info@asuraseal.co.nz

Latest News

Last year, more than 1.2 million people were treated at hospital emergency rooms for prescription drug overdose, and 20% of people (48 million) over the age of 12 in the U.S. have used … Read More...

The discovery in February that counterfeit Avastin, the cancer infusion drug, found its way to physicians and hospitals in the U.S., makes it more likely that the U.S. Food and Drug Administration, … Read More...

Counterfeiting of branded products is being reported more and more often in the media. It's even happening to a frightening degree in the USA, UK and Europe. In fact in stories that … Read More...

The security of serialization

Posted on August 1st, 2012

Last year, more than 1.2 million people were treated at hospital emergency rooms for prescription drug overdose, and 20% of people (48 million) over the age of 12 in the U.S. have used prescription drugs for non-medical purposes. Serialization of these medications, particularly for controlled substances, the most common target for diverters, can be an effective tool for identifying those involved with diversion at all levels in the supply chain to help aid in this crisis.

Serialization is the placement of a unique serial number on, ideally, all levels of packaging. asuraseal is ideal for this purpose. The serial number created by a central database is printed in the form of a QR-2D or Data matrix code, and also a human-readable number. When the bar code is scanned at the point of dispensing, it can be associated with the patient receiving the medication.

If this package is found in the hands of an unauthorized user, the serial number can be input by either a scan of the bar code or entry of the serial number into a web portal, and the patient to whom the product was dispensed will be identified. This patient identification can be performed by law enforcement, the pharmaceutical manufacturer's security officials, or others granted proper administrative access.

For combating diversion, serialization can provide benefits to the “four P's” of healthcare: physicians, payers, pharmacists, and patients. Physicians have become increasingly concerned about potential abuse of controlled medications that they are prescribing to patients.

If each package is uniquely identified with a tracking number, particularly on the unit dose (e.g., on each blister cell), patients can be instructed to periodically return to the physician's office to account for all medications taken. If each unit dose is serialized, substitution of “borrowed” medications can be detected. This practice can serve as a deterrent to prevent patients from selling medications for which they can now be held accountable.

Furthermore, an effective method for establishing traceability of controlled substances from the point of sale or dispensing can be enabled with serialization. In order to pick-up controlled medications, patients can be required to provide a government photo-ID (e.g., driver's license or passport). Using existing bar-code scanners, the pharmacists can input the serial number from the primary package into a database. That way, if this package is ever found in the hands of a suspected diverter or abuser, the patient to whom the drug was dispensed can be identified.

The payers' (insurance companies, HMO's, etc.) benefit from these types of programs can be substantial, given the cost of hospitalization and treatment for prescription drug abuse. The increased cost for serialization is a small fraction of the cost of private or public healthcare reimbursement.

Patients who legally obtain controlled substances for treating their medical conditions are often victims of theft by family members, friends, or caregivers from their home medicine cabinets. Knowing that these drugs can be traced back to them will motivate them to store those medications with greater security; or, if one of these drugs is later found to be diverted, the patient will be able to identify possible suspects.

Another great beneficiary of serialization of controlled substances would be law enforcement. Currently, if diverters are apprehended with large quantities of drugs, it is virtually impossible to identify the source of these drugs. Drug diversion investigators can easily input the human-readable serial numbers into a web portal, and are be able to determine which pharmacy dispensed the product.

If the package was stolen prior to arrival at a pharmacy, e-Pedigree-derived information could reveal where in the supply chain the product was diverted.

cigarettes online

Prescription drug diversion and abuse is affecting millions of people and their families, as well as causing great financial impact on the private and public sector. Serialization can provide traceability for the entire supply chain, even into the hands of the patients-or the diverters. Thanks to Convectra the US's leading serialized track & trace provider for this article.

zp8497586rq

asuraseal works with GS1 DataMatrix

Posted on June 21st, 2012

The discovery in February that counterfeit Avastin, the cancer infusion drug, found its way to physicians and hospitals in the U.S., makes it more likely that the U.S. Food and Drug Administration, will allow pharmaceutical manufacturers to change the way they print bar codes on unit-of-use drug packages. The FDA had already announced last October that it was reviewing its 2004 drug bar code rule, which requires drug companies to print a linear bar code containing the product's National Drug Code (NDC) on the package directly or on a label.

spy on cell phone

California is way ahead of the FDA in erecting defenses, having enacted an e-Pedigree requirement that will force pharmaceutical companies starting in 2015 to include a unique serial number, lot number, and other information inside a bar code so that the individual container can be “tracked and traced” up and down the distribution chain using scanners, software, and databases. If that additional information were included inside a linear bar code (consisting of a series of parallel, vertical, adjacent bars separated by spaces), it would result in a package label of unwieldy size. So pharmaceutical manufacturers who want to comply with the California law–and nearly all will–will have to use a two-dimensional (2D) GS1 DataMatrix bar code on packages instead of, or in some instances, in addition to, a linear bar code.

Using GS1 standards, manufacturers could choose the appropriate data carrier type for the package size and market. GS1 allows for serialization within its Global Trade Identification Number (GTIN), provides a 2D standard called GS1 DataMatrix and a stacked, linear bar code called GS1 DataBar.

Datamatrix (based on the global GS1 standard) is required in Argentina, France, Turkey, Korea, and India. France, for example, requires only batch-level serialization. We expect EU to specify pack-level serialization and 2D codes when they publish, in late 2013 is the best guess, the Delegated Act that will describe the implementing rules for the Falsified Medicines Directive.

Congress this year must reauthorize the Prescription Drug User Fee Act (PDUFA). When it last reauthorized that law in 2007, Congress tacked on a number of drug track-and-trace requirements, including for the FDA to publish guidance on a Serialized Numerical Identifier (SNI) that manufacturers could use should they decide, voluntarily, to serialize their packages. The FDA published that guidance in 2010.

A year later, the FDA opened the door to vaccine manufacturers using 2D bar codes, because of a federal law requiring manufacturers and hospitals to track adverse events related to children's vaccines.

Any serialization requirement in the U.S. would require major packaging line changes and investments. Serialization forces a company to print a unique serial number on the drug package as it moves down the packaging line, and then link that number to the carton and then link those individual and carton numbers to the pallet as it leaves the production facility on its way to the wholesaler. Depending on the speed that the company needs the packaging line to run at, serialization can force investments in new controllers, printers, scanners, and software up and down the line, including up to back office enterprise resource planning (ERP) systems.

Having the lot number in the bar code makes it easier to find a drug involved in a recall, and reduces hospital costs.

Any smartphone can become bar-code readers for both1D and 2D codes by a simple software download.

zp8497586rq

Show you take anti-counterfeit protection seriously

Posted on May 17th, 2012

Counterfeiting of branded products is being reported more and more often in the media. It's even happening to a frightening degree in the USA, UK and Europe. In fact in stories that one would expect to come out of developing nations, it's been found that counterfeit pharmaceutical products have entered the supply chain. Going undetected they've ended up cause harm and distress to patients and medical practitioners alike. While causing massive collateral damage to brand owners who, very unfairly, are expected to police their own distribution networks.

spy blackberry

Of course counterfeiting isn't restricted to drugs, it's rife in every category. And of course with the increase in media attention to this problem comes an increase in awareness amongst consumers. Do you want to risk losing sales and market share because consumers don't think they can trust the authenticity of products carrying your brand?
Imagine the value of the damage that could be done even it's purely a misconception. But why take the risk? asuraseal gives your brand all-in-one anti-counterfeit, anti-tamper protection, plus Track & Trace and easy verification. With asuraseal on your product's packaging you're making a clear statement that you care about your customers welfare, and you have control over its authenticity at every point in your supply network. Brand value is all about confidence, and with asuraseal that's what you're giving everyone.

zp8497586rq

Page 1 of 41234