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Author Topic: Fake meds-"Bitter Pill"  (Read 3873 times)

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Offline alisenjafi

  • Member
  • Posts: 811
  • They say HIV comes from monkeys!
Fake meds-"Bitter Pill"
« on: June 11, 2006, 10:50:26 am »
So  just being adherent is not enough-
Inside the world of counterfeit drugs
Dateline's Chris Hansen investigates how fake prescription drugs have popped up at pharmacies— and how this can be stopped
• A dose of reality
June 4: As more prescription drugs are being sold on the Internet, a new problem has emerged: counterfeit medications. And now, those fake prescription drugs are popping up at drug stores. Chris Hansen has a Dateline Hidden Camera Investigation.

Margaret Glavin, who is in charge of enforcement for the Food and Drug Administration says there are things consumers can do to avoid counterfeits, like looking closely at their prescription drugs. Check—

— has it changed color?
— does it have a different taste or a different smell?
— are the pills cracked or chipped?
— does the packaging look as thought it's been compromised?
— is the label funny, on crooked, or different from what a previous label looked like?
This part seems a bit moot as you will see in the show.

By Chris Hansen
NBC News
Updated: 8:50 p.m. ET June 9, 2006
Update: Less than a week after Dateline’s broadcast about counterfeit medicines, the FDA has announced new rules to require prescription medicines to be tracked every time they change hands from the factory to the pharmacy. The new rules are scheduled to take effect in December 2006. Click here for more details. Below is Chris Hansen's Dateline Hidden Camera Investigation which aired Sunday, June 4, 7 p.m.

Chances are you didn't think twice about the last prescription you picked up from the pharmacy, trusting that the medicine in the bottle matches the information on the label. After all, America's drug supply is the safest in the world. But a dose of reality: as more and more drugs are being sold on the Internet, a new problem has emerged: counterfeit medications.
They look so real even pharmacists are being fooled.

And today in the NY Times:
F.D.A. Imposes Long-Delayed Rule to Require Tracking of Prescription Drugs

Published: June 10, 2006
Long-delayed federal rules requiring most wholesalers to be able to track prescription drugs from factory floor to pharmacy door will finally take effect in December, the Food and Drug Administration said yesterday.

The regulations, stemming from a 1988 law intended to combat counterfeiting by verifying a drug's pedigree, were originally drafted in 1999. But the F.D.A. had repeatedly put a stay on the rules because the drug industry said it lacked practical methods for tracking and tracing all of its products. Now, though, the agency said further delay of the "pedigree" rules as they are known was no longer justified because of the development of electronic tracking technology, particularly digital identification tags that can be scanned with radio waves.

Such tags have become small enough to embed in the labels of individual drug bottles and packages. The tags can store more information than bar codes and can be scanned from farther away. And in contrast to bar codes, bunches of them can be scanned simultaneously. Still, development and adoption of radio tags have been slowed by concerns on cost, reliability and security.

Dr. Randall Lutter, the F.D.A.'s associate commissioner for planning and policy, said many participants at a February hearing on the issue told the agency that the regulations were needed to spur investment in the radio tagging technology. "This decision to lift the stay is intended to provide that push," Dr. Lutter said at a news conference yesterday.

The F.D.A. had projected, based on industry forecasts in 2004, that the new technology would be widely deployed by 2007. But that timetable has fallen by the wayside. Only a handful of major pharmaceutical companies currently use radio tags on their products, and even in those cases the technology has not moved much beyond pilot programs. Pfizer has been applying the tags to all Viagra shipped from its manufacturing plant in France; Purdue Pharma has been using it on the painkiller Oxycontin; and Glaxo SmithKline recently began tagging Trizivir, an anti-AIDS drug.

The F.D.A. became an advocate for radio frequency identification, or RFID, after major consumer retailers like Wal-Mart, manufacturers like Procter & Gamble and the Department of Defense agreed to back standards for tagging in 2003 and to push for widespread adoption. The retail industry and Defense Department have focused primarily on tagging pallets and cartons of goods in their supply chains to avoid shortages and to increase efficiency.

But the drug industry faces a more difficult challenge in tagging individual items as a way to fight counterfeiting and aid in product recalls.

At this point, RFID advocates say that the biggest questions are not whether the technology can meet the drug industry's needs but which of two competing frequency standards to use and how fast it can be cost-effectively rolled out.

Most of the drug industry testing has been with older, so-called high frequency systems, but Wal-Mart and other major customers for the new technology have been supporting still higher-powered systems in the ultra high-frequency or UHF bandwidths.

Now a coalition of RFID companies including Impinj, Alien Technology, Symbol Technologies and ADT/Tyco have begun a drive to persuade drug makers to switch to UHF.

A remaining uncertainty the F.D.A. noted yesterday is the effect of the radio signals on biological drugs, which consist of purified proteins. While there is not yet evidence of such problems with the technology, the testing has been limited.

The F.D.A. said that its new regulations could be met with bar codes or even written documents as well as the radio tags, although it expects that the industry will eventually adopt the radio tags almost universally. States like Florida and California that have been introducing their own drug-authenticity rules have taken a similar position.

Counterfeiting is roughly a $30 billion global problem for the drug industry, involving 8 to 10 percent of drugs sold, according to the World Health Organization. Federal regulators say it is relatively rare in the United States but still a concern because the drug distribution system is far more convoluted and open to corruption than most Americans realize, and the sophistication of the counterfeiters has been growing.

The F.D.A. said that after many years of opening 10 or fewer investigations annually, the caseload jumped to 58 in the fiscal year ended Sept. 30, 2004, and that 32 more investigations have begun so far in fiscal 2005.

While some drugs move relatively directly to consumers from manufacturers through major wholesalers, several thousand secondary wholesalers and repackagers that break down bulk shipments into smaller containers play a major role in drug distribution. Such middlemen also buy overstocks from retailers and other wholesalers to resell. In some cases, they buy stolen drugs, supplies accumulated by addicts or drugs from patients who obtain more from their doctor than they need.

The F.D.A. regulations, as specified by Congress, exempt major wholesalers who get drugs directly from manufacturers through established contractual relationships. But if the exempt wholesalers buy the drugs from any nonexempt source, they must obtain the pedigree information and pass it on when they sell the drugs.

"You shut your mouth
how can you say
I go about things the wrong way
I am human and I need to be loved
just like everybody else does"
The Smiths

Offline J.R.E.

  • Member
  • Posts: 8,035
  • Positive since 1985, joined forums 12/03
Re: Fake meds-"Bitter Pill"
« Reply #1 on: June 11, 2006, 06:05:24 pm »
Hey Johnny,

 Long time no see !! Hope all is going well.  :)  Thanks for bringing this subject up. I had put a post up on the old forums, quite a while back on this. At that time, the article reported the Pharmacies in (I believe) New Jersey, New York City, And I also believe LA,California. Gave the cities and their addresses. Some of those that were listed were selling fake HIV medication. (edited)

Have a good one-------- Ray 8)
« Last Edit: June 11, 2006, 06:12:11 pm by J.R.E. »
Current Meds ; Viramune / Epzicom , 20 mg of Atorvastatin, 25 mg of Hydrochlorothiazide.
Amlodipine Besolate 5mg-- Updated 5/27/21 tested positive in 1985,.. In October of 2003, My t-cell count was 16, Viral load was over 500,000, Percentage at that time was 5%. I started on  HAART on October 24th, 2003.

 As of May 27th,21,  Viral load remains Undetectable

CD 4 @571 /  CD4 % @ 17 %


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