Turkish Serialization Plan Delayed Yet Again

In a SecuringPharma.com online article written by Phil Taylor and Keribar Duman they document yet another delay in Turkey’s efforts to adopt a nationwide serialization coding system for pharmaceutical products.

According to the article, the further delay is a result of pharmacies still not having implemented the necessary technology for the process to begin.

Turkish authorities have pushed for the serialization due to widespread fraud in the reimbursement of medications, which is thought to cost the government over $150 million a year and as a deterrent to counterfeit and illegal drugs.

This is the third official delay of the ITS (Ilac Takip Sistemi) system. It was first set to launch on January 1, 2009, then July 1, 2009 and now the latest implementation date was at the start of 2010.

The ITS system was to employ a 2D datamatrix coding to medications that are either produced or imported into Turkey. According to the article the lack of implementation is the “ability and willingness in some cases-of pharmacies to implement and use the system for reading the codes”.

The Turkish Pharmacists Association has been instrumental in pushing authorities for extensions for the regulatory mandate and are on record as saying that issues with the ITS system make the process unworkable.

The inability of Turkey to implement this process in a timely and efficient manner exemplify the issue of a regulatory authority mandating a single approach to fraud, adulteration and counterfeit within a pharmaceutical supply chain. A serialized approach is totally dependent upon an entire system and process adopting an end to end “daisy chain” which is expensive and cumbersome to implement and maintain and relies on total compliance to become effective. Without 100% cooperation the process loses nearly its entire effectiveness and value.

Secure Pharma Chain Blog and XStream Systems; endorse a layered approach of material authentication, pedigree, overt and covert marker technology and ultimately serialization as the most effective way to efficiently, economically and effectively protect an entire supply chain. A multiple technology solution does not require absolute compliance to make it effective and valuable. In a layered technology approach, each solution provides specific protection which overlaps without creating added costs or onerous mandates.

To read Taylor and Duman’s article, visit: http://www.securingpharma.com/40/articles/366.php.

To learn more about efficient pharmaceutical supply chain technologies, visit: http://www.xstreamsystems.net/.

Turkish Government to Delay Implementation of Barcode System to Stamp Out counterfeit Drugs

Initiative officially delayed until October, but industry experts anticipate the process to be pushed back further.

The Turkish newspaper, Today’s Zaman recently published a story about the implementation of a drug tracking barcode system in place to combat counterfeit drug in Turkey. However since the publication of the article, pressure from pharmacies has delayed the implementation from July to October. Most industry experts expect the delays to go beyond the October schedule because of the significant costs to small dispensing pharmacies.

According to the article:

• Turkey is identified as being one of the largest global purveyors of counterfeit drugs.


• The ambitious tracking system, which industry insiders estimate has already cost more than $200 million this year alone in the run-up to its implementation, has been fraught with difficulties.


• Dr. Roger Bate in last week's Journal of the American Enterprise Institute, his limited study of a small sample of drugs in the US purchased over the Internet revealed that Turkey is the largest single supplier of drugs bought online in the US. He documented a number of raids in Turkey that revealed all aspects of the counterfeit drug trade -- importers and local manufacturers of counterfeit products, wholesale distributors repackaging fake and old medicines that should have been destroyed and printers making packaging for the manufacturers. “The products I have seen,” he told Today's Zaman, “were manufactured by large Western companies in Turkey for the Turkish market which were diverted -- possibly illegally -- to the US by Internet sellers.”


• The implementation of this system is also meant to act as a prevention of fraud against the medical insurance system, which is being defrauded by unscrupulous doctors and pharmacists hungry to take advantage of the easily cheated system.


• Pharmaceutical companies -- the ones whose pocket books are arguably most affected by the proliferation of counterfeit drugs in Turkey -- have been amongst those who were resisting the implementation of the barcode system.

Most have said that this program which is slated to use a GS1-compliant 2D barcode will cost the country over $150m per year. The delay in this program is seen as a major setback to companies who tout track and trace technologies as the answer to counterfeit and adulterated medications.

XStream endorses all solutions to the issue of counterfeit, adulterated and diverted medications and believes that a comprehensive suite of technologies are necessary to adequately protect the global pharmaceutical supply chain. XStream believes that autentication and verification of the contents of the unit of sale, which is available via its XT250, is a critically important componant to securing medications from production to dispensing.

To read the entire article, access the link below:
http://www.todayszaman.com/tz-web/news-184271-105-barcode-system-to-stamp-out-counterfeit-drugs.html

To learn more about the XT250 visit us at:

http://www.xstreamsystems.net/

What the True Pharmaceutical Security Focus Should Be: Authentication

As many of those who have spent many years within the Pharmaceutical Supply Chain, I watch the major players within the pharmaceutical industry jockey and debate the current initiatives that are intended to secure the safety and efficacy of the medications that we in the United States take daily.

In this era of globalization we in the United States find ourselves increasingly consuming medications that use foreign produced raw materials, outsourced manufacturing and are packaged overseas. Although most of these efforts are managed and regulated according to tight corporate and FDA scrutiny, serious issues have arisen recently which demonstrate nefarious intent to circumvent the safety and security of these globally produced products.

Additionally we find international and domestic criminal organizations, realizing the potential of high profits and low risk, using sophisticated operations to adulteration, dilute or counterfeit medications that make their way into our drug stores and healthcare providers.

The threats to our safety as a nation are real. The danger that contaminated, adulterated, diluted or counterfeit medications that our population currently faces is increasing every day.

Unfortunately we find that there are few deterrents or regulatory processes in place to adequately protect our population from these sophisticated threats to our collective health.

Currently the Congress, Federal and State regulatory agencies are grappling with the most effective way to deal with this clear and present danger. To date most if not all of their efforts have been focused on track and trace technologies and protocols. Track and trace encompass RFID, advance bar codes; hologram labels technology and pedigree protocols.

Although these efforts are part of the solution, they fall short of truly and efficiently solving the problem. The obstacles to quickly adapting them as an effective solution are many. They are costly, time consuming to adopt, have numerous technical challenges, are not standardized and most importantly require each member of the supply chain to be synchronized and monitored for them to be an effective deterrent.

However the biggest drawback is that the only thing that track and trace technologies and protocols adequately track and trace is the packaging that the medication is packaged. Despite all of the cost, technical challenges and time consuming efforts that they entail, these efforts do not authenticate or verify the actual contents which may have been adulterated, counterfeited, diluted or contaminated at one of various points within the supply chain.

Currently XStream Systems, XT250 technology has the ability to quickly, efficiently and effectively authenticate and verify the contents of the medication within the sealed container. This process can happen in a very cost effective manner anywhere within the Pharmaceutical Supply Chain with little or no change in processes or protocols. It can complement existing Track and Trace initiatives by actually providing authentication documentation or operate as a standalone system.

The cost of implementing and operating authentication technology such as the XT250 is a fraction of the initial start up costs of an RFID system and it could be operational in a fraction of the time that it would take for one segment of the Pharmaceutical Supply Chain to implement universally.

Maybe it is just too obvious but I hope that those in a position to make a difference take time to look at filling in the gaps in the current mindset and direction of protecting our Pharmaceutical Supply Chain. Hopefully they discover that the ultimate solution is to authenticate and verify what is in the bottle.

Alan Clock, Senior Vice President, Sales and Marketing, XStream Systems, Inc.

Human Error Eliminated?

Pharmaceutical authentication is ever evolving to meet users’ needs and at the top of their wish list is the desire to eliminate as much human entry errors as possible. This is why the new scanning feature on the XT250 System is so exciting.

Using the product barcode already on the pharmaceutical in question, an operator scans the container; thereby, automatically selecting the drug name, manufacturer, NDC code, dosage, and quantity. The XT250 will use this information to locate the medicine’s signature standard and compare along side the sample. The results will display as “passed” or “failed”.

Simple authentication with this new feature enables the entire process to run smoother, quicker and more efficiently by eliminating entry error.