing the tip of the iceberg...We presume there is an iceberg to be found somewhere under the tip, but no one has been able to put their head under the water.” By Valerio Reggi, World Health Organization (WHO) 2007.

Monday, March 10, 2008

Remedy for a Plagued Drug Supply Chain

One of the current issues on everyone’s mind today is the quality and authentication of prescription drugs. With the rising cost of prescriptions, individuals are ordering online, senators are proposing drug importation, and manufacturers are outsourcing their raw materials. All of this has compromised our drug supply.

Counterfeits have plagued the medical community for longer than most people realize. Did you know that the first regulatory action against counterfeit medicines in the U.S. was the Pure Food and Drugs Act of 1906?

It was titled “An Act of preventing the manufacture, sale or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for relating traffic therein, and for other purposes.”

Since then, great strides have been made both by those developing new drugs to save us and by those profiteering pirates who contrive to make copies good enough to visually fool even the most learned man. But now science is causing a glitch in the illicit trade program. A new “scientist-in-a-box” technology which can look at a drug’s molecular level right on the front line has been unveiled!

Think of what this means: bringing real-time analysis to manufacturers, wholesalers, and repackagers. Forewarned is forearmed - and the sooner you can detect a counterfeiter the soon you can put your company and the public out of harm’s way!

Friday, March 7, 2008

Part 4: Who is liable when a counterfeit or adulterated medication gets to the consumer?

Liability Opinion Series (4 of 4)
by Alan Clock, Senior Vice President, Sales and Marketing
XStream Systems, Inc.

Now, with the release of the XT250 System and its use of EDXRD technology, everyone within the pharmaceutical supply chain has a tool that allows them to authenticate, verify and document the actual contents of a sealed container down to its molecular structure.

Additionally XStream Systems has built in a robust networking capability within the XT250 System which allows the user to interface the results of its analysis into the production, inventory, pedigree and a variety of other industry software so that the tested product can be tracked throughout the process. This networking capability will allow the Production or Corporate Security Manager to track and trace the analysis, QA/QC, receiving, returns or pedigree process globally, within a distribution network or within a warehouse.

Maybe now that there is finally a solution to an ever increasing problem of counterfeit and adulterated medications, the manufacturers, distributors and dispensers won’t feel the need to pass on the responsibility, especially since they are ultimately liable and will be able to engage XStream Systems in a proactive solution.

About the author: Alan Clock is an industry veteran and a pharmaceutical supply chain expert with over 20 years experience in senior roles at AmerisourceBergen, McKesson and Cardinal Health.

Thursday, March 6, 2008

Part 3: Who is liable when a counterfeit or adulterated medication gets to the consumer?

Liability Opinion Series (3 of 4)
by Alan Clock, Senior Vice President, Sales and Marketing
XStream Systems, Inc.

While attending the SecurePharma 2008 Conference in Philadelphia, the liability issue was tasked to a legal expert in product liability law. Basically in all of the recent case law he studied and presented, legal precedence dictates that the majority of responsibility falls onto the distributor and dispenser as it relates to counterfeit or adulterated medications that pass through them onto the consumer.

Not to be absolved altogether, the manufacturers are facing a whole new set of liabilities, since over 80% of their raw materials and in many cases a growing portion of their production comes from international sources. These are sources which are coming under intense scrutiny because of their lack of oversight and general quality control.

Going forward, the reality is everyone within the pharmaceutical supply chain is going to bear the responsibility and ultimately the liability for the protection of their portion of the supply chain. Until recently, that seemed like an impossible task given that their only tools were bar codes and pedigrees that in fact were easier to counterfeit or adulterate than the materials within the containers.

In the next and final segment to this series, I'll bring up how XStream and the XT250 System work to the manufacturer's, wholesaler's, distributor's, and dispenser's advantage.

Wednesday, March 5, 2008

Part 2: Who is liable when a counterfeit or adulterated medication gets to the consumer?

Liability Opinion Series (2 of 4)
by Alan Clock, Senior Vice President, Sales and Marketing
XStream Systems, Inc.

(continued from yesterday)...
If you talk to a wholesaler or a distributor, they tell us they only buy or source product directly from the manufacturer. When applicable because of a state law, then they receive a pedigree. Many feel this protects their inventories and in turn protects them from liability if a product ultimately is found to be adulterated or counterfeited after it winds its way to the consumer. Usually wholesalers and distributors don’t publicly discuss the huge gap of returns and globally sourced products that leave their inventories wide open to a variety of sources beyond their control.

The dispensers, the final piece of the supply chain, tell us that they buy only from the wholesaler or manufacturer and they have contracts with these entities. To dispensers, this means the products from their sources are safe, secure and can be given to patients without worry. It would be naive for anyone that has experience in this industry to think that by the time product is received at the store level, that it is still pristine; especially given the probability that the product could have been touched by nearly a dozen different delivery agents, distributors, couriers or pharmacies by the time it gets to the dispensing location from the manufacturer.

Maybe it’s not so much of a game of “hot potato” but a case of “hear no evil, see no evil, speak no evil”. Meaning that until critical members of the pharmaceutical supply chain have an effective solution or set of tools beyond RFID, bar codes and pedigree to combat issues proactively, they feel like they have to pass the buck or ignore the problem.

Tomorrow I'll address the discussion on pharmaceutical liability at the "SecurePharma 2008" show I attended last week...

Tuesday, March 4, 2008

Who is liable when a counterfeit or adulterated medication gets to the consumer?

Liability Opinion Series (1 of 4)
by Alan Clock, Senior Vice President, Sales and Marketing
XStream Systems, Inc.

As XStream Systems navigates throughout the Pharmaceutical Supply Chain to sell our revolutionary materials analysis solution to manufacturers, wholesalers, distributors and dispensers, we continually find ourselves challenged by whomever we are speaking with. From Senior Executives to Operational Managers, the responsibility and liability for security and safety of the pharmaceuticals that they are manufacturing, distributing or dispensing always seems to be in question.

It really appears many within the pharmaceutical supply chain seem to be playing a game of “hot potato”, at least as it relates a proactive solution. Who owns the responsibility for a pharmaceutical product that is counterfeit or adulterated that makes its way to a consumer?

If you talk to a manufacturer, they absolve themselves of responsibility because from their perspective, the product that left their distribution point was shipped out pure and unadulterated. Never mind that it is THEIR brand, with whom they have likely invested billions, that takes the hit publicly because someone has tampered with the product downstream. We know that it took Tylenol many years to recover from its tampered product and cost McNeil many millions of dollars.

Tomorrow, I'll discuss the wholesaler's and distributor's point of view.