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Donfucius Says: July 23rd, 2014. Random Bits Of Wisdom.

  1. “As a child my family’s menu consisted of two choices: take it or leave it!” — Buddy Hackett
  2. “Nature gave men two ends – one to sit on and one to think with. Ever since then man’s success or failure has been dependent on the one he used most.”Donfucius
  3. Preach the Gospel at all times, and when necessary use words.” — Aaron Rogers Quoting Francis of Assisi
  4. “Diplomacy is the art of saying “Nice doggie” until you find a rock.” — Will Rogers
  5. “Before they invented drawing boards, what did they go back to?” –Patti Molloy
  6. “The way we’re going… if I called up another pitcher, he’d just hang up the phone on me.” — Any Brewers Manager
  7. “When someone is impatient and says I haven’t got all day,” I always wonder, “How can that be? How can you not have all day?” — George Carlin
  8. “We’re fools whether we dance or not, so we might as well dance.” — Old & Wise Japanese Proverb
  9. “Blessed are the cracked – for they are the ones who let in the light.” — Donfucius
  10. “Good judgment comes from experience, and a lot of that comes from bad judgment.” — Will Rogers
  11. “I don’t mind how much my Ministers talk, so long as they do what I say.” — Margaret Thatcher

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Posts Tagged ‘2D Barcodes’



Drug Packaging Serialization.

July 14th, 2010

New FDA final guidance jump-starts track and trace.

This article courtesy of Stephen Barlas and Contract Pharma Magazine

serialization binary codes

The FDA’s publication of the final guidance on a standard numerical identifier (SNI) for pharmaceutical packages at the end of March awoke the drug industry from its track and trace slumber. Manufacturers, distributors, pharmacies and their vendors had been snoozing since September 2008, when California pushed back its e-Pedigree implementation date, an action with significant national implications. Instead of having to put unique serial numbers on packages starting January 1, 2011, California, responding to pleas from an ill-prepared drug industry, pushed back that e-Pedigree deadline to January 1, 2015. One-half of all drug packages arriving in the state on that date will have to have unique serial numbers printed on them. The other half will have to follow suit one year later.

“Everybody took a deep breath when the California Board of Pharmacy delayed its e-Pedigree requirement,” agreed Ruby Raley, director, healthcare solutions, Axway, a company that provides the software to run the data repositories that hold information about drug package pedigrees as an individual package moves from the manufacturer to (perhaps) a repackager to a wholesaler and on to the retail or hospital pharmacy. Axway is involved in numerous track and trace pilots with a number of major pharma companies. “Nothing happened last year,” she remarked.

Now, publication of an FDA-approved package serialization scheme has given the pharmaceutical industry a reason to restart its version of California Here I Come. Whereas the California Board of Pharmacy provided no specifics on package serialization, the FDA has; manufacturers no longer have to wait and guess what might be acceptable in the Golden State come January 1, 2015, a date that, given the complexities of e-Pedigree compliance, isn’t so far away.

James McCrory, vice president, products and technology at rfXcel Corp., said, “The SNI guidance is a big deal in three ways. It reflects new interest in federal government safety of prescription drugs, provides endorsement of GS1, which is pretty big since people have been hanging back waiting to see what happens, and matches what leaders and distributors and manufacturers are doing in their own pilots.” The SNI essentially endorses the serialization standard adopted by the international standards group GS1. GS1 has one serialization standard for numbers printed in 2D barcodes (GT10) and a second one for numbers printed on radio frequency identification (RFID) tags (G10).

An agreed-upon format for an item-level SNI is only the first step in a closed-loop e-Pedigree (often used synonymously with track and trace) system such as the one adopted by California, and likely to be endorsed by Congress. Other follow-on elements include:

Security framework for data exchange,

Record retention policies,

SNIs at the pallet and case level,

Standardized chain-of-custody data to be tracked by logistical units,

Standardized electronic data exchange format,

Data carriers with specific encoding formats identified,

Guidelines for reporting exceptions noted by supply chain participants, and

Hierarchy of the SNIs expected in a shipment.

The FDA SNI provides a first-step level of certainty to manufacturers, in terms of compliance with federal expectations, and assures them that the U.S. is moving in the same basic direction as other countries, many of whom are far more advanced in their national track and trace requirements. That is all true despite the limitations of the FDA guidance: it is a suggested package identification formula. There is no federal requirement that drug manufacturers follow it, much less put a serial number on each item-level package.

The limits of the FDA guidance, some of its nuances and its failure to address the important issue of which technology should be used to print the SNI have all combined, apparently, to seal the lips of pharmaceutical manufacturers who just three years ago were touting their track and trace efforts. Prominent proselytizers such as Pfizer, Abbott and Purdue Pharma have declined to comment on the FDA final guidance on an SNI. “I ran this request up the flag pole and have learned that we are unable to grant interviews on this topic,” explained Libby Holman, spokeswoman for Purdue Pharma, which has been an aggressive track and trace experimenter because of its manufacture of OxyContin, a popular target of drug diverters.

Tom McPhillips, vice president, U.S. Trade Group, Pfizer Inc., did not return an e-mail requesting comment. Mr. McPhillips, in his comments to the FDA after the draft guidance was published, asked the agency not to require manufacturers to print the national drug code (NDC) as part of both the machine readable and human readable SNI. The FDA rejected that request.

Nonetheless, manufacturers support the specificity of the SNI, and its agreement with GS1 standards, which gives them more certainty than California’s prescription for a unique serial number. The only guidance in the Golden State law, according to Virginia Herold, executive officer of the California Board of Pharmacy, is that the number be part of an “interoperable” track and trace system. The FDA-recommended SNI is a unique combination of two numbers printed on a package label that identifies the drug inside the package. The FDA final guidance specifies that half of the SNI is the national drug code (NDC), which is essentially unique for each drug made by each manufacturer, coupled with a unique serial number for the second half, generated by the manufacturer or repackager for each individual package. Serial numbers should be numeric or alphanumeric and should have no more than 20 characters. The SNI should be both machine and human readable.

The use of a GS1-compatible SNI means that manufacturers following the FDA guidance are very likely to comply with European, Brazilian, Norwegian and other national requirements for drug package serialization. Meanwhile, other countries are putting track and trace requirements into place, in some instances with more speed than the U.S. Ms. Raley explained that governments footing the bill for public healthcare (e.g. the EU, Brazil, Turkey) are especially concerned about counterfeit product sneaking into the country, since the government does not collect taxes on those transactions. “People are sneaking product in at the border, that is driving government concerns,” she explained.

In the U.S., the FDA has been more concerned about the prospective impact of counterfeit drugs on public health and safety. The 2007 Heparin recall underlined the value of track and trace (had it been deployed by the pharmaceutical chain) with regard to drug recalls. Preventing thefts is an important affiliate benefit, too. In March, thieves broke into an Eli Lilly warehouse in Enfield, CT and stole $75 million worth of prescription drugs. The crooks took pallets of the anti-cancer drugs Gemzar and Alimta, the schizophrenia drug Zyprexa, the antidepressant Cymbalta and other prescription medicines. Theoretically, those stolen drugs could not come back into the legal distribution chain if they had SNIs printed on 2D barcodes or RFID tags on each package’s label.

It is clear that manufacturers are the big winners, relatively speaking, from the final guidance. Scott Melville, senior vice president for government affairs for the Healthcare Distribution Management Association (HDMA), said, “The FDA guidance provides manufacturers and the entire pharmaceutical supply chain with needed clarity.” But while the HDMA has welcomed the guidance, it clearly did not get everything it wanted. For example, the HDMA had not wanted the FDA to endorse an “alphanumeric” as a serial number option.

However, Anita Ducca, senior director, regulatory affairs at HDMA, acknowledged the FDA was responsive to her group’s concerns. “We had a number of things we wanted the FDA to change from its draft guidance and for the most part the agency did that,” she states. “Our members are ready and willing to work within the parameters of the guidance.”

Neither did hospitals and pharmacies get exactly what they wanted. Some pharmacy groups had also pushed for a different SNI. The American Society of Health System Pharmacists (ASHP) had urged the FDA to modify the NDC number so that its components included the RxNorm CUI as the drug/form/ dose component of the code. Justine Coffey, JD, LLM, director, federal regulatory affairs, said, “Currently, ASHP members are struggling with inconsistencies relating to the National Drug Code (NDC) and its application to barcode point-of-care, clinical information systems, and hospital financial systems.”

Axway’s Ms. Raley noted that hospitals are particularly concerned about avoiding medication errors, especially given the passage of the health care reform bill, which mandates a number of new payment methodologies based on the hospital reducing errors of all kinds. She explained that many drugs come in many formulations and doses, information which will not be gleaned from the SNI endorsed by the FDA. Ms. Raley pointed out that hospitals are particularly sensitive to this issue given the publicity generated by the misadministration of Heparin to twins born in November 2007 to the actor Dennis Quaid and his wife.

Minor reservations aside, the HDMA’s Mr. Melville emphasized that the final guidance allows his members and everyone else to move forward. “The first step in an e-Pedigree system is putting a number on the package,” he said. “The second step is what you do with that number.”

For distributors a big issue is how the SNI is printed on the item-level package label. The two options that have emerged over the past half-decade are a 2D barcode or a radio frequency identification (RFID) tag. Distributors have generally favored RFID tagging, since they could check in packages to their warehouses without a reader having to be “in the line of sight” with the individual package. This saves them time, which is important because any e-Pedigree requirement costs the distributor money and earns the company no profit. But RFID tags are expensive, and manufacturers have generally pushed for printing serial numbers within 2D barcodes, not just because the labels are cheaper, but because the packaging lines can run faster than they could if RFID tags are printed on the package. Moreover, RFID tags cannot be used on some products.

The final guidance on the SNI appears, however, to endorse 2D barcode serialization without actually saying so. “The FDA landed on 2D,” stated Ms. Raley. “It is very clear they talked about the total acceptability of 2D although they did not rule out RFID.” RFID does have some significant shortcomings when it comes to package use, such as its deleterious effect on biologics.

Robert Celeste, director, healthcare, GS1 US, said that in fact all the manufacturers who have done pilots, and are doing them now, are putting serial numbers on packages via 2D barcodes. Some are also putting RFID tags on the product label, and on cartons and pallets. He believes it is possible that RFID tags on item-level packages may have utility – if their per unit price comes down – in certain applications, for example, where products must be kept at certain temperatures.

The final guidance, however, is silent on serialization of cartons and pallets, which the California Board of Pharmacy, just to cite one interested party, had pushed for, and on which the FDA had asked for comments.

While the pharmaceutical supply chain now knows that the SNI is the baseline for complying with California’s e-Pedigree requirement, everyone up and down the chain is pushing for federal legislation that would make the California requirement, or some close version of it, national law and might resolve outstanding technology questions as well. The 2007 congressional law that required the FDA to publish some sort of SNI within 30 months – it did not specify guidance versus more legal regulation – also told the FDA to “develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.” The FDA received comments but has done nothing to impose a technology solution, which various players in the drug distribution chain would probably oppose, but which is clearly necessary.

In the 2007-2008 session of Congress, Reps. Steve Buyer (R-IN) and Jim Matheson (D-UT) introduced the Safeguarding America’s Pharmaceuticals Act, which would have established a federal e-Pedigree mandate. That law has not been reintroduced in the current Congress, perhaps, suggested Ms. Herold of California’s Board of Pharmacy, because members of the House and Senate have been overwhelmed with healthcare reform, financial reform and economic recovery. Also, the same sense of urgency that disappeared in California in September 2008 disappeared from Congress at about the same time.

As the HDMA’s Mr. Melville put it, “We want a uniform federal pedigree standard. We can’t have barriers to movement of products.” He added that Reps. Buyer and Matheson, at a hearing on March 10, stated they are working on a redrafted version of their bill. “We are very hopeful it will be reintroduced soon,” said Mr. Melville. “We expect it to look like the California implementation schedule.”

The End

Stephen Barlas is a freelance writer who has written several articles on pharmaceutical packaging for Contract Pharma. He can be reached at sbarlas@verizon.net.

The ATL “Question Man” #2: Security For Hospital Pharmaceuticals.

April 5th, 2009

Question. Do I need to employ security technologies for hospital-bound pharmaceuticals? Who would verify them?
Answer. The answer is must you or should you? Currently there is not a standardization for covert features as they pertain to security packaging.

You must employ security technologies if this is part of your contract with the buyer of your product. You must maintain the pedigree. If you are the brand owner, I feel strongly that you can protect the public by maintaining a record containing information regarding each transaction that results in a change of ownership of a given drug or pharmaceutical ingredient. This includes its sale by the manufacturer, through the wholesalers, distributors, and pharmacies. Overt and covert technologies work in tandem to track and trace and authenticate.

This includes: Lot or batch codes; Integrated Mass Serialization; 2D DataMatrix Codes; Forensic (invisible, non-degradable, nano-molecular) markers; and many other covert techniques.

Many people feel that President Obama will expect manufacturers to take immediate action to protect the drug supply chain, or else face regulation. This prediction comes from two members of the Partnership for Safe Medicine’s board of directors, Marvin D. Shepherd, Ph.D., and Bryan A. Liang, M.D., Ph.D., Partnership for Safe Medicines.

The Partnership for Safe Medicines is a coalition of more than 50 organizations and individuals dedicated to protecting consumers from counterfeit medicines.
“President Obama won’t have the patience that President Bush had waiting for industry,” explains Liang. The onus will be on industry, and the message will be, “If you don’t do it, we will make you do it.”
Shepherd believes that Obama will see to it that FDA mandates both serialization and authentication. “A layered approach will be favored, and companies will get to choose what technologies are employed. But the number of layers to be used may be dictated.”

Photo Below: Be careful when purchasing medications on-line. You may not be getting what you’re paying for.

Notable & Quotable: “Diplomacy is the art of saying “Nice doggie” until you can find a rock.” — Will Rogers

Til Death Do You Part?

March 12th, 2009

We would like to give you a glimpse of the counterfeit drug issues as they exist today. The simple fact is that your life may be at risk, or the life of someone close to you. As you read of the startling facts, please look for the words “ATL Security Note”. At this juncture we will recommend a solution that will inhibit (or eliminate) the counterfeiters ability to provide you (the public) with fake or diluted medicines.

Photo Above: Illicit drugs that were gathered during a law enforcement raid.

Counterfeit Medications – History

First documented cases of counterfeit medicines date back to 4th century BC. For more than 2,000 years, issue of fraudulent production of medicines has mostly been ignored.
Today it is multi-billion-dollar worldwide trade. Fake drugs are estimated to lead directly to the deaths of more than 500,000 people a year across the globe.

WHO (World Health Organization)

Definition of a Counterfeit Medicine

“A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with correct ingredients, wrong ingredients, without active ingredients, with insufficient quantity of active ingredient or with fake packaging.”

Counterfeit Medications

The illicit business is worth $18 billion. It is estimated that it will double in the next two years. It represents about 10% of all pharmaceutical sales worldwide.
30% of medicines in Russia and some countries in Africa, Asia and Latin America are counterfeit. In wealthy nations this figure is approximately three percent.
In the United States this equates to eight million packs of medicines worth approximately $975 million a year.
Approximately 25% of all emails – 15 billion messages a day – are spam advertising drugs. 50% of medicines offered by websites that conceal their physical addresses are fakes. Counterfeited, diverted, and diluted medications make more illicit money than cocaine and heroin.
In 2005, more than 500,000 single doses of fake medicines were discovered across Europe. In 2006 this number had shot up to 2.5 million. Only because fake drugs have spread from local markets to more global outlets, aided by the rise of the internet, has the world recognized the magnitude of the problem.

Photo Above: This machine is manufacturing fake drugs.

WHO & IMPACT

In February 2006, WHO created first global partnership known as International Medicinal Products Anti-Counterfeiting Taskforce (IMPACT). It is made up of all 193 WHO Member States on voluntary basis. The goal is to improve coordination and harmonization across and between countries so eventually production, trading and selling of fake medicines will cease.

IMPACT focuses on following key areas:
Looks at existing laws in countries.
Provides effective models countries can use.
Develops set of principles for establishment of appropriate legislation and penal sanctions.
Coordinates action at local levels between health authorities, police, customs, and judiciary institutions to ensure proper regulation, control, investigation and prosecution.
Helps countries with weak regulatory systems to strengthen them.
Comprised of five working groups to combat the spread of counterfeits:
- legislative and regulatory infrastructure
- regulatory implementation
- enforcement
- technology
- communication

The United States and Fake Medicines

The US is a lucrative market for counterfeiters of medicines and medical devices. This is because of high prices, a large market, widespread internet connectivity, and complex supply chain. Counterfeits are not normally manufactured in US. They are distributed through online pharmacies, most of which are outside the United States.

50% of medicines sourced from websites that conceal their physical address are counterfeit. These websites advertise and supply medicines illegally, with no prescriptions.
The fake drugs are discovered in the regulated supply chain, through licensed wholesalers, parallel traders, and pharmacies.

Thus, counterfeit medicines reach patients necessitating batch recalls. Fake medicines found in US regulated supply chain are designed to deceive pharmacists and patients into believing that they are genuine. Often only laboratory analysis reveals counterfeit product.

ATL Security Note: the need for lab analysis can be reduced by the use of a mixed and rotated “layered” security approach in labels and packaging. Invisible forensic digital markers can authenticate the product as genuine from virtually anywhere in the world.

Counterfeit medicines discovered in US typically contain reduced amount of active
pharmaceutical ingredient, or wrong ingredient, or no ingredient.

All counterfeit medicines are dangerous.

There are also reports of counterfeit medical devices discovered in US, or seized on their way to US.
Drug counterfeiting occurs less frequently in the US due to strict regulatory framework that governs production of drug products and distribution chain, and enforcement against violators.
The FDA works to ensure overall quality of drug products that consumers purchase from US pharmacies remains high.
The FDA advises pharmacists, physicians, and other healthcare professionals on drugs most likely to be counterfeited and how to identify them.

A suspect patient may have received counterfeit drug if:
He has unexplained worsening of medical condition or unexpected side effect.
He reports drug tastes or looks different, tablets chipped or cracked.
He experiences unusual burning at injection site.

Photo Above: Are you willing to keep taking drugs that are not authenticated as genuine? Will you do this until “death do you part?”

The Internet

Online pharmacies offer benefits of convenience, privacy, and (often) cheaper prices.
Many online pharmacies appear reputable and similar to legitimate retail pharmacy websites BUT sell fake pills that:
- do not contain medicine approved by regulators.
- have doses that are too strong or too weak.
- contain dangerous ingredients.
- aren’t manufactured using safe standards.
- aren’t labelled, packaged or shipped properly.
- are out of date.

Online pharmacies flourish because the public cannot get many new medicines for cancer, dementia, or influenza from publicly funded services. Many sites connected to other sites and have multiple links making investigation difficult. There are jurisdictional challenges as regulatory and enforcement issues cross international lines. The system is difficult to regulate – but governments can do more to warn public of the dangers.

India

India accounts for approximately one-third of counterfeit (fake, diverted, or diluted) drugs.
The EC claims India largest source of 2.7 million counterfeit drugs was seized by its customs in 2006.
India is the number one source of counterfeit medicines, followed by UAE and China.
India’s existing regulations pose little deterrence to unscrupulous drug vendors.

India is to introduce the death penalty for sale and manufacture of fake and counterfeit medicines that cause grievous harm. The minimum prison sentence is to be increased from five to ten years. There will be higher fines for those convicted for trading in fake drugs.

Drug regulatory officials are often in collusion with manufacturers of fake medicines.
It is against the law to sell fake drugs for domestic use, but no regulatory requirements apply to India’s export market.
Common fake drugs are antibiotics, drugs for tuberculosis, malaria, and cough syrups, as well as ingredients for lifestyle drugs.
Exportation of Active Pharmaceutical Ingredient (API) plays integral role in the manufacture of counterfeit medicines.

ATL Security Note: the use of a mixed and rotated “layered” security approach in labels and packaging works just the same when protecting the public for the purity of API (Active Pharmaceutical Ingredients). Invisible forensic digital markers, color-shifting inks, and other covert features can protect the public by ensuring the API are genuine. This is commonly known as maintaining the “pedigree”.

During first six months in 2005, more than 250kg of sildenafil citrate, Viagra’s active ingredient, were exported from India to Europe. Out of one kilogram sildenafil citrate, approximately 14,000 tablets of counterfeit Viagra-pills can be produced. If sold at normal market price of genuine Viagra a profit of up to 2,000% could result.

Photo Above: Real and fake drugs, side by side. Which would you take?

China

In China, between 200,000 and 300,000 people are estimated to die each year because of counterfeit or substandard medicines. The current baby formula incidents are a sad reminder of the human pain and suffering.

China has 80,000 chemical companies, and the FDA does not know how many sell ingredients used in drugs consumed by Americans. China exports “drug ingredients” to customers in 150 countries.

China’s State Food and Drug Administration is not responsible for regulating pharmaceutical ingredients manufactured and exported by chemical companies.
Corruption and lack of protection for whistleblowers undermines China’s attempt to establish a more rigorous drug regulatory system.

In 2007, a series of scandals involving counterfeit pharmaceutical exports led to intense international pressure on the Chinese government. This resulted in conviction and subsequent sentencing to death of the country’s two top drug regulators for accepting bribes.
Some counterfeiters have the same equipment used by pharmaceutical companies.
Cases have occurred of pharmaceutical laboratories that manufacture genuine drugs during business hours and produce counterfeits at night.
Counterfeiters have set up companies that provide service of disposing of expired medicines, thus they obtain real expired medicines that they repack and re-label.

ATL Security Note. Repackaging and relabeling (as described above) could be detected if an invisible forensic code was used in security packaging for the pharmaceuticals. If this covert technique was used, the break in the pedigree could be discovered before the consumer is harmed.

Photo Above: Fake hologram (left), and genuine hologram (right).

ATL Security Note. The following is a portion of the FDA’s conclusions from 2006: “The FDA’s vision of a safe and secure prescription drug supply chain is based on transparency and accountability by all persons who handle the prescription drug throughout the supply chain. With the implementation of the pedigree regulations in December 2006, the FDA expects that supply chain stakeholders will move quickly to adopt electronic track and trace technology, implementing RFID or an alternative track and trace technology in a phased-in approach. Although there are important issues that still need resolution, these issues should not hinder the forward progress and momentum toward widespread adoption. In the meantime, the FDA believes that public health would be better protected if all stakeholders work cooperatively to enable all distributors to pass pedigrees.”

The 2006 Report also considered several technical issues related to adoption of electronic track and trace technology that were perceived as obstacles to implementation and are in need of resolution. These include:
Mass serialization and unique identification of each drug package; and Universal pedigree with national uniform information.

As a brand owner ATL believes that you can protect the public by maintaining a record containing information regarding each transaction that results in a change of ownership of a given drug or pharmaceutical ingredient. This includes its sale by the manufacturer, through the wholesalers, distributors, and pharmacies.
As a brand owner, ATL can work with you to develop:

Lot or batch codes;
Integrated Mass Serialization;
2D DataMatrix Codes;
Forensic (invisible, non-degradable, nano-molecular markers);
Many other covert techniques.

In the 1950′s, when W. Edwards Deming tried to teach U.S. Manufactures about statistical quality control, he was not listened to. At the time, the stigmas of the past (as well as arrogance and ignorance) lived within the powerful decision makers in this country. Dr. Deming went on to huge success in Japan. He believed in quality before it was a buzzword.

“We are here to make another world.” W. Edwards Deming

Photo Above: W. Edwards Deming.

I believe that U.S. pharmaceutical manufacturers (and other brand owners) must protect the public from harm by providing safety and security for the genuine purity of their products. The citizens of the world must demand this.

“We must not inhibit our forward thinking by the comfort levels of the past. If something is not working, you must fix it, repair it, or invent a new paradigm. If you don’t, how many people are you willing to harm for the sake of a few dollars?” Donald J. Dobert, President, ATL.