New Report Documents A Decade Of Safety Violations By Compounding Pharmacies

NJPIRG

TRENTON– The contaminated drug that caused last fall’s fungal meningitis outbreak, killing 55 people nation-wide and sickening 51 New Jerseyans, is just the tip of the iceberg of an industry-wide problem, according to a new report released today by NJPIRG. The meningitis outbreak was simply the latest and deadliest in a long line of errors and risky practices by compounding pharmacies.

“Consumers should always be confident that their drugs are safe and effective, regardless of whether their drugs are manufactured at a compounding facility or a pharmaceutical company. Our prescription drugs should not lead to the illness and death of our loved ones,” said Jen Coleman, NJPIRG Advocate.

Traditionally, compounding pharmacies have engaged in the practice of customizing a medication for a particular patient – such as altering the dosage or turning a pill into a liquid for patients who have difficulty swallowing. But now, large compounding pharmacies are behaving exactly like drug manufacturers. Although they manufacture drugs in bulk, large compounding pharmacies do not conduct rigorous testing, nor do they adhere to safe manufacturing processes that pharmaceutical companies are required to implement. Instead they are exploiting legal loopholes in the law to escape the necessary safety standards and oversight. 

The report, “Prescription for Danger,” analyzed more than 40 warning letters issued by the Food and Drug Administration (FDA) to compounding pharmacies from January 2002 to December 2012. Each firm was cited for multiple violations of the Food, Drug, and Cosmetic Act, such as making new drugs that have not been tested for safety and effectiveness, and making drugs in unsanitary conditions.

The report highlights some of the most blatant violations by compounding pharmacies, including:

•    In 2009, Hopewell Pharmacy in Hopewell, New Jersey, was found to be using a solvent called diethylene glycol monoethyl ether in sterile injections used for the treatment of varicose veins. This ingredient is normally used in industrial cleaners and is not approved by the FDA for use in drug manufacturing.

•    In 2006, Pharmacy Creations was discovered to be illegally producing adenosine-5-monophosphate, a drug that can be used for nerve pain. This drug was withdrawn from the U.S. Market in 1973 by the FDA as it was not considered safe or effective. The pharmacy was also found to be producing Domperidone capsules and Polidocanol injections under unsterile manufacturing conditions, potentially producing contaminated drugs.

“Congress must give the FDA the authority it needs to ensure that drugs made in compounding pharmacies are safe,” said Coleman. “We must never repeat the avoidable tragedy of having contaminated and unsafe drugs on the market again.”

New Jersey’s Attorney General has more recently addressed the safety of compounding pharmacies, after a March 2013 nation-wide recall of contaminated products distributed by Tinton Falls, NJ compounding pharmacy Med Prep Consulting. The Attorney General is currently seeking revocation of licenses for both the pharmacy and Med Prep’s pharmacist-in-charge.

“The findings highlighted in this report are alarming, as are the more recent incidents of contaminated products compounded by Med Prep Consulting, Inc. and New England Compounding Center,” said Attorney General Jeffrey Chiesa. “In response to these concerns, the New Jersey Division of Consumer Affairs is drawing upon new resources to supplement its already robust inspections of this industry. We are taking a comprehensive look at New Jersey’s compounding pharmacies and will act immediately on any violations that appear to threaten public safety.”

The report is available at http://www.njpirg.org/reports/njp/prescription-danger

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The New Jersey Public Interest Research Group is a nonprofit, nonpartisan public interest advocacy organization that takes on powerful interests on behalf of its members, working to win concrete results for our health and well-being. www.njpirg.org