The Pedigree Laws, Where Are My Emergency Drugs?

The
"new" Pedigree law requires that specialized records be maintained
and provided for all drug purchases. A drug pedigree is a record of every
company and/or person that handles a drug at any time from the day it was
manufactured to the day it was delivered to the clinician or end user. On
December 1, 2006 the Federal Pedigree law went into effect. The Prescription
Drug Marketing Act of 1987 (PDMA) and amended by the Prescription Drug
Amendments of 1992, established requirements to increase safeguards to prevent
the introduction and retail sale of substandard, ineffective, and counterfeit
drugs in the U.S. drug supply chain.

Not that
this has been a huge problem, actually. There have never been more than 58
counterfeit drug cases
opened by the FDA in any one year. Few of those ever
impacted the normal supply chain. They were mostly Internet cases. The impact of
Pedigree Laws on EMS will probably be to create confusion, delays, and increase
the cost of buying drugs. For now, the pedigree requirements of the Prescription Drug
Marketing Act (PDMA) are on hold. This is a big loss for the FDA and a big win
for secondary wholesalers.

from the Wall Street Journal

"In a surprising decision that strikes a blow against Food and Drug
Administration efforts to curb counterfeit drugs, a federal judge granted an
injunction that delays part of a long-stalled drug law that was to have taken
effect Friday of last week.

Yesterday, U.S. District Court Judge Joanna Seybert of the Eastern District
of New York sided with a group of drug wholesalers who argued that the law is
in breach of equal protection and due process because it requires certain
recordkeeping of some wholesalers but not others, according to lawyers for both
sides of the case."

The driving energy of the Pedigree Laws is to prevent the US sale of fake or foreign drugs. The drugs
most likely to benefit from these protections are high profit drugs like
Viagra, and high volume drugs. Nobody has an interest in knocking off a
two-dollar preload of epinephrine. That is why the areas targeted for first
year enforcement emphasis are those “most vulnerable to counterfeiting and
diversion.”

Under the pedigree
requirement, each person who is engaged in the wholesale distribution of a
prescription drug in interstate commerce, who is not the manufacturer or an
authorized distributor of record for that drug, must provide to the person who
receives the drug a pedigree for that drug. In EMS, most distributors are
considered wholesale distributors under the PDMA. They do not sell the drug
directly to the patient. They sell the drug to your Department or more
specifically, to your Medical Director.

FDA’s pedigree law was
written in 1988 and signed into law by President Reagan. It was stayed or
postponed repeatedly up until December 2006. One reason for the delay was an
industry move towards RFID tracking, the ultimate technological solution for
maintaining drug pedigrees. But RFID technology still has a few remaining
glitches that have delayed implementation. So the Federal Government has
decided to implement the law now using paper-based & web-based systems,
which went into effect December 1rst, 2006.

Nevada and Florida are now
the only states with a pedigree law currently in effect. Florida’s law took
effect on July 1, 2006. California’s Pedigree Law is scheduled to be in effect
January 1, 2007. Some drug distributors have stopped selling in Florida,
leaving EMS Agencies wondering where their drugs will come from. Many have not
yet figured out how to comply with the law. Some of the largest drug
distribution companies such as AmeriSource Bergen have stopped selling to
distributors who sell in Florida.

Many
have expressed concerns that it the Pedigree Laws will ultimately mean fewer
distributors and higher prices. State EMS administrations are just now trying
to get a handle on the issue. Some EMS drug distributors have either limited or
stopped selling drugs entirely in those areas first impacted, such as in
Florida. For the next few months our industry will be learning about and
developing an understanding of these new regulations. Until then, you can
expect a certain mount of confusion, higher prices, and more limited
availability in the EMS drug supply chain. If you do have a drug supply
contract in effect, you may wish to confirm your current availability and
pricing. In the meanwhile, I suggest those interested follow the blog of
Adam J. Fein, PhD at Drug Channels for
further developments.

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About Dan White

I'm a retired Paramedic and EMS Instructor with 35 years EMS and emergency medical product experience. I love canoes, cars and EMS. I write about EMS Technology on the Paramedic Blog, the Insights on Innovation column for EMS1.com, on AmbulanceWorld.com and Multibriefs.com. I work for Intersurgical, Inc. managing EMS sales and distribution. I can be reached directly at 573-240-0002. Follow me @Paradan on Twitter
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2 Responses to The Pedigree Laws, Where Are My Emergency Drugs?

  1. Nae says:

    Hi Dan ~
     
    Just wanted to jump in and wish you the merriest and sweetest Christmas ever.  Stay well and have fun!
     
    God bless you and keep you,
     
    Nae  :o)

  2. Nae says:

    Hi Dan~
     
    Did Santa find your place?  I told him that it was really important that he make a special stop just for you!  I also hope that you had a wonderful time bringing in the New Year, and that it was blessed with great laughter and love.
     
    May the Lord continue to bless you with wisdom; you are an awesome teacher!
     
    God bless you and keep you,
     
    Nae  :o)

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