Contaminated Compounded Steroid Infects 13 Floridians
By Jennifer Wolack, // June 1, 2013
Legislation Pending In Congress
ABOVE VIDEO: News report on foxnashville about the West Tennessee pharmacy, The Main Street Family Pharmacy in Dyer County, which is at the center of another contaminated compounded steroid scare and has voluntarily recalled all of its sterile compounded products.
EDITOR’S NOTE: Last Fall, 55 deaths and over 740 cases of illness in 20 states were attributed to contaminated steroid injections distributed by the New England Compounding Center (NECC), and on Wednesday the Florida Department of Health (DOH) confirmed 13 cases of adverse reactions here in Florida associated with injections of compounded steroid preparations originating from the Main Street Family Pharmacy in Newbern, TN.
Fortunately, unlike the cases last year, which were the result of spinal steroid injections leading to meningitis, the cases currently identified in Florida have been associated with skin abscesses following intra-muscular injections of the compounded steroid, with no life-threatening complications so far.
Two of the four Florida healthcare providers identified to have received Main Street products, The Back Center of Melbourne and Dr. Parvash Banzal, are located in Brevard County and are working closely with the DOH to determine if there were any exposures and notify patients who may have been exposed.
In response to the tragic outcomes from the contaminated NECC product last year, the Congressional Health, Education, Labor, and Pensions (HELP) Committee held a legislative hearing in May of this year to address potential health threats from gaps in oversight for these types of compounding pharmacies.
For an in depth look at pharmaceutical “compounding,” including the “who, what and where,” existing quality and safety oversight, and proposed new legislation that establishes a much needed national uniform set of rules for compounding, we welcome as a guest columnist Jennifer Wolack, who is in her last year of study for her doctorate degree in pharmacy and presently rotating through Holmes Regional Medical Center.
BREVARD COUNTY • MELBOURNE, FLORIDA — In September 2012, the first case of fungal meningitis appeared as a result of contaminated steroid injections distributed by the New England Compounding Center (NECC).
The rapid response of each state’s Departments of Health, the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), enabled rapid notification of potentially exposed patients to seek immediate care. This tragedy resulted in 55 deaths and over 740 cases of illnesses in 20 states.
Unfortunately, this outbreak was not an isolated incident. In 2011, nine deaths were attributed to contaminated IV nutrition products, and in 2012, at least 29 patients suffered vision loss from contaminated sterile eye drug products.
COMPOUNDING INDIVIDUALIZED PHARMACEUTICAL CREATION
Compounding is the practice where a pharmacist tailors an individualized product for a specific patient’s medical need based on their prescription.
Compounded medications are both valuable and essential to patient care, and include, but are not limited to, sterile preparations such as parenteral (intravenous) nutrition, irrigations used in surgical procedures, chemotherapy, and antibiotic treatments that are not commercially available.
Nonsterile preparations are available in customizable dosage forms; for example, suspensions or suppositories can be prepared for children or the elderly who have difficulty swallowing tablets. Since injectable medications pose a risk of infection, to ensure safety, they must be prepared following very strict quality standards established by the United States Pharmacopeia (USP).
COMPOUNDING NOT UNDER THE FDA’s AUTHORITY
Compounding, in the traditional sense, does not fall under the FDA’s authority; it is overseen by State Boards of Pharmacy to ensure adherence to the quality standards. However, compounding has evolved to include more than traditional compounding. A lack of oversight has led to problems as the compounding industry has changed and grown.
The tragedy of the fungal meningitis outbreak revealed that NECC, while claiming to be a compounding pharmacy, was preparing medications in large batches to be shipped for individual patient use at a later date; a process more akin to manufacturing. Pharmacies that practice large batch compounding are considered high risk for contamination and other safety problems.
SOME COMPOUNDING PHARMACIES STONEWALLED FDA INSPECTION
Due to the FDA’s lack of enforcement authority, several of these high-risk compounding pharmacies inspected by the FDA following the meningitis outbreak purposely hampered the progress of the FDA’s inspections requiring court intervention. They attempted to deny access to their facilities and documentation. These inspections uncovered that there were serious lapses in procedures to ensure sterility.
BETTER COMPOUNDING REGULATORY OVERSIGHT IMPERATIVE
The FDA, National Association of Boards of Pharmacy (NABP), The Pew Charitable Trusts, The International Academy of Compounding Pharmacy (IACP), and The American Society of Health-System Pharmacists (ASHP) attended the legislative hearing held by the Congressional Health, Education, Labor, and Pensions (HELP) Committee in May of this year to address potential health threats from gaps in oversight for these types of compounding pharmacies.
The Pharmaceutical Compounding Quality and Accountability Act makes a clear distinction between traditional and non-traditional compounding pharmacies and addresses the issue of oversight for compounding. These changes will continue to allow the benefits of compounded medications while ensuring they are prepared with highest quality and standard by allowing proper authoritative oversight.
A brief description of the act and the changes it introduces are as follows:
- Traditional compounding pharmacies, those that prepare individualized product for a specific patient with a prescription will continue to be regulated primarily by the State Boards of Pharmacy. The non-traditional compounding pharmacies, which offer valuable services and products that are an important part of the healthcare industry, especially during periods of supply shortages, will be referred to as compounding manufacturers, which make sterile products with or without prescriptions and can sell their products across state lines. These will also include any compounding pharmacy that prepares large batches.
- The FDA will regulate compounding manufacturers and will require them to follow a national, uniform set of rules for compounding. Compounding manufacturers will be required to register with the FDA and disclose what products they will be preparing, and to compound their products under a pharmacist’s oversight and in compliance with Good Manufacturing Practices (GMP). For any serious adverse problems, they will be required to report the incident within fifteen days and follow up with investigations. An annual registration fee will cover the costs associated with FDA inspections, which will be scheduled by the FDA according to a risk-based inspection schedule.
BILL IMPROVES FED AND STATE COMMUNICATION
Communication between the FDA and the State Boards of Pharmacy was yet another barrier seen during the meningitis outbreak. The new legislation will enhance communication by establishing a point of contact at the FDA for State Boards of Pharmacy. This will allow the state agencies a means of communication if they determine that a pharmacy should be registered as a compounding manufacturer. In addition, the FDA will notify a State’s Board of Pharmacy within 15 days of any pharmacy determined to be a compounding manufacturer.
The Pharmaceutical Compounding Quality and Accountability Act will allow patients to get individualized care through compounded products while maintaining the safety and integrity of the products.
Your pharmacist is a committed and trusted partner in your healthcare, who is always available if you have questions or concerns about any of your medications.
ABOUT THE AUTHOR
Jennifer Wolack, a resident of Brevard County for 27 years, is a PharmD candidate attending the University of Florida, College of Pharmacy, currently on pharmacy rotations for the last year of her curriculum, and presently working with Stacey Baggett, PharmD at HRMC. She has thirteen years of combined experience in microbial forensics and chemistry, and looks forward to a career as a community pharmacist.