If you think your prescription medication is pure and untainted, think again. I was at my pharmacy the other day picking up a prescription for myself and my wife. My hay fever had really been getting to me, so I thought I’d pick up some Sudafed, or
Pseudoephedrine HCL. I went over to grab a box and – no box. Instead, there was a card that I had to take to the pharmacist because this was now kept in the back.
After I gave them two forms of identification, I had my Pseudoephedrine HCL. It turns out that Pseudoephedrine HCL is used as an ingredient to make methamphetamine, and is now tightly controlled by the pharmacies. I got to thinking, if a pharmacy is so tight on Pseudoephedrine HCL, the prescription medications it’s doling out must be super safe.
What I found was that this assumption was not only wrong, it was astounding. It turns out that the prescription medications I have been taking to get or keep me well may be making me as sick as the illness it treats.
The Pharmaceutical Chain
I assumed the following:
• Pharmaceutical companies manufacture medications.
• These medications are shipped to pharmacies through regulated distribution.
• Tightly controlled distribution ensures quality and prevents adulteration.
There is actually an estimated 400 – 6,000 wholesalers who act as the middlemen, buying and selling medications as arbitrage. Stockpiling of drugs to reduce supply may occur and it can drive up prices. These medications may be released when prices escalate with little or no regard for safe storage or expiration dates to protect the consumer.
In some cases, fraudulent medications are repackaged and resold as manufacturer items. Some expire and are repackaged with new expiration dates. There have been reported instances where medications whose potency and effectiveness are affected by the elements have not been properly stored. When this adulteration occurs, the chemical components can break down render the drugs ineffective at best, and potentially harmful in a worst case scenario.
The proliferation of this secondary market that buys and sells for profit with little regard to the integrity of the medications has given rise to what is called the ‘diversion market”, and, as was concluded in the First Interim Report of the Seventeenth Statewide Grand Jury (Florida Case SC02-2645) in February, 2003, the movement of drugs "up, down and sideways through the distribution system… creates opportunities for adulterated drugs that have been diverted from other sources to enter the system".
What does this mean? It means that all those spam emails you receive for Viagra, Cialis, etc… you know, those medications you would never buy from an unreliable source – may be showing up in your prescription medications!
You just don’t know.
The Case of Cardinal Health
There are three major pharmaceutical wholesalers, Cardinal Health Inc, McKesson Corp. and AmerisourceBergen Corp. They “touch” between 80 to 90% of the prescriptions dispensed in this country. The State of New York attorney general's office subpoenaed all three major wholesalers in April of 2005.
On December 26, 2006, the Attorney General of the State of New York Medicare Fraud Control Unit and Health Care Bureau entered an agreement, in the matter of Cardinal Health Inc., an Assurance of Discontinuance to Executive Law § 63(15). Cardinal Health paid $11 million dollars, but it is the results of the findings contained in this agreement that are alarming.
In this agreement, the attorney general’s office found a pattern in which Cardinal knew or should have known that adulterated drugs had entered the system, and it did not take the steps to ensure the pharmaceuticals in the distribution chain were safe. The use of Alternative Source Vendors (ASV’s) for increased profit was cited by the attorney general’s office as well.
In the agreement, it states:
• ‘…In March 2004, Cardinal realized it possessed an anabolic steroid product that customers might perceive as high risk… It sought to avoid such customer concerns by transferring this product from its trading company, which was known for buying from ASV’s to its ‘divisions’ which customers perceived as selling pharmaceuticals purchased from manufacturers. A Cardinal employee sent an e-mail to the head of the Trading Company, noting a substantial inventory in ‘an anabolic steroid that is on the restricted list due to potential counterfeit. There is plenty of room to pass this product to the divisions. What are your thoughts on moving this product to the divisions? The reply e-mail instructed simply: ‘Go ahead and move it.’
• From May 2001 through May 2002 ‘Cardinal purchased drugs on the Secondary Market that later turned out to be counterfeit… over 10,000 units of counterfeit Procrit… Cardinal, still unaware that the product was counterfeit, sold some of the counterfeit Procrit to its customers…’
• ‘…Cardinal repeatedly sold pharmaceuticals to customers that it knew or should have known were diverting pharmaceuticals… Cardinal made numerous sales of pharmaceuticals to a Nevada company which purported to be a ‘closed door’ pharmacy that served only nursing homes. In a routine pattern, the Nevada company placed two orders at the same time. One was for products likely to be needed by the stated… nursing home residents… The other was for much higher quantities and included products unlikely to be needed by nursing home residents… Investigation has shown the company dispensed the products on the small-quantity orders to nursing home residents and it transferred the products on the large –quantity orders to an affiliated wholesaler for resale on the Secondary Market.’
• ‘Cardinal made ‘third party’ returns to manufacturers on behalf of other wholesalers regardless of where the wholesaler had purchased the product… Such practices support the Diversion Market by giving unscrupulous customers an incentive to divert drugs and then ‘return’ them for full credit…’
In his December 26, 2006 press release, then Attorney General and now Governor Eliot Spitzer stated:
‘…Secondary market trading is not illegal on its face, but can create opportunities for the introduction of unreliable drugs, including counterfeits, into the marketplace. In recent years, there has been an increase in the number of cases of counterfeit drugs in the American supply chain. Secondary market trading also can create an opportunity for companies to divert drugs from their intended distribution channels. Diversion into the secondary market, often to take improper advantage of manufacturer discounts, can begin a series of trades from wholesaler to wholesaler that makes it difficult to trace the origin of a drug and impossible to ascertain its authenticity.
The investigation determined that Cardinal purchased drugs from certain alternate source vendors, despite risks associated with buying from those vendors, to take advantage of higher available profit margins. Cardinal also sold pharmaceuticals to certain customers even in the face of evidence that those customers may have been illegally diverting the drugs outside their intended channels of distribution…’
So, if you were like me, and you assumed that these distribution channels and chains of custody were tightly controlled and regulated, you now see that there are ample windows of opportunity for fraudulent and adulterated prescription medications to enter the market and show up at your local pharmacy.
When I go to that local pharmacy, I stand in line five feet away from the customer being helped to ensure their privacy. I sign a HIPPA required statement stating that I have read these HIPPA requirements. I get child proof caps to protect my kids. And I sign away everything else for pseudoephedrine HCL.
Yet, the prescription I am taking may or may not be the medication I need, and may be making me sicker.
How good are my drugs? I don’t know.
Where did they come from? Who knows.