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Living with Autism


April 24, 2012

Counterfeit Prescription Drugs: An Alarming Threat to People with Autism and Epilepsy

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Approximately 25% to 35% of people with autism have seizures, depending on what study you read. (Some studies state up to 40%).

People with autism and epilepsy rely on pharmaceuticals to control potentially health damaging and life threatening seizure activity. 

As if parents of autistic children with epilepsy don’t have enough stress, now we need to worry about the growing threat of adulterated and counterfeit medications. Awesome.

According to news reports, upwards of 10 percent of drugs worldwide are counterfeit, and in some countries more than half the drug supply is made up of counterfeit drugs, says one FDA report.

According to a 2011 Interpol news release, during one special operation, custom authorities seized 2.4 million dollars worth of counterfeit drugs, including antibiotics and ANTI-EPILEPTIC pills, originating from 48 countries.

While organized crime is heavily involved in this pharmaceutical nightmare, they aren't the sole reason for adulterated or counterfeit medications. 

Pharmaceutical giant GlaxoSmithKline (GSK), maker of the popular epilepsy drug LAMICTAL, plead guilty to distributing adulterated drugs, according to a 2011 CBS news report. 

One would hope you could at least trust the ORIGINAL big pharmacy maker of the drug. 

As if GSK’s PR people are on a daily dose of Ecstasy, their website states, “GlaxoSmithKline helps people to do more, feel better and live longer.” Thank you for caring. 


* Majority of fake pharmaceuticals in U.S. are imported from China and India. But we are still buying pharmaceuticals from these countries. We are truly a brilliant country. 

* A great amount of fake prescription medications are smuggled into U.S. across Mexican and Canadian borders.

* Pharmaceutical drugs are compromised through pharmaceutical cargo theft.

Case in point: In 2011, thieves got hold of 9 pallets of the epilepsy drug Gabapentin, made by generic drug manufacturer Actavis, according to Securing Pharma.

The drugs were being moved by truck. At some point, driver decided to stop and get a pack of smokes. Not being the brightest guy, he left the truck running. 

That’s when unknown criminals, apparently much smarter than the known driver, hijacked said truck and sped off.

So, the first question you'd ask is: HOW did criminals know the truck had pharmaceuticals on board? They must have been following it, right? I mean, it's not like the average criminal is sitting on the sidewalk at a local convenience store, sees a big truck and goes, shit, bro, let's take it. 

It’s easy to track incoming pharmaceutical shipments.

In fifteen seconds, I found a site called Importers-directory.net.

Site shows an India based company’s (Aurobino) “Import shipment database details” revealing products destined for U.S.

For example, Citalopram (a drug prescribed to some autistic patients) tablets were set to arrive on a shown specific date, in Elisabeth, New Jersey.

On another site I found “Top export product information of Sri Aurobindo”, an India based company that manufacturers and exports generic epilepsy drugs to U.S.

Importing drugs via Bombay Air, Aruobino declared ‘mini tablet presses’  ‘pharmaceutical machinery’ and ‘equipment for production of Medi-Cal formulations’, along with “Blister Packing Machines.”

Shipments with "mini tablet presses' and "blister packing machines' have been hijacked or gone missing, giving criminals more chances to create counterfeit medications. 

Here's more: 

On import.genius.com/suppliers/m-s-aurobindo-pharma-ltd, you can see that in 2009, Aurobindo Ltd sent pallets of anti-epileptic drugs Levetiracetam and Lamotrigine to U.S. based drug manufacturer Greenstone LLC.

Shipment traveled from India and arrived at Charleston, South Carolina, with Greenstone LLC being the “Consignee” (person to whom shipment is delivered).

Shipment data lists a freight forwarder under “Notify Party”. So, actual drug company that sells the prescriptions isn't picking up the drugs. The shipment is picked up by "freight forwarders." 

Hiring freight forwarders is legit, but it shows how pharmaceuticals travel between many hands, are transferred, trucked or stored, thus vulnerable to theft or adulteration, before they eventually end up in a pharmacy and then inside some poor patient's body.

Go to drugs.com/imprints to see generic Keppra levetiracetam from India listed as ‘manufactured/repackaged’ by Greenstone LLC.

So, Levetiracetam (generic Keppra) one thinks came from U.S. really came from India, was then handled by some "broker", who then delivered shipment to another generic company, that then repackaged the drugs and sold them to U.S. pharmacies and hospitals. 

Many U.S. pharmacies provide generic drugs from Greenstone LLC.

Recall Citalopram shipped from India noted above? 

Turns out in March 26, 2011, Greenstone LLC recalled Citalopram 10mg Tablets (100-count bottle) distributed in the U.S. market.

Why?  Incorrect labels were placed on pill bottles: by a third-party manufacturer

Pharmaceuticals intended for U.S. citizens should not be passing through foreign, unsecured ports or between multiple manufacturers.

Every prescription drug sold in US pharmacies should be MADE IN AMERICA. 

There’s another scenario that plays out in counterfeit medication industry.

Compromise can begin when a pharmaceutical raw materials company sells tainted ingredients to a drug manufacturer

Once drugs are manufactured, they are sold to a drug wholesaler

Drug wholesaler sells to hospitals and pharmacies

Pharmacists must be alert to threat of counterfeit drugs, says a recent report from the American Pharmacists Association (March/April 2012). 

How do you spot a counterfeit pill? 

Sometimes, fake pills have bigger lettering, bolder colors or uneven imprinted numbers and letters. 

Or, be chipped or easily crumble. 

Or have strong odors, usually from toxic fillers like arsenic, ammonia and paint

In some cases, not even experts can visually tell the difference between counterfeit and authentic medications. 

In those cases, you'd need lab testing. 

According to a 2007, Science Daily report, " Immunochemists have devised a range of nanoscale materials that can be embedded in drug packaging or in the pills...to distinguish medicines from counterfeits." 

It's unclear how many drug manufacturers use this technology

Another generic manufacturer of Keppra was cited:

In 2011, the FDA sent Mylan Laboratories—a generic maker of Keppra— a warning letter, “During [our] inspection, we identified significant violations of Current Good Manufacturing Practice... for finished Pharmaceuticals... These violations cause your drug product(s) to be adulterated...”  

In 2011,  TEVA Pharmaceuticals, another generic maker of Keppra, was warned by FDA investigators. Warning: “...identified significant violations of Current Good Manufacturing Practice... violations cause your drug products to be adulterated... Your facility contains shared manufacturing areas where you produce potentially hazardous compounds in multi-product equipment... including drug products intended for the U.S. market”. Hazardous compounds. Wonderful! Thanks TEVA.

Again in 2011, FDA investigators discovered Dr. Reddy's— a Mexican generic production plant---had failed to “clean manufacturing equipment” or analyze the quality of active ingredients used to make their medications. 

Another threat to our nation's medications is rouge internet pharmaceutical companies selling adulterated and counterfeit medications. 

So now what? The reality is we can’t walk into a drug manufacturer, hover over machines to see if they're adulterating medications. That’s the FDA’s job. Nor can we detect fake drugs from infiltrating U.S. pharmacies. That’s medical personnel’s job. Nor can we stop cargo thefts. That’s US law enforcement’s job.

Here's what you can do:

1.    Examine every prescription bottle you get 

2.    Find name of drug manufacturer (usually in upper right corner).

3.     Check if manufacturer has been cited for chronic violations of Good Manufacturing Practices

4.    Check by googling name of drug manufacturer, along with words “FDA warning letter”. For example, “Teva and keppra" “FDA warning letter”. If there is something, it should come up

5.     Examine pills in every prescription bottle. They should all look the same. 

6.    Check number and/or letters on pill. They should MATCH the number/letters on BOTTLE (usually found on lower left side outside the bottle). 

7.    You can also visit Drugs.com. At top of page you will find “Pill Identifier”

8.    Type into “Search” the information imprinted on both sides of pill

9.    Peruse page until you spot “results from pill identifier.” Click this link, it should take you to pill you’re looking for

10.                       Pill identifier also shows ingredients of specific pill. This is important, since generic drugs have different ingredients that vary between drug manufacturers.





LokaSamasta said...

Nobody can fake a cannabis plant ;)

Anonymous said...

I've found that the pharmacist my son's Agency uses is always on the lookout for a bargain - so pills change every couple of months, even though the Rx stays the same. Twice (so far) he has been pushing pills imported from India, manufactured by plants either currently under citation/investigation or previously (repeatedly) cited for problems.

It's not just criminals - its criminal practice within the confines of the law - or, as we used to say in school, it's all good unless you get caught.

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