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Note: If this involves a medical issue, please contact your treating provider and report it.
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 a warning letter to the company:
The FDA eventually (and temporarily) halted manufacturing, but despite sterility issues and contamination, there were no apparent drug recalls, and no apparent attempt to inform or adequately respond to treating prescribers and patients. Instead, these adulterated prescriptions appear to have been stockpiled, dispensed, and over-billed for increased profit. Some vials were diverted into the grey market and counterfeited. Stockholders won judgments against the drug wholesaler and pharmaceutical subcontractor. The pharmaceutical subcontractor began outsourcing to India, and in the spring of 2007, they received a new FDA Warning Letter citing sterility issues and adulteration.
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 entities combined to cause my 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 personal cascading harm quickly evolved to include multiple dispenses of two other unfit prescription drug dispenses. These include substandard Indian manufactured generic drug dispenses manufactured by a company that is under ongoing inquiry. They also include dispenses of an adulterated prescription that my health insurer pressured my physicians into prescribing. Although listed as a preferred drug on their drug formulary, this drug had been recalled and discontinued.
Patients, providers and others who try to stem the harm caused by adulterated prescriptions continue to face retaliation. Surviving patients continue to have difficulty finding and paying providers to diagnose and treat them. Survivors of adulterated dispenses are often pushed into taxpayer funded health insurance programs, high-risk insurance plans, or otherwise left to pay higher premiums and increased out-of-pocket amounts based in-part on profiteering from unfit drug dispenses. New medical error prevention regulations and/or taxpayer recovery strategies may give insurers and others a financial incentive to allow patients to receive adulterated dispenses. Insurer subrogation clauses may give health insurers, Medicare, Medicaid and others the right to intervene and collect amounts awarded or otherwise provided to patients who seek redress.
My discovery of the first adulterated prescription turned into disillusionment when many of the systems designed to protect me and others failed us. I made a promise to never again be forced into the position of notifying treating providers that they unknowingly prescribed and dispensed unfit prescriptions. The nonprofit Prevent Medical Error was started, and 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 unsafe dispenses. Our major focus areas are distribution and outsourced manufacturing of Chinese drug components and/or U. S. prescription pharmacy dispenses from India. In the worst cases, patients who receive adulterated prescriptions receive life sentences or death sentences while the criminals who are knowingly responsible usually remain free.
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