89 Percent of Mass. Pharmacies Fail Inspections
February 10, 2013—Boston, Massachusetts—According to a recent report from Boston.com, 89 percent of the so-called “specialty” pharmacies subjected to surprise inspection failed to meet safety standards. This news comes in the wake of a fatal outbreak of fungal meningitis last year linked to injections prepared by one Massachusetts pharmacy.
Compounding Pharmacies “Not Sterile”
Serious safety violations were found in almost half of the pharmacies, prompting an immediate shut down by the state. Another 21 were cited for minor violations. One pharmacy surrendered its license after inspectors found sterility issues in a room where injectable drugs were prepared.
The Department of Public Health began surprise inspections after a Framingham pharmacy was linked to an outbreak of fungal meningitis in steroid injections last fall. That tainted medication issue caused nearly 700 cases of illness and 45 deaths.
Critics of the pharmacies are not surprised at the findings. They have been advocating for stricter oversight for some time, saying that few of these compounding pharmacies observe safety precautions. They also warn that similar inspections in other states would probably reveal similar results. Many states do not even have safety guidelines for these manufacturers, resulting in a self-regulation that many feel is ineffective.
There is some evidence that unsterile conditions have led to the problems experienced by patients who are given injections and drugs from compounding pharmacies. Inspectors have found that “sterile” environments in these facilities often do not meet sterility standards generally accepted by the medical community, leading to contamination of drugs before they leave the manufacturer.
New Rules and Money Needed
Massachusetts recently enacted a new regulation that all inspectors must be licensed pharmacists with five years’ experience prior to inspecting other facilities. More money in the state budget, approved last year, also means that more inspectors are available to investigate complaints and conduct surprise inspections.
However, other states have not yet moved to upgrade their own inspection processes, nor have they budgeted more money to examine compound pharmacies. Critics worry that this may have the effect of simply causing pharmacies with sloppy safety practices to relocate to states where they will be held under less scrutiny. Since there is little federal oversight of these compounding pharmacies, patients in any state may not know that their medication is coming from a safe source and may be unknowingly exposed to the danger of infection.
What Should I Do If I Am A Victim of Tainted Medication?
Victims who have been injured by tainted medication have rights under product liability law. They are entitled to payment of medical bills, recovery expenses, lost wages, and other costs associated with their illness. Furthermore, they may also be able to receive compensation for their pain and suffering or for permanent disabilities caused by these medications.
However, it is difficult for an individual to recover these expenses without legal assistance. A personal injury attorney can examine the victim’s case, discuss the injuries sustained, and determine the best way to collect damages from the manufacturer if there is a question of product liability.