Thursday, May 31, 2012

Drug Reimportation Stemmed As Counterfeit Adderall Warning Issued

       by Terri Bernacchi, PharmD, MBA,  Cambria Health Advisory Professionals  
Although the general public may be in favor of freely purchasing drugs online or from Canada, there are some good reasons why traditional regulatory controls of these products are a reasonable responsibility of the federal government.  That statement is coming from a “free-market” libertarian minded person! 
The problem is that our FDA cannot sufficiently assure that the contents of a tablet are pure and labeled as what they ACTUALLY are.   A tablet full of placebo or active ingredient (or poison, for that matter) may look identical.  Offshore counterfeiters have become very sophisticated. 
Consider two recent stories and make up your own mind: 
“The bogus version was discovered "by a consumer, who noticed misspellings on the fake product packaging," according to Denise Bradley, Teva Pharmaceutical's vice president of corporate communications….

Teva's authentic 30mg Adderall tablets are round, orange/peach in color and are imprinted with "dp" on one side and 30 on the other side of the tablet. The tablets are packaged in bottles. The active ingredients in authentic Adderall tablets are dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate. An analysis of the counterfeit tablets revealed they contained tramadol and acetaminophen, both used to treat acute pain, and they were in blister package.   

Not surprisingly, the ever-compromised Senator McCain completely misses the safety question demonstrated by the first article.  The National Association of Chain of Drug Stores applauded the defeat of the amendment but probably has a bias in perspective. http://drugstorenews.com/article/nacds-lauds-prevention-personal-importation-prescription-medications

The problem about reimportation is not about pricing!  It’s a REAL safety issue!   There are people outside of the reach of our laws and our country that would sell us cow feces and call it Viagra for $4 a pop if they could get away with it. Some structure is necessary to keep the bad guys from hurting us.  This may be one of those structures, in my opinion! 

Terri is the founder of Cambria Health Advisory Professionals.  Among her current clients:  a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders. a small special needs health plan as a 5 Star Consultant, and several other health related clients.  The thoughts put forth on these postings are not necessarily reflective of the views of her employers or clients nor other Health Thought Leader colleagues.   Terri has had a varied career in health related settings including:  9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago.   She has both a BS and a PharmD in Pharmacy and an MBA.