W140 N9504 Fountain Blvd.
Menomonee Falls, WI  53051

Local: 262.255.6150
Toll Free: 800.444.5144
ATL Home
ATL

Donfucius Says: February 3rd, 2012. Random Bits Of Wisdom.

  1. “Since light travels faster than sound, isn’t that why some people appear bright until you hear them speak?” — Patti Molloy
  2. “Preach the Gospel at all times, and when necessary use words.” — Aaron Rogers Quoting Francis of Assisi
  3. “Diplomacy is the art of saying “Nice doggie” until you find a rock.” — Will Rogers
  4. “Before they invented drawing boards, what did they go back to?” — Patti Molloy
  5. “The way we’re going… if I called up another pitcher, he’d just hang up the phone on me.” — Any Brewers Manager
  6. “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
  7. “We’re fools whether we dance or not, so we might as well dance.” — Old & Wise Japanese Proverb
  8. “Blessed are the cracked – for they are the ones who let in the light.” — Donfucius
  9. “Good judgment comes from experience, and a lot of that comes from bad judgment.” — Will Rogers
  10. “I don’t mind how much my Ministers talk, so long as they do what I say.” — Margaret Thatcher

ATL
RSS

ATL's Anti-Counterfeiting Digest

Posts Tagged ‘digital forensic code’



You Bet Your Life – Part I. Fake Pharmaceuticals.

February 4th, 2010

FDA Warns Consumers about Counterfeit Drugs from Multiple Internet Sellers

If you purchase medications from sources that you do not know, and the product you take is purchased on the sole basis of “price”, then I believe you are playing a dangerous game of “you bet your life”.

The Food and Drug Administration (FDA) is cautioning U.S. consumers about dangers associated with buying prescription drugs over the Internet. This alert is being issued based on information the agency received showing that 24 apparently related Web sites may be involved in the distribution of counterfeit prescription drugs.
On three occasions during recent months, FDA received information that counterfeit versions of Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche Inc. (Roche), were obtained by three consumers from two different Web sites. Xenical is an FDA-approved drug used to help obese individuals who meet certain weight and height requirements lose weight and maintain weight loss.

Above photos: Counterfeit Xenical, complete with instruction sheet, blister pack with exp. date, and lot serial numbers. What’s missing? ATL’s security labeling/ packaging: This is an invisible (non-degradable) digital forensic code that cannot be duplicated by the counterfeiters.

Photos below: If your prescription medications are not authenticated as genuine, how do you know that (your prescription medications) were not produced (by counterfeiters) on equipment such as this?

None of the capsules ordered off the Web sites contained orlistat, the active ingredient in authentic Xenical. In fact, laboratory analysis conducted by Roche and submitted to the FDA confirmed that one capsule contained sibutramine, which is the active ingredient in Meridia, an FDA-approved prescription drug manufactured by Abbott Laboratories.
While this product is also used to help people lose weight and maintain that loss, it should not be used in certain patient populations and therefore is not a substitute for other weight loss products. In addition the drug interactions profile is different between Xenical and sibutramine, as is the dosing frequency; sibutramine is administered once daily while Xenical is dosed three times a day.

Other samples of drug product obtained from two of the Internet orders were composed of only talc and starch. According to Roche, these two samples displayed a valid Roche lot number of B2306.
Roche identified the two Web sites involved in this incident as brandpills.com and pillspharm.com. Further investigation by FDA disclosed that these Web sites are two of 24 Web sites that appear on the pharmacycall365.com home page under the “Our Websites” heading. Four of these Web sites previously have been identified by FDA’s Office of Criminal Investigations as being associated with the distribution of counterfeit Tamiflu and counterfeit Cialis.

At this point, it appears that these Web sites are operated from outside of the United States. Consumers should be wary, if there is no way to contact the Web site pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from your doctor is required. As a result, FDA strongly cautions consumers about purchasing drugs from any of these Web sites which may be involved in the distribution of counterfeit drugs and reiterates previous public warnings about buying prescription drugs online. Consumers are urged to review the FDA Web page at www.fda.gov/buyonline/ for additional information prior to making purchases of prescription drugs over the Internet.
The 24 Web sites appear on pharmacycall365.com.
AllPills.net
Pharmacy-4U.net
DirectMedsMall.com
Brandpills.comEmediline.com
RX-ed.com
RXePharm.com
Pharmacea.org
PillsPharm.com
MensHealthDrugs.net
BigXplus.net
MediClub.md
InterTab.de
Pillenpharm.com
Bigger-X.com
PillsLand.com
EZMEDZ.com
UnitedMedicals.com
Best-Medz.com
USAPillsrx.net
USAMedz.com
BluePills-Rx.com
Genericpharmacy.us
I-Kusuri.jp

If you are a brand owner, ATL can show you how to authenticate your products in the field. If you are a consumer, we suggest that you purchase only authenticated prescription drugs from reliable sources.

We thank the FDA for materials used in this article.

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