Prevent Medical Error
P.O. Box 247
Portland, ME 04112

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A Message from the Founding Director

While reviewing a pharmaceutical subcontractor's Securities and Exchange Commission (SEC) filings linked to shortages of an injectable drug in my protocol,  I discovered that the drug was adulterated. The FDA had inspected the subcontractor's plant and issued an FDA Warning Letter to the company:

FDA investigators documented serious violations of current GoodManufacturing Practice Regulations (cGMP) (Title21, Code of Federal Regulations, Parts 210 and 211). These violations cause your drug products to be adulterated within the meaning of
Section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act (the Act). (1)
http://www.fda.gov/foi/warning.htm
 

Despite contamination issues, there were no apparent drug recalls or attempt to inform or adequately respond to treating prescribers and patients. Instead, contract terms were changed to limit drug returns and/or help stem financial losses. This appears to have caused these adulterated vials to be stockpiled, dispensed, and over-billed for increased profit. Several of my vials were apparently diverted into the gray market and tampered with before they were distributed to my pharmacy.

All of the cardinal warning signs of an unfit dispense were present. Unfortunately, transfers of care, misinformation and inadequate response on the part of some combined to cause treating providers to misinterpret and misdiagnose these important signs and symptoms. The moment that I learned it was adulterated, the drug prescribed to save me turned into a drug that had caused me harm and continues to cause cascading harm. I had injected that harm almost daily for years.

My own cascading harm continues to evolve and includes substandard drug dispenses that are under ongoing inquiry. Past dispenses include an adulterated prescription that my health insurer Anthem (part of Wellpoint) pressured my physicians into prescribing. Although listed and billed as a preferred drug on their drug formulary, the antibiotic had been recalled and discontinued.

Patients, providers and others who try to help stem the cascading harm caused by adulterated prescriptions continue to face retaliation, exploitation and financial ruin. Instead of providing assistance, some entities may allow medical claims to be over-billed or otherwise incorrectly billed by certain providers and/or contracted middlemen. If the provider and/or patient tries to report suspected drug safety issues to the appropriate authorities, learned intermediaries may try to intimidate or otherwise entrap them into misstating and/or otherwise divulging privileged information.

Surviving patients may be patient dumped and often have difficulty finding and paying providers to diagnose and treat them. Many of these vulnerable patients wind up being victimized again by being forced into programs that provide taxpayer subsidies to health insurers, PBMs and certain others. Adulterated drug patients may be 'purged' from certain health insurance plans and/or otherwise pushed into social services programs, taxpayer funded health insurance programs, high-risk insurance plans, or otherwise left to pay skyrocketing premiums and out-of-pocket amounts that ultimately stem from FDA deemed adulterated prescription dispenses.

New medical error prevention regulations; taxpayer recovery strategies; and/or insurer subrogation rights and/or Coordination of Benefits (COB) clauses may give insurers, attorneys and certain government entities and others a financial incentive to knowingly allow adulterated dispenses.  Insurance  subrogation clauses often give these companies the right to intervene and recollect billed amounts and/or amounts awarded or otherwise provided to patients who seek  assistance and/or redress from cascading harm precipitated by adulterated drug dispenses.

Although patients are the victims of illegal prescription dispenses that are authorized and billed by health insurers and Prescription Benefit Managers (PBMs), 'the system' allows these organizations to receive taxpayer subsidies and also allows these prospective criminals to force their victims to give them their victims' compensation. I question how these corporate profits are legal and whether or not they violate RICO statutes.

My discovery of the first adulterated prescription turned into frustration when many of the systems designed to protect me and others failed all of us. So I started a nonprofit, Prevent Medical Error. With the support of a widening circle of people, cascading harm is evolving into a nonprofit mission to provide advocacy and ensure adequate response to those at risk of or suffering as a result of these and other illegitimate profit models. Our major focus areas include outsourced manufacturing and distribution of drug components and/or finished prescription drug dosage forms.

In the worst cases, victims of adulterated prescriptions receive life sentences or death sentences while the criminals who profit usually remain free and continue to receive bonuses and cash out stock options.

I can personally verify that in competent and compliant hands, prescription drugs give life; in the wrong hands, they can take it away. Although you may think pharmacy bottles hold only pills and tablets, patients and treating providers rely on each dispense to be laced with faith. To some, injectable drugs are merely vials filled with liquid, but to patients and treating providers across the country, these vials are filled with hope; they infuse life. Those who knowingly(2) profit from adulterated dispenses exploit harm to increase profit. They steal faith, hope and life from us.

Please help us get this back.

Anne Patenaude, Founding Director
Prevent Medical Error

ENDNOTES:
(1) In laymen’s terms, the definition of adulterate is to “make impure by adding extraneous, improper or inferior ingredients.” The FDA’s lengthy definition of adulteration can be found on its website at http://www.fda.gov/opacom/laws/fdcact/fdcact5a.htm.

(2) Food and Drug Administration (FDA) definition of knowingly: Federal Food, Drug, and Cosmetic Act CHAPTER I— SHORT TITLE
Section 1 . [21 U.S.C. 301] This Act may be cited as the Federal Food, Drug, and Cosmetic Act.
CHAPTER II—DEFINITIONS1 SEC. 201. [21 U.S.C. 321] For the purposes of this Act— 2
(bb) The term "knowingly" or "knew" means that a person, with respect to information—
(2) (1) has actual knowledge of the information, or (2) acts in deliberate ignorance or reckless disregard of the truth or falsity of the information. http://www.fda.gov/opacom/laws/fdcact/fdcact1.htm