In the fall of 2012, many Americans who had never heard the term “compounding pharmacy” became familiar with it after hundreds of people across the country were infected by epidural steroid injections of medication prepared and packaged by the New England Compounding Center.
The Centers for Disease Control investigated and found that the steroid compounded by the pharmacy was contaminated with mold, which caused fungal infections in many patients, including abscesses and fungal meningitis. The compounding pharmacy had shipped the affected medication to more than 70 health-care facilities in 23 states, resulting in an outbreak of infections in 19 of those states. The infections resulted in over 60 deaths.
Regulation of compounding pharmacies
The practice of pharmaceutical compounding is used to create a custom medication by combining the appropriate ingredients to fit a patient’s particular needs. The pharmacies that engage in this practice are not regulated by the Food and Drug Administration, but by the state pharmacy boards of the individual states in which they are located. Following last year’s deadly outbreak, the FDA has been urging state boards to make sure that these pharmacies are meeting quality and safety standards, according to an article published by Time.
Latest recall
On August 11, a Texas compounding pharmacy, Specialty Compounding, LLC, issued a voluntary recall of all of its sterile products after 15 people contracted bacterial bloodstream infections after receiving injections of a mineral supplement manufactured by the company. This is the most recent recall by a compounding pharmacy. In addition to the Texas company’s recall, according to USA Today, two Illinois-based pharmacies and one in Michigan have recalled products since June. Prior to that, the FDA inspected 31 compounding pharmacies and found objectionable conditions in all but one of them.
Pending legislation
Despite the steps taken to recall these dangerous products, people are experiencing very real and life-changing injuries when they take the contaminated medications manufactured by compounding pharmacies. Several states have passed bills this year to deal with the problem. A bill pending before the California legislature sets forth requirements for the issuance or renewal of a sterile compounding pharmacy license. Congress is also considering the passage of a bill called the Pharmaceutical Quality, Security and Accountability Act which is meant to improve the safety of compounded drugs.
In addition to legislation, there are over 400 lawsuits concerning the injuries caused by last year’s contaminated steroid injections, according to NBC News. While not specified, patients who become ill as a result of the infections may seek compensation from the pharmacy for lost wages, medical bills and pain and suffering. Family members of those who succumbed to their infections may also sue to recover for the wrongful death of their loved ones.
If you or a loved one suspect that you may have been injured as the result of a bad drug from a compounding pharmacy, or any bad drug, you should seek legal help from a lawyer who has experience in medical malpractice claims.
