Life Science Leader: A Guide to Pharmaceutical Serialization

In the August 2010 issue of Life Science Leader, Gunter Schilpp, Marketing Manager for Mettler Toledo writes a very interesting primer on the application of serialization within the pharmaceutical market.

This piece gives some interesting highlights on the basics of serialization, the minimum implementation requirements, equipment, complexity and regulatory uncertainty involved in pursuing this process.

Mr. Schilpp does an excellent job explaining the various issues and positives of this important evolution of the track and trace solution of supply chain security.

Mr. Schilpp conclusions are that pharmaceutical supply chain serialization should be “considered as an overall strategy of supply chain safety, security, and efficiency.”

Secure Pharma Chain certainly agrees that serialization will become an important component of an overall strategy of supply chain safety but does not believe that there is any one solution or technology that will simply solve supply chain safety and security.

Secure Pharm Chain feels that serialization will be an important tool as part of a larger tool set of solutions that the supply chain uses in defending their inventories and protecting consumers from those intent on tainting the market with fraudulent, adulterated, substandard or counterfeit medications.

Secure Pharma Chain endorses a strategy which incorporates the inclusion of a variety of tools, solutions and technologies, with material authentication as a centerpiece, as the most comprehensive, cost effective and efficient way for the global pharmaceutical supply chain to manage risk and protect both their brand and consumer.

There is no one technology that will solve this problem of supply chain safety and security.

Serialization, like other Track and Trace solutions, follow the transaction from point to point and are important piece of the puzzle, but they require a sophisticated and expensive process that all members of the supply chain must comply with or the chain is broken. Ultimately it does not tell the person handling that product that what is inside the box is authentic and safe.

Authentication, with its ability to verify and authenticate the product and its components at any point in the chain, allows each member of the supply chain the vital assurance of the safety and efficacy of a product from manufacturer to the point of dispense.

Coupled together both tools can protect consumers from those intent on making a profit at the expense of their health.

Knowing where the box has been is important but verifying what is inside the box is vital.

To read the Life Science Leader article, visit:
http://www.lifescienceleader.com/index.php?option=com_jambozine&layout=article&view=page&aid=4091&Itemid=56

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

Fake Drugs are a Real Menace

Quality and safety concerns hurt India’s pharmaceutical promise. A new report studies the extent of such worries.

Nick Schulz, Editor of American.com and a fellow at the American Enterprise Institute writes an interesting piece which was posted June 3rd on Livemint.com regarding the Indian Pharmaceutical industry and its largest obstacle in its rise to become a true pharmaceutical power-“concern over the quality and safety of its pharmaceutical supply chain.”

Mr. Schulz states, “if India can overcome these concerns—something a report published on 18 May indicates is possible—the sky is the limit for Indian firms to push the technological frontier in this critical industry.”

Some of the highlights from Mr. Schulz:

· Concerns about fake and substandard drugs have led to multiple actions by governments around the world to hinder trade in Indian medicines. In 2008, the European Union detained Indian drugs citing concerns over counterfeiting and fakes. Governments from Sri Lanka to Nigeria have also blocked some Indian drugs from entering the market. Drug industry officials from Japan to the US have also fingered fakes as a chief obstacle to a more robust Indian drug industry.

· The Indian government has pushed back against this common perception, releasing a report late last year claiming that the vast majority of drugs produced in India were of high quality. But that government-sponsored report was likely far too optimistic. Its underlying data and methodology have not been made available to the public, and its findings flew in the face of anecdotal and other evidence that India’s problem with quality is genuine.

The article also reports on a recent study co-sponsored by the London-based Legatum Institute and the New Delhi-based Liberty Institute, A Safe Medicines Chest for the World: Preventing Substandard Products from Tainting India’s Pharmaceuticals.

· In Delhi, 80% of the sampled pharmacies were providing at least some substandard medicines (ranging from drugs with zero-active ingredient to those with chalk or talcum powder substituting for active ingredient). In Chennai, almost 40% of the surveyed pharmacies were found to have sold some below-standard products.

· Meanwhile, 7% of the samples from wholesale traders that the researchers investigated were found to be of poor quality. This is encouraging, in that it is a small enough percentage that one can imagine a concerted effort tackling this problem. But since wholesalers sell across the market, it means just a few bad actors can have widespread impact.

· Almost three quarters of the pharmacists surveyed admitted there was a problem with substandard medicines and said they knew of pharmacists who were complicit in the sale of substandard drugs. Perhaps most worrisome, over 90% of respondents said they had been approached by a wholesale trader offering to sell them substandard pharmaceuticals at a discount. Most of the pharmacists claimed that government corruption and bribery were problems in maintaining high standards. And almost 25% of the pharmacists reported that government officials had demanded bribes of them.

Mr. Schulz explores some of the necessary measures that the Indian Government and the Indian Pharmaceutical Industry need to do to improve their quality, protect the pharmaceutical supply chain, improve their commercial reputation and protect consumer’s world wide.

Secure Pharma Chain Blog encourages all members of the pharmaceutical supply chain world wide to protect themselves from fraudulent, adulterated and counterfeit medications by deploying solutions that authenticate and verify the inventories.

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

To view the report on livemint.com, visit: http://www.livemint.com/2010/06/03210904/Fake-drugs-are-a-real-menace.html.

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/.

Are Counterfeit Medicines on the Rise?

The prevalence of counterfeit medicines has often been thought as rare in developed countries. This view is changing and changing fast as seizures of counterfeits are on the rise overseas and here in the United States, but perhaps most alarming is the rate of which they are increasing as portrayed in a recent article in Bloomberg News.

According to Pharmaceutical Security Institute, an organization of 26 drug makers, seizures of counterfeits jumped 24 percent in 2007, which amounted to 403 different fake medications confiscated in 99 countries in 1,513 incidents.

Troubling is the fact that copies of 19 of the world’s 25 best-selling medications are among those seized by industry security, customs agents and police last year, according to data compiled by Bloomberg News.

These trends emphasize a need to strengthen our security measures here in the U.S. against an emerging sophisticated criminal element, which seeks to profit at the expense of our health.

We must take a proactive approach to secure our supply chain and most importantly protect our consumers!