Are Compounding Companies Causing Harm Throughout Tennessee

A significant amount of focus has been placed on “compounding companies” as a result of the fungal meningitis outbreak that occurred in Tennessee back in 2012.  This outbreak was caused by a compounding firm in Massachusetts, the New England Compounding Center (NECC), which has subsequently closed its doors.  However, there is a lot of confusion about what a compounding firm actually does.

Many people who go to their doctor, receive a prescription, and have the pharmacy fill it do not realize that it may have been prepared by a compounding firm with little regulatory oversight.  Compounding firms typically manufacture or mix relatively small amounts of rare or infrequently prescribed drugs that are not available from large pharmaceutical companies.  These firms are not regulated by the Food and Drug Administration (FDA) and are not held to the same standards as other drug companies.  This means that the standards relating to how prescriptions drugs are developed, formulated, and tested do not apply to these companies.

When the New England Compounding Center was inspected after the 2012 fungal meningitis outbreak, it was discovered that there were many violations of the basic standards for maintaining manufacturing sterility in order to preserve the quality of the drugs.  There also were serious problems with how the custom doses were being prepared.  These problems are widespread in the compounding business and lead to serious medication errors.  A medication error may be any event that could have been prevented that involves patient harm or inappropriate use of a medication.  The medication at issue may be administered by the patient, another party such as a parent or caregiver, or a medical professional.

When the error occurs at a compounding company, it may have been caused by:

• Using substandard or contaminated active pharmaceutical ingredients;
• Preparing a prescription drug based on an incorrect formula;
• Maintaining liquid dosages at inappropriately high temperatures, which may lead to chemical changes in the liquid;
• Failing to maintain manufacturing equipment in a sterile manner;
• Mislabeling medication; and
• Labeling the medication with improper dispensing instructions for patient use.

Basic policies for maintaining a sterile environment, limiting the number of drugs being manufactured and stored at any one time, storing drugs in appropriate climate-controlled environments, and implementing a protocol for testing and verifying drug efficacy and identification before distribution are an easy means to prevent terrible tragedies like the fungal meningitis outbreak.

Tennessee does regulate the process of compounding, by defining what this means and requiring licensing by out-of-state firms that do business with in-state medical professionals and facilities.  However, this protection is limited because of the errors that occur at the compounding firm, which are impossible to regulate from a remote location.

In order to address the dangers that unrestricted compounding firms pose for the public, Congress has drafted a bill that will place these companies and the entire drug distribution system under the oversight of the Food and Drug Administration.  The Drug Quality and Security Act will be going to the U.S. Senate for a vote.

Although many medication errors caused by compounding firms cannot be detected by medical professionals, there are other errors where a simple review of the medication would alert the doctor, nurse, or pharmacist of the problem with the drug.  Therefore, responsibility for patient harm may lie with several individuals, facilities, or companies.

If you or a loved one has been harmed as a result of a medication error caused by a compounding firm or medical professional, the Tennessee lawyers with Bailey & Greer have the skill and expertise to serve as your personal legal team. Our Tennessee personal injury attorneys have the skills necessary to investigate these cases and identify those responsible for causing your injuries.  Call us toll free at 901-680-9777 to schedule your free and confidential consultation. At Bailey & Greer, we are small enough to care, big enough to fight, and experienced enough to win.