Government Regulations Hinder Quality Control and Harm Consumers

The tragic case of the tainted medication produced by New England Compounding Center, which resulted in at least twenty-five deaths and hundreds sickened, highlights a little-recognized danger inherent in government regulation. As David Brown reported:

“[Purchasing pharmaceuticals from compounding pharmacies is] like buying your electricity from a different supplier. It looks like you’re getting the same stuff, but evidently you’re not,” says a physician at one of the seven outpatient treatment centers in Maryland that received methylprednisolone from a contaminated lot from the New England Compounding Center. A pain specialist, he’s been using compounding pharmacies [which produce customized drugs] “for at least five years, closer to 10.” He spoke on the condition of anonymity on the advice of his lawyer.

He’s never really thought of compounding pharmacies as different, less regulated, under-the-radar enterprises.

“From our perspective, they look like any of our other vendors,” he said. “They’re licensed and inspected; they have nice, pretty Web sites and sales teams and inspections. They look no different from Upjohn.”

This doctor operated under the assumption that government regulators assured all product integrity, creating in his mind a false sense of security. If there were no government regulation, how would his thinking have differed? Where would physicians and patients turn for information on medications and drug manufacturers? As Stella Daily Zawistowski explains in “How the FDA Violates rights and Hinders Health”:

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FDA sends warning letter to Philly dye company, Abbey Color, about water problems in drug products POSTED: Wednesday, February 27, 2013, 11:47 AM

David Sell

Abbey Color, Inc., an industrial dye manufacturer in the Kensington section of Philadelphia, was sent a warning letter by the U.S. Food and Drug Administration that said the company failed to ensure adequate purity of the water used in drug products including those for eye exams.

Fluorescein is a sterile liquid dye used in eye exams that look at blood flow in the retina and choroid, the two layers in the back of the eye.

Eye drops are put directly in the eye to dilate pupils. With the patient's chin resting in the camera's chin rest, pictures are taken of the eye. Then the fluorescein dye is injected into a vein, usually near the elbow. A second set of pictures is taken as the dye moves through the blood vessels in the back of the eye.

The warning letter said the FDA inspected the facility on East Tioga Street from March 13-23, 2012. The company's reply to the FDA observations was not acceptable, the agency said.

"Your firm uses water in the final purification step of Fluorescein USP, an API [active pharmaceutical ingredient] intended for use in sterile drug products," the letter said. "However, your firm failed to demonstrate that your purified water system can consistently produce water that is suitable for use in the manufacture of this API.

"This is a repeat observation from the July 21-August 8, 2010 inspection. In your response to observations made at the 2010 inspection, your firm promised actions it would take to assure reliable water quality. However, those changes were inadequate, as you continued to get periodic out-of-specification (OOS) endotoxin and total organic carbon (TOC) test results."

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Kansas Adopting New Rules and Regulations, Hiring and Training Inspector, Additional Inspections for Holders of Nonresident Permit in Another State

Compounding Issues
Last year’s deadly outbreak of fungal meningitis linked to
spinal injections of a pain-relieving steroid product produced
by the New England Compounding Center in Massachusetts
raised serious questions about the oversight of compounding
pharmacies and the appropriate role for federal and state
regulators. The Kansas State Board of Pharmacy and Kansas
Department of Health and Environment participated in a Food
and Drug Administration (FDA) intergovernmental meeting on
December 19, 2012. There was discussion on whether the states
had the resources to provide oversight of pharmacy compounding
and whether there was a way to rebalance federal and state
participation in the regulation of pharmacy compounding that
would better protect the public health.
The Board is very concerned about whether federal preemptions
will be enacted that could possibly undermine the
Board’s authority by removing its oversight in this area. The
Board has implemented a plan that includes the adoption of
rules and regulations for compounding. The regulations have
been approved by the Department of Administration and are
currently at the Office of the Attorney General for review. The
Board has asked the Office of the Attorney General to expedite
these regulations. The inspectors are going to receive additional
training related to compounding, and the Board is going to
work with the National Association of Boards of Pharmacy®
and other states to share its limited resources. The Board has
also requested that Board staff seek approval for hiring an
additional pharmacist inspector.
If you hold a nonresident permit in another state, be advised
that your pharmacy may get an additional inspection from the
state in which you are licensed. Make sure that you know the
laws of each state that you are registered in related to office use
because many states do not allow this practice. The Board will
cooperate with any state that wants an additional inspection of
your premises.
It is the Board’s goal to address the compounding issues in
order to adequately protect the public’s health, welfare, and
safety.
Source Kansas Board of Pharmacy March 2013 Newsletter

Treat a Veterinarian Prescription Exactly as You Would a Physician Prescription in Kansas

If you are filling veterinary prescriptions and you have questions or concerns about the drug prescribed, it is important to contact the veterinarian for clarification. Lowering or raising the dosage or substituting medication may seriously compromise an animal’s health. Do not make changes to veterinary prescriptions without first contacting the prescriber because drugs affect animals much differently than humans. After contacting the veterinarian, clarification or any changes made to the original prescription should be documented on the back of the original prescription.

Source found at Kansas Board of Pharmacy March 2013 Newsletter